Clinical trial NCT03634995: An Investigational Study to Evaluate the Effects of Experimental Medication BMS-986256 in Healthy Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-08-17
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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/exclusion criteria could apply

Primary outcomes:
measure: Number of Serious Adverse Events (SAE)
timeFrame: Up to 46 days
measure: Number of deaths
timeFrame: Up to 46 days
measure: Number of clinically significant changes in ECG, vital signs, physical examination findings, or clinical laboratory assessments
timeFrame: Up to 44 days
measure: Number of Adverse Events (AEs) leading to early discontinuation
timeFrame: Up to 44 days
measure: Maximum concentration (Cmax)
timeFrame: Up to 44 days
measure: Time of maximum concentration (Tmax)
timeFrame: Up to 44 days
measure: Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration [AUC(0-T)]
timeFrame: Up to 44 days
measure: Area under the plasma concentration-time curve extrapolated to infinity [AUC(INF)]
timeFrame: Up to 44 days
Secondary outcomes:
measure: Terminal elimination rate constant (kel)
timeFrame: Up to 44 days
measure: Terminal elimination half-life (T-half)
timeFrame: Up to 44 days
measure: Apparent oral clearance (CL/F)
timeFrame: Up to 44 days
measure: Metabolite ratio for AUC(INF) [MR(AUC[INF])]
timeFrame: Up to 44 days
measure: Metabolite ratio of Cmax [MR(Cmax)]
timeFrame: Up to 44 days
measure: Apparent volume of distribution at terminal phase (Vz/F)
timeFrame: Up to 44 days
measure: Plasma concentration immediately prior to dosing (Ctrough)
timeFrame: Up to 44 days
measure: Area under the plasma concentration-time curve over the dosing interval [AUC(TAU)]
timeFrame: Up to 44 days
measure: Accumulation ratio of Ctrough [AR(Ctrough)]
timeFrame: Up to 44 days
measure: Accumulation ratio of AUC(TAU) [AR(AUC[TAU])]
timeFrame: Up to 44 days
measure: Accumulation ratio of Cmax [AR(Cmax)]
timeFrame: Up to 44 days
measure: Metabolite ratio for AUC(TAU) [MR(AUC[TAU])]
timeFrame: Up to 44 days
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
city: Lenexa
country: United States
facility: PRA Health Science KK
state: Kansas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: