Infection, Human Immunodeficiency Virus
Conditions
Brief summary
The purpose of this study is to estimate the effect of high fat meal and increased gastric pH on BMS-663068 bioavailability
Interventions
DRUGBMS-663068
BMS-663068
Sponsors
GlaxoSmithKline
ViiV Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Signed Informed Consent 2. Target population: Healthy males and females. 3. Males and females 4. Women of child bearing potential (WOCBP) with negative serum or urine pregnancy test 5. Women must not be breastfeeding 6. Men and WOCBP must agree to follow instructions for contraception
Exclusion criteria
1. History of any chronic or acute illness or gastrointestinal disease 2. Any major surgery within 4 weeks of study drug administration 3. Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population. 4. History of allergy to HIV attachment inhibitors, famotidine or high fat meal 5. History of smoking
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed plasma concentration (Cmax) | Days 1-12 |
| Area under the plasma concentration-time curve from time zero extrapolated to infinity, AUC (INF) | Days 1-12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety endpoints include incidence of nonserious AEs, serious AEs, AEs leading to discontinuation | Days 1-12; for SAEs up to 30 days post discontinuation of dosing | Adverse events (both serious and nonserious) will be listed and tabulated by system organ class, preferred term, and treatment. |
Countries
United States
Outcome results
None listed