Study To Examine Safety, Tolerability And Pharmacokinetics Of Intravenous Doses And Oral Dose Of GSK233705
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
GSK233705
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Muscarinic Receptor Antagonist,, intravenous infusion,, pharmacokinetics, healthy subjects,, safety,, tolerability,, Anticholinergic,, oral dosing,
Eligibility Criteria
Inclusion Criteria:
- Healthy male subjects;
- Between the ages of 18-55 years, inclusive
- Body mass index within the range 18.0 to 30.0 kg/m2.
- Non-smokers
- Adequate venous access for intermittent cannulation
- A signed and dated written informed consent is obtained from the subject
- The subject is capable of giving informed consent
- Available to complete the study
Exclusion Criteria:
- Any clinically important abnormality identified in the following: at the screening medical assessment
- A mean QTc(B) value at screening >450msec, the QTc(B) of the 3 screening ECGs are not within 10% of the mean, a PR interval outside the range 90-210msec or an ECG that is not suitable for QT measurements
- A history of elevated resting blood pressure or a mean blood pressure higher than 140/90 mmHg at screening.
- A mean heart rate outside the range of 40-90 bpm at screening.
- History of use of tobacco- or nicotine-containing products within 6 months of screening or a positive cotinine test at screening.
- The subject has donated a unit (400ml) of blood within 60 days of screening, or, intends to donate during the study.
- The subject is currently taking regular (or course of) medication, whether prescribed or not, including herbal remedies such as St John's Wort.
- The subject has taken: prescription medications within the past 2 weeks prior to dosing, or OTC medications (except simple analgesics) within 48 hours prior to dosing, unless it is judged by the Investigator not to compromise their safety or influence the outcome of the study.
- The subject has participated in a study with a new molecular entity within a period of 3 months prior to dosing.
- The subject has tested positive for hepatitis C antibody, hepatitis B surface antigen or HIV
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Subjects receiving GSK233705
Arm Description
Each subject will receive one or more ascending doses given as a constant rate IV infusion over 30 minutes and a single oral dose of 250 microgram GSK233705 solution. IV doses will include 30, 70, 110 microgram of GSK233705 at specified time points.
Outcomes
Primary Outcome Measures
Safety and tolerability of GSK233705: lead II monitoring out to 8 hours post dose,
measurement of heart rate, blood pressure and ECG, Holter monitoring and laboratory data out to 24 hours and
review of adverse events ongoing through out study.
Secondary Outcome Measures
Plasma and urine concentrations of GSK233705 and derived pharmacokinetic parameters, out to 48 hours post dose.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00500461
Brief Title
Study To Examine Safety, Tolerability And Pharmacokinetics Of Intravenous Doses And Oral Dose Of GSK233705
Official Title
A Single-centre, Open-label, Sequential Ascending Cross Over Study to Examine Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Ascending Single Doses, Nominally 10, 30, 70 and 110µg Intravenous Doses and a Single 250µg Oral Dose of GSK233705 in Healthy Volunteers.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
June 4, 2007 (Actual)
Primary Completion Date
July 1, 2007 (Actual)
Study Completion Date
July 25, 2007 (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
GSK233705 is being developed for the treatment of chronic obstructive pulmonary disease. This will be an open-label, dose-ascending study in 7 healthy male subjects to establish well tolerated intravenous doses and an oral dose of GSK233705. The main objective of the study is to confirm an IV and oral dose for a definitive human radiolabel metabolic study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Muscarinic Receptor Antagonist,, intravenous infusion,, pharmacokinetics, healthy subjects,, safety,, tolerability,, Anticholinergic,, oral dosing,
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subjects receiving GSK233705
Arm Type
Experimental
Arm Description
Each subject will receive one or more ascending doses given as a constant rate IV infusion over 30 minutes and a single oral dose of 250 microgram GSK233705 solution. IV doses will include 30, 70, 110 microgram of GSK233705 at specified time points.
Intervention Type
Drug
Intervention Name(s)
GSK233705
Intervention Description
GSK233705 will be available as IV infusion and oral solution containing Cellobiose octaacetate.
Primary Outcome Measure Information:
Title
Safety and tolerability of GSK233705: lead II monitoring out to 8 hours post dose,
Time Frame
out to 8 hours post dose
Title
measurement of heart rate, blood pressure and ECG, Holter monitoring and laboratory data out to 24 hours and
Time Frame
out to 24 hours
Title
review of adverse events ongoing through out study.
Time Frame
through out study.
Secondary Outcome Measure Information:
Title
Plasma and urine concentrations of GSK233705 and derived pharmacokinetic parameters, out to 48 hours post dose.
Time Frame
out to 48 hours post dose.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male subjects;
Between the ages of 18-55 years, inclusive
Body mass index within the range 18.0 to 30.0 kg/m2.
Non-smokers
Adequate venous access for intermittent cannulation
A signed and dated written informed consent is obtained from the subject
The subject is capable of giving informed consent
Available to complete the study
Exclusion Criteria:
Any clinically important abnormality identified in the following: at the screening medical assessment
A mean QTc(B) value at screening >450msec, the QTc(B) of the 3 screening ECGs are not within 10% of the mean, a PR interval outside the range 90-210msec or an ECG that is not suitable for QT measurements
A history of elevated resting blood pressure or a mean blood pressure higher than 140/90 mmHg at screening.
A mean heart rate outside the range of 40-90 bpm at screening.
History of use of tobacco- or nicotine-containing products within 6 months of screening or a positive cotinine test at screening.
The subject has donated a unit (400ml) of blood within 60 days of screening, or, intends to donate during the study.
The subject is currently taking regular (or course of) medication, whether prescribed or not, including herbal remedies such as St John's Wort.
The subject has taken: prescription medications within the past 2 weeks prior to dosing, or OTC medications (except simple analgesics) within 48 hours prior to dosing, unless it is judged by the Investigator not to compromise their safety or influence the outcome of the study.
The subject has participated in a study with a new molecular entity within a period of 3 months prior to dosing.
The subject has tested positive for hepatitis C antibody, hepatitis B surface antigen or HIV
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
London
ZIP/Postal Code
NW10 7NS
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.
Citations:
Citation
This study has not been published in the scientific literature.
Results Reference
background
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
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
AC2106213
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
AC2106213
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
AC2106213
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
AC2106213
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
AC2106213
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
AC2106213
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
AC2106213
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
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Study To Examine Safety, Tolerability And Pharmacokinetics Of Intravenous Doses And Oral Dose Of GSK233705
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