Clinical trial NCT02480894: A Open-label, Drug-Drug Interaction With Maraviroc (DDI)
Official title: A Phase 1, Open-label, Drug-drug Interaction Study Between BMS-663068 and Maraviroc in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infection, Human Immunodeficiency Virus
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2015-06-25
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: BMS-626529 Pharmacokinetics: maximum observed plasma concentration (Cmax)
timeFrame: predose and up to 12 hours post dose on Days 4, 16, 17, and 18
measure: BMS-626529 Pharmacokinetics: area under the plasma concentration-time curve (AUC) in a single dosing interval AUC(TAU)
timeFrame: predose and up to 12 hours post dose on Days 4, 16, 17, and 18
measure: Maraviroc Pharmacokinetics: Cmax
timeFrame: predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18
measure: Maraviroc Pharmacokinetics: AUC(TAU)
timeFrame: predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18
Secondary outcomes:
measure: Other PK Parameters for BMS-626529: Time of maximum observed plasma concentration (Tmax)
timeFrame: predose and up to 12 hours post dose on Days 4, 16, 17, and 18
measure: Other PK Parameters for BMS-626529: plasma concentration observed at 12 hours post-dose (C12)
timeFrame: predose and up to 12 hours post dose on Days 4, 16, 17, and 18
measure: Other PK Parameters for BMS-626529: trough observed plasma concentration (Ctrough) (predose)
timeFrame: predose and up to 12 hours post dose on Days 4, 16, 17, and 18
measure: Other PK Parameters for maraviroc: Tmax
timeFrame: predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18
measure: Other PK Parameters for maraviroc: C12
timeFrame: predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18
measure: Other PK Parameters for maraviroc: Ctrough
timeFrame: predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18
measure: Clinical Safety as Measured by Adverse Events
timeFrame: Day 1 to Day 26
measure: Clinical Safety as Measured by Vital Signs
timeFrame: Day 1 to Day 26
measure: Clinical Safety as Measured by Electrocardiograms (ECGs)
timeFrame: Day 1 to Day 26
measure: Clinical Safety as Measured by Physical Examination
timeFrame: Day 1 to Day 26
measure: Clinical Safety as Measured by Clinical Laboratory Evaluations
timeFrame: Day 1 to Day 26
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
Study officials:
affiliation: ViiV Healthcare
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Wire MB, Magee M, Ackerman P, Llamoso C, Moore K. Evaluation of the pharmacokinetic drug-drug interaction between the antiretroviral agents fostemsavir and maraviroc: a single-sequence crossover study in healthy participants. HIV Res Clin Pract. 2021 Dec 9;23(1):1-8. Epub 2022 Mar 14.