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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02480894
• Other study ID #: 206278
• Secondary ID: AI438-052
• Status: Completed
• Phase: Phase 1
• First received: June 16, 2015
• Last updated: September 20, 2017
• Start date: July 7, 2015
• Est. completion date: September 21, 2015

Study information

• Verified date: September 2017
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Immunologic Deficiency Syndromes
• Infection, Human Immunodeficiency Virus

Intervention

Drug:
• BMS-663068
BMS-663068
• Maraviroc
Maraviroc

Locations

Country	Name	City	State
United States	GSK Investigational Site	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
ViiV Healthcare	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

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