Back to resultsObservational Pharmacokinetic Study Of GW679769 In Subjects With Renal Impairment
Primary Purpose
Vomiting
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Casopitant
Sponsored by
About this trial
This is an interventional treatment trial for Vomiting focused on measuring emesis, renal impairment, GW679769, kidney problems
Eligibility Criteria
Inclusion criteria: Healthy or have mild or moderate renal impairment. Females must be of non-childbearing potential(hysterectomy, bilateral oophorectomy, post-menopausal) OR childbearing and must have a negative pregnancy test and meet/comply with one of the following: abstinence, double-barrier contraception, vasectomized partner). Be negative for Hepatitis B and C. Have negative results on drug, alcohol and HIV tests. Have stable renal function. Exclusion criteria: Have a peptic ulcer. Abuse drugs or alcohol. Are pregnant or lactating. Have heart failure. Have uncontrolled emesis. Have an infection. Have taken or received inducers or inhibitors of CYP3A4 or CYP3A5 within 14 days of study start. Active peptic ulcer disease. Digoxin use. Laboratory results that show low iron or pepsinogen levels, AST and CK level >1,5 ULN, or that show stool is positive for occult blood.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Subjects receiving casopitant
Arm Description
Eligible subjects will receive a 100 milligrams oral dose of casopitant once daily for five consecutive days.
Outcomes
Primary Outcome Measures
Area under the plasma drug concentration versus time curve from 0 to 24 hours (AUC[0-24]) of casopitant and GSK525060
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Maximum observed concentration (Cmax) of casopitant and GSK525060
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Secondary Outcome Measures
Time to maximum observed plasma drug concentration (Tmax) of casopitant and GSK525060
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Half-life of casopitant and GSK525060
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Free fraction (percent unbound) of casopitant and GSK525060
Blood samples will be collected for assessment of protein binding of casopitant and GSK525060.
Number of subjects with adverse events (AEs) and serious adverse events (SAEs)
An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment will be categorized as SAE.
Number of subjects with abnormal values for blood pressure
Systolic (SBP) and diastolic blood pressure (DBP) will be measured.
Number of subjects with abnormal values for heart rate
Heart rate will be measured.
Number of subjects with abnormal findings after weight measurement
Weight evaluation will be performed as measure of safety.
Number of subjects having abnormal hematology laboratory parameters as a measure of safety
Hematology parameters will be analyzed as a measure of safety.
Number of subjects having abnormal clinical Chemistry laboratory parameters as a measure of safety
Clinical chemistry parameters will be analyzed as a measure of safety.
Number of subjects having abnormal values for urinalysis as a measure of safety
Urinalysis will be carried out as a measure of safety.
Number of subjects with abnormal findings after serological tests
Serological tests will be performed as a measure of safety.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00358813
Brief Title
Observational Pharmacokinetic Study Of GW679769 In Subjects With Renal Impairment
Official Title
An Open-Label, Non-Randomized, Pharmacokinetic and Safety Study of Multiple Oral Doses of GW679769 in Subjects With Renal Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 8, 2006 (Actual)
Primary Completion Date
August 22, 2008 (Actual)
Study Completion Date
August 22, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to evaluate how subjects with mild or moderate kidney problems process or breakdown the study drug GW679769 in their bodies as compared to healthy subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vomiting
Keywords
emesis, renal impairment, GW679769, kidney problems
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subjects receiving casopitant
Arm Type
Experimental
Arm Description
Eligible subjects will receive a 100 milligrams oral dose of casopitant once daily for five consecutive days.
Intervention Type
Drug
Intervention Name(s)
Casopitant
Other Intervention Name(s)
GW679769
Intervention Description
Casopitant oral tablets will be available with a dose of 50 milligrams.
Primary Outcome Measure Information:
Title
Area under the plasma drug concentration versus time curve from 0 to 24 hours (AUC[0-24]) of casopitant and GSK525060
Description
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 16 hours on Day 1; pre-dose on Day 2, Day 3 and Day 4; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours on Day 5
Title
Maximum observed concentration (Cmax) of casopitant and GSK525060
Description
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 16 hours on Day 1; pre-dose on Day 2, Day 3 and Day 4; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours on Day 5
Secondary Outcome Measure Information:
Title
Time to maximum observed plasma drug concentration (Tmax) of casopitant and GSK525060
Description
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 16 hours on Day 1; pre-dose on Day 2, Day 3 and Day 4; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours on Day 5
Title
Half-life of casopitant and GSK525060
Description
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Time Frame
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 16 hours on Day 1; pre-dose on Day 2, Day 3 and Day 4; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours on Day 5
Title
Free fraction (percent unbound) of casopitant and GSK525060
Description
Blood samples will be collected for assessment of protein binding of casopitant and GSK525060.
Time Frame
1,2,4 and 24 hours post-dose on Day 1; pre-dose,1,2,4 and 24 hours post-dose on Day 5
Title
Number of subjects with adverse events (AEs) and serious adverse events (SAEs)
Description
An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment will be categorized as SAE.
Time Frame
Up to Day 22
Title
Number of subjects with abnormal values for blood pressure
Description
Systolic (SBP) and diastolic blood pressure (DBP) will be measured.
Time Frame
Up to Day 22
Title
Number of subjects with abnormal values for heart rate
Description
Heart rate will be measured.
Time Frame
Up to Day 22
Title
Number of subjects with abnormal findings after weight measurement
Description
Weight evaluation will be performed as measure of safety.
Time Frame
Up to Day 22
Title
Number of subjects having abnormal hematology laboratory parameters as a measure of safety
Description
Hematology parameters will be analyzed as a measure of safety.
Time Frame
Up to Day 22
Title
Number of subjects having abnormal clinical Chemistry laboratory parameters as a measure of safety
Description
Clinical chemistry parameters will be analyzed as a measure of safety.
Time Frame
Up to Day 22
Title
Number of subjects having abnormal values for urinalysis as a measure of safety
Description
Urinalysis will be carried out as a measure of safety.
Time Frame
Up to Day 22
Title
Number of subjects with abnormal findings after serological tests
Description
Serological tests will be performed as a measure of safety.
Time Frame
Up to Day 22
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
Healthy or have mild or moderate renal impairment.
Females must be of non-childbearing potential(hysterectomy, bilateral oophorectomy, post-menopausal) OR childbearing and must have a negative pregnancy test and meet/comply with one of the following: abstinence, double-barrier contraception, vasectomized partner).
Be negative for Hepatitis B and C.
Have negative results on drug, alcohol and HIV tests.
Have stable renal function.
Exclusion criteria:
Have a peptic ulcer.
Abuse drugs or alcohol.
Are pregnant or lactating.
Have heart failure.
Have uncontrolled emesis.
Have an infection.
Have taken or received inducers or inhibitors of CYP3A4 or CYP3A5 within 14 days of study start.
Active peptic ulcer disease.
Digoxin use.
Laboratory results that show low iron or pepsinogen levels, AST and CK level >1,5 ULN, or that show stool is positive for occult blood.
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
Miramar
State/Province
Florida
ZIP/Postal Code
33025
Country
United States
Facility Name
GSK Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Facility Name
GSK Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
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
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
NKT102783
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
NKT102783
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
NKT102783
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
NKT102783
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
NKT102783
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
NKT102783
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
NKT102783
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Observational Pharmacokinetic Study Of GW679769 In Subjects With Renal Impairment
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