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

NCT03634995 | Completed Phase 1 FDA Drug

• 2 other identifiers: IM026-0022017-003729-13
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (12)

• 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

Study Arms (3)

Single Dose

EXPERIMENTAL

Ascending single doses of BMS-986256

Drug: BMS-986256; Other: Placebo

Multiple Dose

EXPERIMENTAL

Ascending multiple doses of BMS-986256

Drug: BMS-986256; Other: Placebo

Sequential Dose

EXPERIMENTAL

Sequential multiple doses of BMS-986256

Drug: BMS-986256; Other: Placebo

Interventions

BMS-986256 DRUG

Specified dose on specified days

Multiple Dose; Sequential Dose; Single Dose

Placebo OTHER

Specified dose on specified days

Multiple Dose; Sequential Dose; Single Dose

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (2)

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

PRA Health Science KK

Lenexa, Kansas, 66219, United States

Location

Related Links

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

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: August 17, 2018
• Study Start: August 14, 2018
• Primary Completion: October 9, 2019
• Study Completion: October 9, 2019
• Last Updated: June 16, 2020

Record last verified: 2020-06

Locations

US (2)