A Study in Healthy Subjects to Assess How Dosing of Rifampin Affects What the Body Does to a Dose of GW679769 (Casopitant).

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Nausea and Vomiting, Chemotherapy-Induced

Treatments: Drug: GW679769 (Casopitant) oral tablets; Drug: Rifampin oral capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT00405080

NKV105091

Details and patient eligibility

About

This study will examine what the body does while taking GW679769 alone and together with rifampin in healthy adult subjects.

Enrollment: 12 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy
• female subjects who cannot become pregnant
• able to swallow and keep down oral medication
• can understand and follow the protocol requirements and instructions

Exclusion criteria

• smokes at least 4 packs per day in the past 12 months
• use of prescription or non-prescription drug(s)
• herbal or dietary supplements or vitamins with 14 days prior to first dose of study medication
• a clinically relevant abnormality medical condition or circumstance making the subject unsuitable for the study per the study doctor
• blood donation in excess of 1 pint within 56 days before dosing of medication
• iron deficient
• history or drug allergy of study medication
• history of drug or alcohol abuse or dependency within the past 6 months
• subjects cannot use any nicotine-containing products within the last 6 months
• positive for HIV, Hepatitis B or C
• active peptic ulcer disease
• uncontrolled nausea and vomiting
• active infection
• heart failure
• female who is lactating
• female who has a positive pregnancy test

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Treatment Period 1

Experimental group

Description:

Subject will receive single oral dose of 150 milligram (mg) of Casopitant. There will be wash out period of 7 days.

Treatment:

Drug: GW679769 (Casopitant) oral tablets

Treatment Period 2

Experimental group

Description:

Subjects will receive rifampin 600 mg once daily on Days 1 - 9. On Day 8 subjects will receive a single dose of oral casopitant 150 mg along with rifampin.

Treatment:

Drug: Rifampin oral capsules

Drug: GW679769 (Casopitant) oral tablets