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

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ViiV Healthcare

Status and phase

Completed
Phase 1

Conditions

Infection, Human Immunodeficiency Virus

Treatments

Drug: Maraviroc
Drug: BMS-663068

Study type

Interventional

Funder types

Industry

Identifiers

NCT02480894
AI438-052 (Other Identifier)
206278

Details and patient eligibility

About

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.

Enrollment

112 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

112 participants in 1 patient group

Sequential Dosing
Experimental group
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
Treatment:
Drug: BMS-663068
Drug: Maraviroc

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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