Single and Multiple Dose Pharmacokinetics of BMS-986165 in a Randomized, Double-Blind, Placebo-Controlled Study in Healthy Chinese Subjects

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Autoimmune Diseases

Treatments: Drug: BMS-986165; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03956953

IM011-053

Details and patient eligibility

About

Main objective of this study is to assess BMS-986165 plasma PK following single and multiple oral doses of BMS-986165 in healthy Chinese subjects.

Enrollment: 135 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Signed Informed Consent.
• Healthy participants, as determined by physical examination, ECGs, and clinical laboratory and procedure determinations.
• Body mass index (BMI) of 18 to 24 kg/m2, inclusive, and total body weight >= 50 kg.

Exclusion criteria

• History of allergy to drug class or related compounds.
• History or evidence of active infection within 7 days of study day 1.
• Drug or alcohol abuse within 6 months of study treatment administration.

Other protocol defined inclusion/exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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135 participants in 4 patient groups, including a placebo group

Group 1: BMS-986165 Dose 1

Experimental group

Description:

Participants will receive Dose 1 on Day 1, and from Day 5 - 19.

Treatment:

Drug: BMS-986165

Group 2: BMS-986165 Dose 2

Experimental group

Description:

Participants will receive Dose 2 on Day 1, and from Day 5 - 19.

Treatment:

Drug: BMS-986165

Group 1: Placebo Dose 1

Placebo Comparator group

Description:

Participants will receive placebo matching Dose 1 on Day 1, and from Day 5 - 19.

Treatment:

Other: Placebo

Group 2: Placebo Dose 2

Placebo Comparator group

Description:

Participants will receive placebo matching Dose 2 on Day 1, and from Day 5 - 19.

Treatment:

Other: Placebo