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

NCT02480894 | Completed Phase 1

• 2 other identifiers: 206278AI438-052
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection, Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (11)

• 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

• 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

• 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

• Other PK Parameters for maraviroc: Tmax

  predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18

• Other PK Parameters for maraviroc: C12

  predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18

Study Arms (1)

Sequential Dosing

EXPERIMENTAL

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

Drug: BMS-663068; Drug: Maraviroc

Interventions

BMS-663068 DRUG

BMS-663068

Sequential Dosing

Maraviroc DRUG

Maraviroc

Sequential Dosing

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Any condition possibly affecting drug absorption
• Pre-existing liver dysfunction
• Any significant acute or chronic medical illness
• Orthostatic intolerance

Sponsors & Collaborators

• ViiV Healthcare: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

GSK Investigational Site

San Antonio, Texas, 78209, United States

Location

Related Publications (1)

• 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.

  PMID: 35285786 DERIVED

MeSH Terms

Conditions

Infections; Acquired Immunodeficiency Syndrome

Interventions

fostemsavir; Maraviroc

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• GSK Clinical Trials

  ViiV Healthcare

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2015
• First Posted: June 25, 2015
• Study Start: July 7, 2015
• Primary Completion: September 21, 2015
• Study Completion: September 21, 2015
• Last Updated: September 25, 2017

Record last verified: 2017-09

Locations

US (1)