A Study to Evaluate the Effect of 2 Drugs on the Pharmacokinetics of BMS-986205 in Healthy Subjects

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Completed
Phase 1

Conditions

Malignancies Multiple

Treatments

Drug: Itraconazole
Drug: BMS-986205
Drug: Rifampin

Study type

Interventional

Funder types

Industry

Identifiers

NCT03346837
CA017-051

Details and patient eligibility

About

Assess the effects of itraconazole and rifampin on the pharmacokinetics, safety, and tolerability of BMS-986205.

Full description

A randomized, open-label, parallel design study in healthy participants to assess the effects of itraconazole and rifampin on the single-dose pharmacokinetics of BMS-986205. Safety and tolerability data to be collected and assessed as well.

Enrollment

53 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Body mass index 18.0 to 32.0 kg/m2, inclusive
  • Must have normal renal function demonstrated by GFR, calculated by Chronic Kidney Disease Epidemiology Collaboration formula
  • Women must not be of childbearing potential (cannot become pregnant)

Exclusion criteria

  • Any significant acute or chronic medical illness
  • History of glucose-6-phosphodiesterase (G6PD) deficiency
  • Personal or family history of cytochrome b5 reductase deficiency

Other protocol defined inclusion / exclusion criteria could apply

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

53 participants in 4 patient groups

Inhibition (Cohort 1)
Experimental group
Description:
Single oral dose BMS-986205
Treatment:
Drug: BMS-986205
Inhibition (Cohort 2)
Experimental group
Description:
Daily oral itraconazole doses for 24 days; single oral dose BMS-986205 on day 4
Treatment:
Drug: BMS-986205
Drug: Itraconazole
Induction (Cohort 3)
Experimental group
Description:
Single oral dose BMS-986205
Treatment:
Drug: BMS-986205
Induction (Cohort 4)
Experimental group
Description:
Daily oral rifampin doses for21 days; single oral dose BMS-986205 on day 8
Treatment:
Drug: Rifampin
Drug: BMS-986205

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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