An Investigational Study to Evaluate the Effects of Experimental Medication BMS-986256 in Healthy Participants
- Registration Number
- NCT03634995
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to evaluate the effects of the experimental medication BMS-986256 in healthy participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 118
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Multiple Dose Placebo Ascending multiple doses of BMS-986256 Single Dose Placebo Ascending single doses of BMS-986256 Sequential Dose Placebo Sequential multiple doses of BMS-986256 Single Dose BMS-986256 Ascending single doses of BMS-986256 Multiple Dose BMS-986256 Ascending multiple doses of BMS-986256 Sequential Dose BMS-986256 Sequential multiple doses of BMS-986256
- Primary Outcome Measures
Name Time Method 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 Number of Serious Adverse Events (SAE) Up to 46 days Number of deaths Up to 46 days
- Secondary Outcome Measures
Name Time Method 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 Accumulation ratio of Ctrough [AR(Ctrough)] 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
Trial Locations
- Locations (2)
Anaheim Clinical Trials
🇺🇸Anaheim, California, United States
PRA Health Science KK
🇺🇸Lenexa, Kansas, United States