A Open-label, Drug-Drug Interaction With Maraviroc (DDI)

Phase 1

Completed

• Conditions: Infection, Human Immunodeficiency Virus
• Interventions: Drug: BMS-663068; Drug: Maraviroc

• Registration Number: NCT02480894
• Lead Sponsor: ViiV Healthcare

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-16
• Study First Submitted QC: 2015-06-22
• Study First Posted: 2015-06-25
• Study Start: 2015-07-07
• Primary Completion: 2015-09-21
• Study Completion: 2015-09-21
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-20
• Last Update Posted: 2017-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sequential Dosing	Maraviroc	Treatment A: BMS-663068 orally twice daily (BID) on Days 1 through 4 Treatment B: Maraviroc BID on Days 7 through 11 Treatment C: BMS-663068 BID plus maraviroc BID on Days 12 through 18
Sequential Dosing	BMS-663068	Treatment A: BMS-663068 orally twice daily (BID) on Days 1 through 4 Treatment B: Maraviroc BID on Days 7 through 11 Treatment C: BMS-663068 BID plus maraviroc BID on Days 12 through 18

Primary Outcome Measures

Name	Time	Method
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
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: 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 Outcome Measures

Name	Time	Method
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 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 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
Clinical Safety as Measured by Vital Signs	Day 1 to Day 26	Vital sign measurement
Clinical Safety as Measured by Electrocardiograms (ECGs)	Day 1 to Day 26	12-lead ECGs
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 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

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 San Antonio, Texas, United States