Observational Pharmacokinetic Study Of GW679769 In Subjects With Renal Impairment

• Status: Completed
• Trial end date: 2008-08-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Casopitant

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.