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

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)

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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