An Investigational Study to Evaluate the Effects of Experimental Medication BMS-986256 in Healthy Participants

A Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunologic Effects of BMS-986256, and a Relative Bioavailability Study in Healthy Participants

The purpose of this study is to evaluate the effects of the experimental medication BMS-986256 in healthy participants.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Other: Placebo; Drug: BMS-986256

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • PRA Health Science KK

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Weight ≥ 50 kg and body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive at screening
• Participants must not be current users (within 6 months before screening) of tobacco or tobacco- or nicotine-containing products; they must also be willing to refrain from using any of these products during their participation in the study
• A negative QuantiFERON®-TB Gold test result at screening or documentation of a negative result within 3 months before screening

Exclusion Criteria:

• Previous participation in the current study or previous exposure within 6 weeks before study drug administration for non-biologics and 12 weeks before study drug administration for biologics
• Inability to tolerate oral medication
• Inability to tolerate venipuncture, or inadequate venous access

Other protocol defined inclusion/exclusion criteria could apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Dose; Ascending single doses of BMS-986256	Other: Placebo; Specified dose on specified days; Drug: BMS-986256; Specified dose on specified days
Experimental: Multiple Dose; Ascending multiple doses of BMS-986256	Other: Placebo; Specified dose on specified days; Drug: BMS-986256; Specified dose on specified days
Experimental: Sequential Dose; Sequential multiple doses of BMS-986256	Other: Placebo; Specified dose on specified days; Drug: BMS-986256; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Serious Adverse Events (SAE)	Up to 46 days
Number of deaths	Up to 46 days
Number of clinically significant changes in ECG, vital signs, physical examination findings, or clinical laboratory assessments	Up to 44 days
Number of Adverse Events (AEs) leading to early discontinuation	Up to 44 days
Maximum concentration (Cmax)	Up to 44 days
Time of maximum concentration (Tmax)	Up to 44 days
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration [AUC(0-T)]	Up to 44 days
Area under the plasma concentration-time curve extrapolated to infinity [AUC(INF)]	Up to 44 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Terminal elimination rate constant (kel)	Up to 44 days
Terminal elimination half-life (T-half)	Up to 44 days
Apparent oral clearance (CL/F)	Up to 44 days
Metabolite ratio for AUC(INF) [MR(AUC[INF])]	Up to 44 days
Metabolite ratio of Cmax [MR(Cmax)]	Up to 44 days
Apparent volume of distribution at terminal phase (Vz/F)	Up to 44 days
Plasma concentration immediately prior to dosing (Ctrough)	Up to 44 days
Area under the plasma concentration-time curve over the dosing interval [AUC(TAU)]	Up to 44 days
Accumulation ratio of Ctrough [AR(Ctrough)]	Up to 44 days
Accumulation ratio of AUC(TAU) [AR(AUC[TAU])]	Up to 44 days
Accumulation ratio of Cmax [AR(Cmax)]	Up to 44 days
Metabolite ratio for AUC(TAU) [MR(AUC[TAU])]	Up to 44 days

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2018
• Primary Completion (Actual): October 9, 2019
• Study Completion (Actual): October 9, 2019

Study Registration Dates

• First Submitted: August 15, 2018
• First Submitted That Met QC Criteria: August 15, 2018
• First Posted (Actual): August 17, 2018

Study Record Updates

• Last Update Posted (Actual): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 11, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: IM026-002; 2017-003729-13 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No