An Open-Label, Non-Randomized, Pharmacokinetic and Safety Study of Multiple Oral Doses of GW679769 in Subjects With Renal Impairment
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Area under the plasma drug concentration versus time curve from 0 to 24 hours (AUC[0-24]) of casopitant and GSK525060
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Subjects receiving casopitant
Eligible subjects will receive a 100 milligrams oral dose of casopitant once daily for five consecutive days.
Intervention: Casopitant (Drug)
Outcomes
Primary Outcomes
Area under the plasma drug concentration versus time curve from 0 to 24 hours (AUC[0-24]) of casopitant and GSK525060
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
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Maximum observed concentration (Cmax) of casopitant and GSK525060
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
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Secondary Outcomes
- Number of subjects having abnormal values for urinalysis as a measure of safety(Up to Day 22)
- Number of subjects with abnormal findings after serological tests(Up to Day 22)
- Half-life of casopitant and GSK525060(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)
- Time to maximum observed plasma drug concentration (Tmax) of casopitant and GSK525060(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)
- Free fraction (percent unbound) of casopitant and GSK525060(1,2,4 and 24 hours post-dose on Day 1; pre-dose,1,2,4 and 24 hours post-dose on Day 5)
- Number of subjects with adverse events (AEs) and serious adverse events (SAEs)(Up to Day 22)
- Number of subjects with abnormal values for blood pressure(Up to Day 22)
- Number of subjects with abnormal values for heart rate(Up to Day 22)
- Number of subjects with abnormal findings after weight measurement(Up to Day 22)
- Number of subjects having abnormal hematology laboratory parameters as a measure of safety(Up to Day 22)
- Number of subjects having abnormal clinical Chemistry laboratory parameters as a measure of safety(Up to Day 22)