A Study of the Pharmacokinetic Interaction Between Pirfenidone and BMS-986278 in Healthy Participants

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Idiopathic Pulmonary Fibrosis (IPF)

Treatments: Drug: BMS-986278; Drug: Pirfenidone

Study type: Interventional

Funder types: Industry

Identifiers

NCT03981094

IM027-041

Details and patient eligibility

About

The main objectives of this study are to characterize the PK of BMS-986278 after administration of a single dose of BMS-986278 alone or in combination with pirfenidone, as well as to characterize the PK of pirfenidone after administration of a single dose of pirfenidone alone or in combination with BMS-986278

Enrollment: 22 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Signed Informed Consent.
• Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.

Exclusion criteria

• Women of child bearing potentia (WOCBP), pregnant or breastfeeding.
• History of significant cardiovascular disease.
• Participants who have smoked or used smoking cessation or nicotine containing products within 3 months of the first dose of study.

Other protocol defined inclusion/exclusion criteria could apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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22 participants in 3 patient groups

BMS-986278

Experimental group

Treatment:

Drug: BMS-986278

Pirfenidone

Experimental group

Treatment:

Drug: Pirfenidone

BMS-986278 + Pirfenidone

Experimental group

Treatment:

Drug: Pirfenidone

Drug: BMS-986278