Clinical trial NCT00358813: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Vomiting
Keywords: emesis
renal impairment
GW679769
kidney problems
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-08-01
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Area under the plasma drug concentration versus time curve from 0 to 24 hours (AUC[0-24]) of casopitant and GSK525060
timeFrame: 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
measure: Maximum observed concentration (Cmax) of casopitant and GSK525060
timeFrame: 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 outcomes:
measure: Time to maximum observed plasma drug concentration (Tmax) of casopitant and GSK525060
timeFrame: 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
measure: Half-life of casopitant and GSK525060
timeFrame: 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
measure: Free fraction (percent unbound) of casopitant and GSK525060
timeFrame: 1,2,4 and 24 hours post-dose on Day 1; pre-dose,1,2,4 and 24 hours post-dose on Day 5
measure: Number of subjects with adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Up to Day 22
measure: Number of subjects with abnormal values for blood pressure
timeFrame: Up to Day 22
measure: Number of subjects with abnormal values for heart rate
timeFrame: Up to Day 22
measure: Number of subjects with abnormal findings after weight measurement
timeFrame: Up to Day 22
measure: Number of subjects having abnormal hematology laboratory parameters as a measure of safety
timeFrame: Up to Day 22
measure: Number of subjects having abnormal clinical Chemistry laboratory parameters as a measure of safety
timeFrame: Up to Day 22
measure: Number of subjects having abnormal values for urinalysis as a measure of safety
timeFrame: Up to Day 22
measure: Number of subjects with abnormal findings after serological tests
timeFrame: Up to Day 22
Other outcomes:
Locations:
city: Miramar
country: United States
facility: GSK Investigational Site
state: Florida
city: Orlando
country: United States
facility: GSK Investigational Site
state: Florida
city: Minneapolis
country: United States
facility: GSK Investigational Site
state: Minnesota
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: