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
Overview
- Phase
- Phase 1
- Intervention
- BMS-986256
- Conditions
- Healthy Participants
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 118
- Locations
- 2
- Primary Endpoint
- Number of clinically significant changes in ECG, vital signs, physical examination findings, or clinical laboratory assessments
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the effects of the experimental medication BMS-986256 in healthy participants.
Investigators
Eligibility Criteria
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
Arms & Interventions
Single Dose
Ascending single doses of BMS-986256
Intervention: BMS-986256
Single Dose
Ascending single doses of BMS-986256
Intervention: Placebo
Multiple Dose
Ascending multiple doses of BMS-986256
Intervention: BMS-986256
Multiple Dose
Ascending multiple doses of BMS-986256
Intervention: Placebo
Sequential Dose
Sequential multiple doses of BMS-986256
Intervention: BMS-986256
Sequential Dose
Sequential multiple doses of BMS-986256
Intervention: Placebo
Outcomes
Primary Outcomes
Number of clinically significant changes in ECG, vital signs, physical examination findings, or clinical laboratory assessments
Time Frame: Up to 44 days
Number of Adverse Events (AEs) leading to early discontinuation
Time Frame: Up to 44 days
Maximum concentration (Cmax)
Time Frame: Up to 44 days
Time of maximum concentration (Tmax)
Time Frame: Up to 44 days
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration [AUC(0-T)]
Time Frame: Up to 44 days
Area under the plasma concentration-time curve extrapolated to infinity [AUC(INF)]
Time Frame: Up to 44 days
Number of Serious Adverse Events (SAE)
Time Frame: Up to 46 days
Number of deaths
Time Frame: Up to 46 days
Secondary Outcomes
- Metabolite ratio for AUC(TAU) [MR(AUC[TAU])](Up to 44 days)
- 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)