A Study to Assess the Effect of Food on the Drug Levels of Admilparant

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Admilparant

Study type: Interventional

Funder types: Industry

Identifiers

NCT07225647

IM027-1052

Details and patient eligibility

About

The purpose of this study is to assess the effect of food on the drug levels of Admilparant

Enrollment: 56 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Participants must have a body mass index (BMI) of 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening.
• Participants must have a body weight of ≥ 50 kg for males and ≥ 45 kg for females at screening.

Exclusion Criteria

• Participants must not have any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
• Participants must not have had any previous exposure to Admilparant.
• Participants must not have a history of any severe drug allergy or drug reaction (such as anaphylaxis or hepatotoxicity).
• Other protocol-defined Inclusion/Exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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56 participants in 4 patient groups

Part 1: Treatment A

Experimental group

Treatment:

Drug: Admilparant

Part 1: Treatment B

Experimental group

Treatment:

Drug: Admilparant

Part 2: Treatment C

Experimental group

Treatment:

Drug: Admilparant

Part 2: Treatment D

Experimental group

Treatment:

Drug: Admilparant