NCT04882150

Brief Summary

The purpose of this study is to characterize the safety, tolerability, drug levels and drug effects of BMS-986196 in healthy participants. In addition, an evaluation of food and formulation effects on BMS-986196 absorption will be performed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 11, 2021

Completed
16 days until next milestone

Study Start

First participant enrolled

May 27, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2022

Completed
Last Updated

January 12, 2023

Status Verified

January 1, 2023

Enrollment Period

1 year

First QC Date

May 6, 2021

Last Update Submit

January 11, 2023

Conditions

Healthy Participants

Keywords

Healthy participantsBMS-986196

Outcome Measures

Primary Outcomes (18)

  • Incidence of Adverse Events (AEs)

    Up to 24 days

  • Severity of AEs

    Up to 24 days

  • Causality of AEs

    Up to 24 days

  • Incidence of Serious Adverse Events (SAEs)

    Up to 59 days

  • Severity of SAEs

    Up to 59 days

  • Causality of SAEs

    Up to 59 days

  • Incidence of clinically significant changes in vital signs: Body temperature

    Up to 24 days

  • Incidence of clinically significant changes in vital signs: Respiratory rate

    Up to 24 days

  • Incidence of clinically significant changes in vital signs: Blood pressure

    Up to 24 days

  • Incidence of clinically significant changes in vital signs: Heart rate

    Up to 24 days

  • Incidence of clinically significant changes in weight

    Up to 24 days

  • Incidence of clinically significant changes in physical examination

    Up to 24 days

  • Incidence of clinically significant changes in ECG parameters: QT interval

    Up to 24 days

  • Incidence of clinically significant changes in ECG parameters: HR

    Up to 24 days

  • Incidence of clinically significant changes in clinical laboratory values: Hematology tests

    Up to 24 days

  • Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests

    Up to 24 days

  • Incidence of clinically significant changes in clinical laboratory values: Coagulation tests

    Up to 24 days

  • Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests

    Up to 24 days

Study Arms (3)

Part A: SAD

EXPERIMENTAL

SAD = single ascending dose. Each participant will receive a single dose of BMS-986196 or placebo.

Drug: BMS-986196Other: Placebo

Part B: MAD

EXPERIMENTAL

MAD = multiple ascending dose. Each participant will receive multiple doses of BMS-986196 or placebo.

Drug: BMS-986196Other: Placebo

Part C: FE/Formul.

EXPERIMENTAL

FE/Formul. = food and formulation effects and relative absorption. Participants will receive two formulations of BMS-986196 (solution and suspension), each formulation with and without food.

Drug: BMS-986196

Interventions

BMS-986196DRUG

Specified dose on specified days

Part A: SADPart B: MADPart C: FE/Formul.
PlaceboOTHER

Specified dose on specified days

Part A: SADPart B: MAD

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women not of childbearing potential and men, ages 18 or local age of majority to 55 years, inclusive
  • Healthy male and female non-Japanese participants without clinically significant deviation from normal in medical history, physical examination, electrocardiogram (ECG), and clinical laboratory determinations
  • Body mass index (BMI) of 18 to 32 kg/m2, inclusive, and total body weight ≥ 50 kg

You may not qualify if:

  • Known or suspected autoimmune disorder, including but not limited to rheumatoid arthritis, fibromyalgia, systemic lupus erythematosus, polymyalgia rheumatica, giant cell arteritis, Behcet's disease, dermatomyositis, MS, moderate to severe asthma, any autoimmune vasculitis, autoimmune hepatitis, or any other active autoimmune disease for which a participant requires medical follow-up or medical treatment
  • Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status
  • Presence of any factors that would predispose the participant to develop infection
  • A history of bacterial or fungal meningitis within 1 year prior to screening
  • A history of intracranial or intraspinal bleeding
  • Known intracranial space-occupying mass, including meningioma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution - 0002

Salt Lake City, Utah, 84124, United States

Location

Related Links

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2021

First Posted

May 11, 2021

Study Start

May 27, 2021

Primary Completion

June 10, 2022

Study Completion

June 10, 2022

Last Updated

January 12, 2023

Record last verified: 2023-01

Locations

US(1)