Back to resultsA Study to Investigate the Effect of SB-705498 on Chronic Cough
Primary Purpose
Rhinitis
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Placebo
SB-705498
Sponsored by
About this trial
This is an interventional treatment trial for Rhinitis
Eligibility Criteria
Inclusion Criteria:
- Male or female between 30 -75 (Part A) and 18-75 (Part B) years of age inclusive.
- Non-child bearing women or women of child bearing potential if they agree to use contraception as indicated by the protocol
- Non-smoker for at least 6 months with a pack history <5 pack years (Pack years = (No. of cigarettes smoked/day/20) x No. of years smoked).
- Body weight > 50 kg and body mass index (BMI) within the range 19 - 30.0 kg/m2 (inclusive).
- Capable of giving written informed consent.
- Agree to use contraception listed as acceptable
- Normal 12-lead ECG at screening.
- Chronic cough (Part B only)
- Good general health, apart from chronic cough (part B only), as determined by a responsible physician.
Exclusion Criteria:
- A history of gastrointestinal, hepatic, renal or multiple cardiovascular risk factors.
- Positive pre-study drug/alcohol screen.
- Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- A positive test for human immunodeficiency virus (HIV) antibody (if determined by the local standard operating procedures (SOPs)).
- History of regular alcohol consumption within 6 months of the study.
- Exposure to more than four new chemical entities within 12 months prior to the start of the study.
- Participation in a clinical trial with a new molecule entity or any other clinical trial within 30 days of the start of the study.
- Use of prescription or non-prescription drugs, as well as of vitamins, herbal and dietary supplements (including St John's Wort) within 7 days prior to study.
- known history of lung cancer
- current treatment with oral corticosteriods or other immunosupressive agents
- FEV1 less than 80% of predicted value at screening
- Any subject who does not reach C5 following 250uM oral capsaicin
- History of drug or other allergy that, in the opinion of the Investigator or GSK Medical Monitor, contraindicates their participation.
- Donation of blood or blood products in excess of 500mL within a 56 day period prior the start study.
- Pregnant females as determined by positive serum or urine human chorionic gonadotropin (hCG) test at screening or prior to dosing.
- Lactating females.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days prior to dosing.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Arm 1
Arm 2
Arm Description
incremental doses capsaicin
incremenrtal doses casaicin
Outcomes
Primary Outcome Measures
Pharmacokinetic parameter of area under the plasma concentration-time curve from time zero to 4 hours AUC(0-4) and from time zero (pre-dose) to last time of quantifiable concentration AUC(0-t)- Part A
AUC(0-4) is a measure of the average amount of study drug in the blood plasma over a period of 4 hours after the dose and AUC(0-t) is a measure average amount of study drug in the blood plasma over a period of last time of quantifiable concentration. Both the parameters were calculated by standard non-compartmental analysis. Blood samples for PK analysis were obtained at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 10 hours post-dose.
Maximum observed concentration (Cmax) following 10 hour sampling of a single dose of SB-705498 - Part A
Cmax is defined as the maximum or "peak" concentration of a drug observed after its administration. Cmax is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed. It was calculated by standard non-compartmental analysis. Blood samples for PK analysis were obtained at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 10 hours post-dose.
Time of occurrence of Cmax (Tmax) following 10 hour sampling of a single dose of SB-705498 -Part A
Tmax is defined as the time of occurrence of Cmax. Blood samples for PK analysis were obtained at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 10 hours post-dose.
Capsaicin concentration required to achieve Five or more coughs (C5) following a single dose of SB-705498 at Tmax as compared to baseline- Part A
The concentration of capsaicin required to elicit 5 coughs was analyzed. The distributional properties were investigated, and the endpoint was logged (base 2) for analysis and the difference from Day -1 (baseline) was taken (equivalent to ratio on log scale).
Capsaicin concentration required to achieve C5 following a single dose of SB-705498 or placebo- Part B
The concentration of capsaicin required to elicit 5 coughs was analyzed. The distributional properties were investigated, and the endpoint was logged (base 2) for analysis and the difference from Day -1 (baseline) was taken (equivalent to ratio on log scale).
Cough Count Per 24 hour following single dose of SB-705498 as compared to placebo- Part B
24 hour cough count (rate/h) following single dose of SB-705498 as compared to placebo were analyzed by first log transforming the cough counts taken on Day -1 and on Day 1 of each period in the 24 hours post dose. The cough count rates were log(10) transformed.
Secondary Outcome Measures
Capsaicin concentration required to achieve two or more coughs (C2) following a single dose of SB-705498 at Tmax as compared to baseline- Part A
The concentration of capsaicin required to elicit 2 coughs was analyzed. The distributional properties were investigated, and the endpoint was logged (base 2) for analysis and the difference from Day -1 (baseline) was taken (equivalent to ratio on log scale).
Capsaicin concentration required to achieve C2 following a single dose of SB-705498 at Tmax as compared to baseline- Part B
Changes in the Cough Quality of Life Questionnaire (CQLQ) following a single dose of SB-705498 compared to placebo- Part B
It is a validated, 28-item assessment tool designed to evaluate decrements in quality of life due to chronic cough. This questionnaire measures cough-related symptoms, as well as the social implications and psychological impact. Examples of items include, "I cannot sleep at night" and "I cough and it makes me retch." The final score is obtained by summing the responses to 28 questions, each scored on a 1-4 scale, where 1 is "strongly disagree," and 4 is "strongly agree." The minimum and maximum CQLQ scores are 28 and 112 respectively, with increasing score indicating more severe impairment.
Urge to cough Visual Analogue Scale (VAS) following single dose of SB-705498- Part B
VAS following single dose of SB-705498 was summarized on Day -1, and Day 1 pre-dose, 2 and 24 hours.
Capsaicin concentration required to achieve C5 following a single dose of SB-705498 at 24 hours as compared to baseline-Part B
The concentration of capsaicin required to elicit 5 coughs was analyzed. The distributional properties were investigated, and the endpoint was logged (base 2) for analysis and the difference from Day -1 (baseline) was taken (equivalent to ratio on log scale).
Capsaicin concentration required to achieve C2 following a single dose of SB-705498 at 24 hours as compared to baseline- Part B
The concentration of capsaicin required to elicit 2 coughs was analyzed. The distributional properties were investigated, and the endpoint was logged (base 2) for analysis and the difference from Day -1 (baseline) was taken (equivalent to ratio on log scale).
The 24-hour cough count (rate) subdivided by day and night cough counts (rates) to give day/night specific values by treatment group-Part B
Different cough intervals were investigated, such as a day and night time rate. Participants were treated as a random effect in the model. The mean treatment difference and associated 95% confidence interval was back-transformed to provide a treatment ratio and 95% confidence interval for the ratio.
Number participants with Adverse Events(AEs) and serious adverse events (SAEs)- Part A
An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
Number participants with AEs and SAEs- Part B
An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
Summary of vital signs -systolic and diastolic blood pressure (Part A)
Systolic and diastolic blood pressure was assessed on pre dose and 2, 10 hours post dose.
Summary of vital signs -systolic and diastolic blood pressure (Part B)
Systolic and diastolic blood pressure was assessed on pre dose and 4 hours post dose.
Summary of Vital Signs- Heart rate (Part A)
Heart rate was assessed on pre dose and 2, 10 hours post dose.
Summary of Vital Signs- Heart rate (Part B)
Heart rate was assessed on pre dose and 4 hours post dose.
Summary of Vital Signs- Body temperature (Part A)
Body temperature was measured with a tympanic thermometer at pre-dose, 1, 2, 4, 10 hours post dose.
Summary of Vital Signs- Body temperature (Part B)
Body temperature was measured with a tympanic thermometer at pre-dose, 1, 2, 4, 24 hours post dose.
Number of participants with ECG findings- Part A
Single 12-lead ECGs was obtained at each time point during the study using an ECG machine. Participants with abnormal values have been presented.
Number of participants with ECG findings- Part B
Single 12-lead ECGs was obtained at each time point during the study using an ECG machine. Participants with abnormal values have been presented.
Number of participants with potential clinical importance (PCI) laboratory assessments- hematology Part A
Hematology PCI values were: White Blood Cell Count; 0.67 (low) and 1.82 (high), Neutrophil Count; 0.83 (low), Hemoglobin (male); 1.03 (high), Hemoglobin (female); 1.13 (high), Hematocrit (male); 1.02 (high), Hematocrit (female); 1.17(high), Platelet Count; 0.67 and 1.57 (high), Lymphocytes; 0.81 (low).
Number of participants with potential clinical importance (PCI) laboratory assessments- hematology Part B
Hematology PCI values were: White Blood Cell Count; 0.67 (low) and 1.82 (high), Neutrophil Count; 0.83 (low), Hemoglobin (male); 1.03 (high), Hemoglobin (female); 1.13 (high), Hematocrit (male); 1.02 (high), Hematocrit (female); 1.17(high), Platelet Count; 0.67 and 1.57 (high), Lymphocytes; 0.81 (low).
Number of participants with potential clinical importance (PCI) laboratory assessments- clinical biochemistry Part A
Clinical biochemistry PCI values were: Albumin; 0.86 (low), Calcium; 0.91(low) and 1.06 (high), Glucose; 0.71 (low) and 1.41 (high), Potassium; 0.86 (low) and 1.10 (high), Sodium; 0.96(low) and 1.03(high).
Number of participants with potential clinical importance (PCI) laboratory assessments- clinical biochemistry Part B
Clinical biochemistry PCI values were: Albumin; 0.86 (low), Calcium; 0.91(low) and 1.06 (high), Glucose; 0.71 (low) and 1.41 (high), Potassium; 0.86 (low) and 1.10 (high), Sodium; 0.96(low) and 1.03(high).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01476098
Brief Title
A Study to Investigate the Effect of SB-705498 on Chronic Cough
Official Title
Two Part Study to Investigate Pharmacokinetics (PK) & Pharamcodynamics (PD) of SB-705498 in Cough. Part A:Open Label Study in Healthy Subjects to Determine Exposure to SB-705498. Part B:Double-blind, Placebo Controlled, Cross Over Study to Investigate Effect of SB-705498 on Capsaicin Induced Cough and 24 Hour Cough Counts in Cough Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is designed to loook at the affect of oral SB-705498 on cough following an inhaled capsaicin challenge
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Placebo Comparator
Arm Description
incremental doses capsaicin
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
incremenrtal doses casaicin
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
SB-705498 placebo
Intervention Type
Drug
Intervention Name(s)
SB-705498
Intervention Description
400 or 600mg oral SB-705498
Primary Outcome Measure Information:
Title
Pharmacokinetic parameter of area under the plasma concentration-time curve from time zero to 4 hours AUC(0-4) and from time zero (pre-dose) to last time of quantifiable concentration AUC(0-t)- Part A
Description
AUC(0-4) is a measure of the average amount of study drug in the blood plasma over a period of 4 hours after the dose and AUC(0-t) is a measure average amount of study drug in the blood plasma over a period of last time of quantifiable concentration. Both the parameters were calculated by standard non-compartmental analysis. Blood samples for PK analysis were obtained at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 10 hours post-dose.
Time Frame
pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 10 hours post-dose
Title
Maximum observed concentration (Cmax) following 10 hour sampling of a single dose of SB-705498 - Part A
Description
Cmax is defined as the maximum or "peak" concentration of a drug observed after its administration. Cmax is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed. It was calculated by standard non-compartmental analysis. Blood samples for PK analysis were obtained at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 10 hours post-dose.
Time Frame
pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 10 hours post-dose Day 1
Title
Time of occurrence of Cmax (Tmax) following 10 hour sampling of a single dose of SB-705498 -Part A
Description
Tmax is defined as the time of occurrence of Cmax. Blood samples for PK analysis were obtained at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 10 hours post-dose.
Time Frame
pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 10 hours post-dose
Title
Capsaicin concentration required to achieve Five or more coughs (C5) following a single dose of SB-705498 at Tmax as compared to baseline- Part A
Description
The concentration of capsaicin required to elicit 5 coughs was analyzed. The distributional properties were investigated, and the endpoint was logged (base 2) for analysis and the difference from Day -1 (baseline) was taken (equivalent to ratio on log scale).
Time Frame
Day -1 (baseline) and Day 1 (2 hours post dose
Title
Capsaicin concentration required to achieve C5 following a single dose of SB-705498 or placebo- Part B
Description
The concentration of capsaicin required to elicit 5 coughs was analyzed. The distributional properties were investigated, and the endpoint was logged (base 2) for analysis and the difference from Day -1 (baseline) was taken (equivalent to ratio on log scale).
Time Frame
Day -1, Day 1 (2hrs and 24 hrs post dose)
Title
Cough Count Per 24 hour following single dose of SB-705498 as compared to placebo- Part B
Description
24 hour cough count (rate/h) following single dose of SB-705498 as compared to placebo were analyzed by first log transforming the cough counts taken on Day -1 and on Day 1 of each period in the 24 hours post dose. The cough count rates were log(10) transformed.
Time Frame
Day -1 and Day 1 (2 and 24 hours)
Secondary Outcome Measure Information:
Title
Capsaicin concentration required to achieve two or more coughs (C2) following a single dose of SB-705498 at Tmax as compared to baseline- Part A
Description
The concentration of capsaicin required to elicit 2 coughs was analyzed. The distributional properties were investigated, and the endpoint was logged (base 2) for analysis and the difference from Day -1 (baseline) was taken (equivalent to ratio on log scale).
Time Frame
Day -1 and Day 1 (2 hours post dose)
Title
Capsaicin concentration required to achieve C2 following a single dose of SB-705498 at Tmax as compared to baseline- Part B
Time Frame
Day 1 (2 and 24 hours post dose)
Title
Changes in the Cough Quality of Life Questionnaire (CQLQ) following a single dose of SB-705498 compared to placebo- Part B
Description
It is a validated, 28-item assessment tool designed to evaluate decrements in quality of life due to chronic cough. This questionnaire measures cough-related symptoms, as well as the social implications and psychological impact. Examples of items include, "I cannot sleep at night" and "I cough and it makes me retch." The final score is obtained by summing the responses to 28 questions, each scored on a 1-4 scale, where 1 is "strongly disagree," and 4 is "strongly agree." The minimum and maximum CQLQ scores are 28 and 112 respectively, with increasing score indicating more severe impairment.
Time Frame
Day -1 and 14
Title
Urge to cough Visual Analogue Scale (VAS) following single dose of SB-705498- Part B
Description
VAS following single dose of SB-705498 was summarized on Day -1, and Day 1 pre-dose, 2 and 24 hours.
Time Frame
Day -1 and Day 1 (pre-dose 2 and 24 hours)
Title
Capsaicin concentration required to achieve C5 following a single dose of SB-705498 at 24 hours as compared to baseline-Part B
Description
The concentration of capsaicin required to elicit 5 coughs was analyzed. The distributional properties were investigated, and the endpoint was logged (base 2) for analysis and the difference from Day -1 (baseline) was taken (equivalent to ratio on log scale).
Time Frame
Day -1 and Day 1 (2 and 24 hours post dose)
Title
Capsaicin concentration required to achieve C2 following a single dose of SB-705498 at 24 hours as compared to baseline- Part B
Description
The concentration of capsaicin required to elicit 2 coughs was analyzed. The distributional properties were investigated, and the endpoint was logged (base 2) for analysis and the difference from Day -1 (baseline) was taken (equivalent to ratio on log scale).
Time Frame
Day -1 and Day 1 (2 and 24 hours post dose)
Title
The 24-hour cough count (rate) subdivided by day and night cough counts (rates) to give day/night specific values by treatment group-Part B
Description
Different cough intervals were investigated, such as a day and night time rate. Participants were treated as a random effect in the model. The mean treatment difference and associated 95% confidence interval was back-transformed to provide a treatment ratio and 95% confidence interval for the ratio.
Time Frame
Up to Day 2 (Period 2)
Title
Number participants with Adverse Events(AEs) and serious adverse events (SAEs)- Part A
Description
An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
Time Frame
Up to Day 7
Title
Number participants with AEs and SAEs- Part B
Description
An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
Time Frame
up to Day 42
Title
Summary of vital signs -systolic and diastolic blood pressure (Part A)
Description
Systolic and diastolic blood pressure was assessed on pre dose and 2, 10 hours post dose.
Time Frame
Up to Day 7
Title
Summary of vital signs -systolic and diastolic blood pressure (Part B)
Description
Systolic and diastolic blood pressure was assessed on pre dose and 4 hours post dose.
Time Frame
Up to Day 42
Title
Summary of Vital Signs- Heart rate (Part A)
Description
Heart rate was assessed on pre dose and 2, 10 hours post dose.
Time Frame
Up to Day 7
Title
Summary of Vital Signs- Heart rate (Part B)
Description
Heart rate was assessed on pre dose and 4 hours post dose.
Time Frame
Up to Day 42
Title
Summary of Vital Signs- Body temperature (Part A)
Description
Body temperature was measured with a tympanic thermometer at pre-dose, 1, 2, 4, 10 hours post dose.
Time Frame
Up to Day 7
Title
Summary of Vital Signs- Body temperature (Part B)
Description
Body temperature was measured with a tympanic thermometer at pre-dose, 1, 2, 4, 24 hours post dose.
Time Frame
Up to Day 42
Title
Number of participants with ECG findings- Part A
Description
Single 12-lead ECGs was obtained at each time point during the study using an ECG machine. Participants with abnormal values have been presented.
Time Frame
Up to Day 7
Title
Number of participants with ECG findings- Part B
Description
Single 12-lead ECGs was obtained at each time point during the study using an ECG machine. Participants with abnormal values have been presented.
Time Frame
Up to Day 42
Title
Number of participants with potential clinical importance (PCI) laboratory assessments- hematology Part A
Description
Hematology PCI values were: White Blood Cell Count; 0.67 (low) and 1.82 (high), Neutrophil Count; 0.83 (low), Hemoglobin (male); 1.03 (high), Hemoglobin (female); 1.13 (high), Hematocrit (male); 1.02 (high), Hematocrit (female); 1.17(high), Platelet Count; 0.67 and 1.57 (high), Lymphocytes; 0.81 (low).
Time Frame
Up to 4 weeks
Title
Number of participants with potential clinical importance (PCI) laboratory assessments- hematology Part B
Description
Hematology PCI values were: White Blood Cell Count; 0.67 (low) and 1.82 (high), Neutrophil Count; 0.83 (low), Hemoglobin (male); 1.03 (high), Hemoglobin (female); 1.13 (high), Hematocrit (male); 1.02 (high), Hematocrit (female); 1.17(high), Platelet Count; 0.67 and 1.57 (high), Lymphocytes; 0.81 (low).
Time Frame
Up to 13 weeks
Title
Number of participants with potential clinical importance (PCI) laboratory assessments- clinical biochemistry Part A
Description
Clinical biochemistry PCI values were: Albumin; 0.86 (low), Calcium; 0.91(low) and 1.06 (high), Glucose; 0.71 (low) and 1.41 (high), Potassium; 0.86 (low) and 1.10 (high), Sodium; 0.96(low) and 1.03(high).
Time Frame
Up to 4 weeks
Title
Number of participants with potential clinical importance (PCI) laboratory assessments- clinical biochemistry Part B
Description
Clinical biochemistry PCI values were: Albumin; 0.86 (low), Calcium; 0.91(low) and 1.06 (high), Glucose; 0.71 (low) and 1.41 (high), Potassium; 0.86 (low) and 1.10 (high), Sodium; 0.96(low) and 1.03(high).
Time Frame
Up to 13 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female between 30 -75 (Part A) and 18-75 (Part B) years of age inclusive.
Non-child bearing women or women of child bearing potential if they agree to use contraception as indicated by the protocol
Non-smoker for at least 6 months with a pack history <5 pack years (Pack years = (No. of cigarettes smoked/day/20) x No. of years smoked).
Body weight > 50 kg and body mass index (BMI) within the range 19 - 30.0 kg/m2 (inclusive).
Capable of giving written informed consent.
Agree to use contraception listed as acceptable
Normal 12-lead ECG at screening.
Chronic cough (Part B only)
Good general health, apart from chronic cough (part B only), as determined by a responsible physician.
Exclusion Criteria:
A history of gastrointestinal, hepatic, renal or multiple cardiovascular risk factors.
Positive pre-study drug/alcohol screen.
Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
A positive test for human immunodeficiency virus (HIV) antibody (if determined by the local standard operating procedures (SOPs)).
History of regular alcohol consumption within 6 months of the study.
Exposure to more than four new chemical entities within 12 months prior to the start of the study.
Participation in a clinical trial with a new molecule entity or any other clinical trial within 30 days of the start of the study.
Use of prescription or non-prescription drugs, as well as of vitamins, herbal and dietary supplements (including St John's Wort) within 7 days prior to study.
known history of lung cancer
current treatment with oral corticosteriods or other immunosupressive agents
FEV1 less than 80% of predicted value at screening
Any subject who does not reach C5 following 250uM oral capsaicin
History of drug or other allergy that, in the opinion of the Investigator or GSK Medical Monitor, contraindicates their participation.
Donation of blood or blood products in excess of 500mL within a 56 day period prior the start study.
Pregnant females as determined by positive serum or urine human chorionic gonadotropin (hCG) test at screening or prior to dosing.
Lactating females.
Unwillingness or inability to follow the procedures outlined in the protocol.
Cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days prior to dosing.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Manchester
ZIP/Postal Code
M23 9QZ
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
114693
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
114693
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
114693
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
114693
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
114693
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
114693
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
114693
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
A Study to Investigate the Effect of SB-705498 on Chronic Cough
We'll reach out to this number within 24 hrs