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

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

Official Title
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An Open-Label, Two Period, Fixed Sequence Study of Healthy Subjects to Assess the Effect of Repeat Oral Dosing of [Rifampin] on the Pharmacokinetics of a Single Oral Dose of [GW679769]

Conditions
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Nausea and Vomiting, Chemotherapy-Induced

Intervention / Treatment
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* Drug: GW679769 (Casopitant) oral tablets
* Drug: Rifampin oral capsules


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Period 1<br>Subject will receive single oral dose of 150 milligram (mg) of Casopitant. There will be wash out period of 7 days. | Drug: GW679769 (Casopitant) oral tablets<br>* Casopitant tablets will be available with dose strength of 50 mg. Subjects will receive three 50 mg tablets for the dose of 150 mg. On Day 8 of Treatment Period 2, the dose of casopitant and rifampin is to be taken at the same time.<br>|
| Experimental: Treatment Period 2<br>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. | Drug: GW679769 (Casopitant) oral tablets<br>* Casopitant tablets will be available with dose strength of 50 mg. Subjects will receive three 50 mg tablets for the dose of 150 mg. On Day 8 of Treatment Period 2, the dose of casopitant and rifampin is to be taken at the same time.<br>Drug: Rifampin oral capsules<br>* Rifampin capsules will be available with dose strength of 300 mg. Subjects will receive two 300 mg capsules for the dose of 600 mg. On Day 8 of Treatment Period 2, the dose of casopitant and rifampin is to be taken at the same time.<br>* Other names: GW679769 (Casopitant) oral tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma levels for casopitant will be measured in Period 1 at Day 1 to 3 and in Period 2 at Day 8. Plasma levels for rifampin will be measured in Period 2 at Day 8 to 10. |  | Up to Day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical lab tests adverse events vital signs 12 lead ECGs liver function tests |  | Up to Day 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rifampin GW679769