HIV Infections
Conditions
Brief summary
An oral dose in healthy and renally impaired subjects to determine the drug effect for BMS-663068.
Interventions
DRUGOral BMS-663068 (pro-drug)
Oral BMS-663068 (pro-drug), metabolized to active BMS-626529
Sponsors
GlaxoSmithKline
ViiV Healthcare
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
(For renal impaired subjects): * Classification by renal function based on eGFR * Clinical, ECG, and laboratory findings consistent with renal dysfunction * BMI of 18.0 to 38.0 kg/m2 inclusive * Women of child bearing potential (WOCBP) and sexually active fertile men with partners who are WOCBP must use non-hormonal highly effective birth control * Slightly different inclusion criteria are defined in the protocol for healthy subjects
Exclusion criteria
* History of uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening * Evidence of rapidly deteriorating renal function, defined as a screening eGFR that has decreased from a previous eGFR by ≥ 50% within the last 3 months * Current or recent (within 3 months of study drug administration) clinically significant gastrointestinal disease or gastrointestinal surgery (including cholecystectomy) that could impact the absorption of study drug * Any major surgery within 4 weeks of study drug administration. * Other protocol defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Renal Impairment on The Primary Endpoints of Cmax | Day 1 - Day 5 | To assess the effect of varying degrees of renal impairment on the exposure of BMS-626529 after a single oral-dose administration of the pro-drug, BMS-663068, will be evaluated by assessing the primary endpoints of Cmax, for BMS-626529. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability as assessed by the Incidence of Serious Adverse Events (SAEs), Adverse Events (AEs), AEs leading to discontinuation, and the results of ECGs, vital signs, physical examination, and clinical laboratory tests. | Day 1 - Day 5 | To assess the safety and tolerability of BMS-663068 in subjects with normal renal function and subjects with impaired renal functions, will be measured by the following secondary endpoints: Incidence of AEs, Serious Adverse Events (SAEs), and AEs leading to discontinuation, and results of vital signs, ECGs, physical examination, and clinical laboratory tests. |
Countries
United States
Outcome results
None listed