Infection, Human Immunodeficiency Virus
Conditions
Brief summary
This is a Phase 1, open-label, single sequence, two-way interaction study in healthy male and female subjects. For the effect of maraviroc on the pharmacokinetics (PK) of BMS-626529 (the active moiety of BMS-663068), there is no formal hypothesis to be statistically tested. The purpose of this assessment is to estimate the effect of maraviroc on the PK of BMS-626529 when coadministered in healthy subjects. For the effect of BMS-663068 on the PK of maraviroc, the hypothesis to be statistically tested is that BMS-663068 will not have a clinically significant effect on the PK of maraviroc when coadministered in healthy subjects.
Interventions
DRUGBMS-663068
BMS-663068
DRUGMaraviroc
Maraviroc
Sponsors
GlaxoSmithKline
ViiV Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and female nonsmoking subjects ages 18 to 50 years, inclusive with a body mass index of 18.0 to 32.0 kg/m2, inclusive * Women of childbearing potential must agree to follow instructions for methods of contraception for a total of 34 days post-treatment completion
Exclusion criteria
* Any condition possibly affecting drug absorption * Pre-existing liver dysfunction * Any significant acute or chronic medical illness * Orthostatic intolerance * Other protocol specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BMS-626529 Pharmacokinetics: maximum observed plasma concentration (Cmax) | predose and up to 12 hours post dose on Days 4, 16, 17, and 18 | PK parameters for BMS-626529 in the absence or presence of multiple doses of maraviroc include: \- Cmax |
| BMS-626529 Pharmacokinetics: area under the plasma concentration-time curve (AUC) in a single dosing interval AUC(TAU) | predose and up to 12 hours post dose on Days 4, 16, 17, and 18 | PK parameters for BMS-626529 in the absence or presence of multiple doses of maraviroc include: \- AUC(TAU) |
| Maraviroc Pharmacokinetics: Cmax | predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18 | PK parameters for maraviroc in the absence or presence of BMS-663068 include: \- Cmax |
| Maraviroc Pharmacokinetics: AUC(TAU) | predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18 | PK parameters for maraviroc in the absence or presence of BMS-663068 include: \- AUC(TAU) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Other PK Parameters for maraviroc: C12 | predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18 | PK Parameters for maraviroc include: * C12 |
| Other PK Parameters for maraviroc: Ctrough | predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18 | PK Parameters for maraviroc include: \- Ctrough |
| Clinical Safety as Measured by Adverse Events | Day 1 to Day 26 | Adverse event monitoring |
| Other PK Parameters for BMS-626529: Time of maximum observed plasma concentration (Tmax) | predose and up to 12 hours post dose on Days 4, 16, 17, and 18 | PK parameters for BMS-626529 include: \- Tmax |
| Clinical Safety as Measured by Electrocardiograms (ECGs) | Day 1 to Day 26 | 12-lead ECGs |
| Clinical Safety as Measured by Physical Examination | Day 1 to Day 26 | Physical examinations |
| Clinical Safety as Measured by Clinical Laboratory Evaluations | Day 1 to Day 26 | Clinical chemistry, hematology, urinalysis |
| Clinical Safety as Measured by Vital Signs | Day 1 to Day 26 | Vital sign measurement |
| Other PK Parameters for BMS-626529: plasma concentration observed at 12 hours post-dose (C12) | predose and up to 12 hours post dose on Days 4, 16, 17, and 18 | PK parameters for BMS-626529 include: \- C12 |
| Other PK Parameters for BMS-626529: trough observed plasma concentration (Ctrough) (predose) | predose and up to 12 hours post dose on Days 4, 16, 17, and 18 | PK parameters for BMS-626529 include: \- Ctrough (predose) |
| Other PK Parameters for maraviroc: Tmax | predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18 | PK Parameters for maraviroc include: -Tmax |
Countries
United States
Outcome results
None listed