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

Primary Purpose

Infection, Human Immunodeficiency Virus

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-663068
Maraviroc
Sponsored by
ViiV Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infection, Human Immunodeficiency Virus

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • GSK Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sequential Dosing

Arm Description

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

Outcomes

Primary Outcome Measures

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
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)
Maraviroc Pharmacokinetics: Cmax
PK parameters for maraviroc in the absence or presence of BMS-663068 include: - Cmax
Maraviroc Pharmacokinetics: AUC(TAU)
PK parameters for maraviroc in the absence or presence of BMS-663068 include: - AUC(TAU)

Secondary Outcome Measures

Other PK Parameters for BMS-626529: Time of maximum observed plasma concentration (Tmax)
PK parameters for BMS-626529 include: - Tmax
Other PK Parameters for BMS-626529: plasma concentration observed at 12 hours post-dose (C12)
PK parameters for BMS-626529 include: - C12
Other PK Parameters for BMS-626529: trough observed plasma concentration (Ctrough) (predose)
PK parameters for BMS-626529 include: - Ctrough (predose)
Other PK Parameters for maraviroc: Tmax
PK Parameters for maraviroc include: -Tmax
Other PK Parameters for maraviroc: C12
PK Parameters for maraviroc include: C12
Other PK Parameters for maraviroc: Ctrough
PK Parameters for maraviroc include: - Ctrough
Clinical Safety as Measured by Adverse Events
Adverse event monitoring
Clinical Safety as Measured by Vital Signs
Vital sign measurement
Clinical Safety as Measured by Electrocardiograms (ECGs)
12-lead ECGs
Clinical Safety as Measured by Physical Examination
Physical examinations
Clinical Safety as Measured by Clinical Laboratory Evaluations
Clinical chemistry, hematology, urinalysis

Full Information

First Posted
June 16, 2015
Last Updated
September 20, 2017
Sponsor
ViiV Healthcare
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT02480894
Brief Title
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

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
July 7, 2015 (Actual)
Primary Completion Date
September 21, 2015 (Actual)
Study Completion Date
September 21, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ViiV Healthcare
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Human Immunodeficiency Virus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sequential Dosing
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
BMS-663068
Intervention Description
BMS-663068
Intervention Type
Drug
Intervention Name(s)
Maraviroc
Intervention Description
Maraviroc
Primary Outcome Measure Information:
Title
BMS-626529 Pharmacokinetics: maximum observed plasma concentration (Cmax)
Description
PK parameters for BMS-626529 in the absence or presence of multiple doses of maraviroc include: - Cmax
Time Frame
predose and up to 12 hours post dose on Days 4, 16, 17, and 18
Title
BMS-626529 Pharmacokinetics: area under the plasma concentration-time curve (AUC) in a single dosing interval AUC(TAU)
Description
PK parameters for BMS-626529 in the absence or presence of multiple doses of maraviroc include: - AUC(TAU)
Time Frame
predose and up to 12 hours post dose on Days 4, 16, 17, and 18
Title
Maraviroc Pharmacokinetics: Cmax
Description
PK parameters for maraviroc in the absence or presence of BMS-663068 include: - Cmax
Time Frame
predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18
Title
Maraviroc Pharmacokinetics: AUC(TAU)
Description
PK parameters for maraviroc in the absence or presence of BMS-663068 include: - AUC(TAU)
Time Frame
predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18
Secondary Outcome Measure Information:
Title
Other PK Parameters for BMS-626529: Time of maximum observed plasma concentration (Tmax)
Description
PK parameters for BMS-626529 include: - Tmax
Time Frame
predose and up to 12 hours post dose on Days 4, 16, 17, and 18
Title
Other PK Parameters for BMS-626529: plasma concentration observed at 12 hours post-dose (C12)
Description
PK parameters for BMS-626529 include: - C12
Time Frame
predose and up to 12 hours post dose on Days 4, 16, 17, and 18
Title
Other PK Parameters for BMS-626529: trough observed plasma concentration (Ctrough) (predose)
Description
PK parameters for BMS-626529 include: - Ctrough (predose)
Time Frame
predose and up to 12 hours post dose on Days 4, 16, 17, and 18
Title
Other PK Parameters for maraviroc: Tmax
Description
PK Parameters for maraviroc include: -Tmax
Time Frame
predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18
Title
Other PK Parameters for maraviroc: C12
Description
PK Parameters for maraviroc include: C12
Time Frame
predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18
Title
Other PK Parameters for maraviroc: Ctrough
Description
PK Parameters for maraviroc include: - Ctrough
Time Frame
predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18
Title
Clinical Safety as Measured by Adverse Events
Description
Adverse event monitoring
Time Frame
Day 1 to Day 26
Title
Clinical Safety as Measured by Vital Signs
Description
Vital sign measurement
Time Frame
Day 1 to Day 26
Title
Clinical Safety as Measured by Electrocardiograms (ECGs)
Description
12-lead ECGs
Time Frame
Day 1 to Day 26
Title
Clinical Safety as Measured by Physical Examination
Description
Physical examinations
Time Frame
Day 1 to Day 26
Title
Clinical Safety as Measured by Clinical Laboratory Evaluations
Description
Clinical chemistry, hematology, urinalysis
Time Frame
Day 1 to Day 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
ViiV Healthcare
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35285786
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.
Results Reference
derived

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

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