Nausea and Vomiting, Chemotherapy-Induced
Conditions
Keywords
Rifampin GW679769
Brief summary
This study will examine what the body does while taking GW679769 alone and together with rifampin in healthy adult subjects.
Interventions
DRUGGW679769 (Casopitant) oral tablets
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.
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.
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| clinical lab tests adverse events vital signs 12 lead ECGs liver function tests | Up to Day 12 |
Countries
United States
Outcome results
None listed