Observational Pharmacokinetic Study Of GW679769 In Subjects With Renal Impairment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-08

Study Completion Date

2008-08-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Vomiting

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Subjects receiving casopitant

Eligible subjects will receive a 100 milligrams oral dose of casopitant once daily for five consecutive days.

Group Type EXPERIMENTAL

Casopitant

Intervention Type DRUG

Casopitant oral tablets will be available with a dose of 50 milligrams.

Interventions

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Casopitant

Casopitant oral tablets will be available with a dose of 50 milligrams.

Intervention Type DRUG

Other Intervention Names

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GW679769

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Miramar, Florida, United States

Site Status

GSK Investigational Site

Orlando, Florida, United States

Site Status

GSK Investigational Site

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Study Documents

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