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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-04

Study Completion Date

2019-09-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Autoimmune Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

There will be two dose groups. Once the safety and tolerability up to discharge (Day 24) of Group 1, has been assessed and deemed safe; dosing for Group 2 will begin.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group 1: BMS-986165 Dose 1

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

Group Type EXPERIMENTAL

BMS-986165

Intervention Type DRUG

Dose 1 or Dose 2 on Day 1, and from Days 5-19'

Group 2: BMS-986165 Dose 2

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

Group Type EXPERIMENTAL

BMS-986165

Intervention Type DRUG

Dose 1 or Dose 2 on Day 1, and from Days 5-19'

Group 1: Placebo Dose 1

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo matching Dose 1 or Dose 2 on Day 1, and from Days 5-19

Group 2: Placebo Dose 2

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo matching Dose 1 or Dose 2 on Day 1, and from Days 5-19

Interventions

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BMS-986165

Dose 1 or Dose 2 on Day 1, and from Days 5-19'

Intervention Type DRUG

Placebo

Placebo matching Dose 1 or Dose 2 on Day 1, and from Days 5-19

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes