Infection, Human Immunodeficiency Virus Clinical Trial
Official title:
A Phase 1, Open-label, Drug-drug Interaction Study Between BMS-663068 and Maraviroc in Healthy Subjects
Verified date | September 2017 |
Source | ViiV Healthcare |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 112 |
Est. completion date | September 21, 2015 |
Est. primary completion date | September 21, 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
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 exclusion criteria could apply |
Country | Name | City | State |
---|---|---|---|
United States | GSK Investigational Site | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
ViiV Healthcare | GlaxoSmithKline |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | BMS-626529 Pharmacokinetics: maximum observed plasma concentration (Cmax) | PK parameters for BMS-626529 in the absence or presence of multiple doses of maraviroc include: - Cmax |
predose and up to 12 hours post dose on Days 4, 16, 17, and 18 | |
Primary | BMS-626529 Pharmacokinetics: area under the plasma concentration-time curve (AUC) in a single dosing interval AUC(TAU) | PK parameters for BMS-626529 in the absence or presence of multiple doses of maraviroc include: - AUC(TAU) |
predose and up to 12 hours post dose on Days 4, 16, 17, and 18 | |
Primary | Maraviroc Pharmacokinetics: Cmax | PK parameters for maraviroc in the absence or presence of BMS-663068 include: - Cmax |
predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18 | |
Primary | Maraviroc Pharmacokinetics: AUC(TAU) | PK parameters for maraviroc in the absence or presence of BMS-663068 include: - AUC(TAU) |
predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18 | |
Secondary | Other PK Parameters for BMS-626529: Time of maximum observed plasma concentration (Tmax) | PK parameters for BMS-626529 include: - Tmax |
predose and up to 12 hours post dose on Days 4, 16, 17, and 18 | |
Secondary | Other PK Parameters for BMS-626529: plasma concentration observed at 12 hours post-dose (C12) | PK parameters for BMS-626529 include: - C12 |
predose and up to 12 hours post dose on Days 4, 16, 17, and 18 | |
Secondary | Other PK Parameters for BMS-626529: trough observed plasma concentration (Ctrough) (predose) | PK parameters for BMS-626529 include: - Ctrough (predose) |
predose and up to 12 hours post dose on Days 4, 16, 17, and 18 | |
Secondary | Other PK Parameters for maraviroc: Tmax | PK Parameters for maraviroc include: -Tmax |
predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18 | |
Secondary | Other PK Parameters for maraviroc: C12 | PK Parameters for maraviroc include: C12 |
predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18 | |
Secondary | Other PK Parameters for maraviroc: Ctrough | PK Parameters for maraviroc include: - Ctrough |
predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18 | |
Secondary | Clinical Safety as Measured by Adverse Events | Adverse event monitoring | Day 1 to Day 26 | |
Secondary | Clinical Safety as Measured by Vital Signs | Vital sign measurement | Day 1 to Day 26 | |
Secondary | Clinical Safety as Measured by Electrocardiograms (ECGs) | 12-lead ECGs | Day 1 to Day 26 | |
Secondary | Clinical Safety as Measured by Physical Examination | Physical examinations | Day 1 to Day 26 | |
Secondary | Clinical Safety as Measured by Clinical Laboratory Evaluations | Clinical chemistry, hematology, urinalysis | Day 1 to Day 26 |
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