Healthy Participants
Conditions
Brief summary
The purpose of this study is to evaluate the effects of the experimental medication BMS-986256 in healthy participants.
Interventions
DRUGBMS-986256
Specified dose on specified days
OTHERPlacebo
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
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/
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| Accumulation ratio of Ctrough [AR(Ctrough)] | Up to 44 days |
| Accumulation ratio of AUC(TAU) [AR(AUC[TAU])] | Up to 44 days |
| Terminal elimination rate constant (kel) | Up to 44 days |
| Metabolite ratio for AUC(TAU) [MR(AUC[TAU])] | Up to 44 days |
| Accumulation ratio of Cmax [AR(Cmax)] | 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 |
Countries
United States
Outcome results
None listed