BMS-986256
DrugSpecified dose on specified days
Completed
NCT Number: NCT03634995
An Investigational Study to Evaluate the Effects of Experimental Medication BMS-986256 in Healthy Participants
The purpose of this study is to evaluate the effects of the experimental medication BMS-986256 in healthy participants.
Completed
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Notify MeKey information
Conditions
Age range
18 year–55 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Anaheim Clinical Trials, Anaheim, California, United States
Loading trial locations.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Placebo
OtherSpecified dose on specified days
Primary outcomes
-
Number of Serious Adverse Events (SAE)
Time frame: Up to 46 days
-
Number of deaths
Time frame: Up to 46 days
-
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
Secondary outcomes
-
Terminal elimination rate constant (kel)
Time frame: Up to 44 days
-
Terminal elimination half-life (T-half)
Time frame: Up to 44 days
-
Apparent oral clearance (CL/F)
Time frame: Up to 44 days
-
Metabolite ratio for AUC(INF) [MR(AUC[INF])]
Time frame: Up to 44 days
-
Metabolite ratio of Cmax [MR(Cmax)]
Time frame: Up to 44 days
-
Apparent volume of distribution at terminal phase (Vz/F)
Time frame: Up to 44 days
-
Plasma concentration immediately prior to dosing (Ctrough)
Time frame: Up to 44 days
-
Area under the plasma concentration-time curve over the dosing interval [AUC(TAU)]
Time frame: Up to 44 days
-
Accumulation ratio of Ctrough [AR(Ctrough)]
Time frame: Up to 44 days
-
Accumulation ratio of AUC(TAU) [AR(AUC[TAU])]
Time frame: Up to 44 days
-
Accumulation ratio of Cmax [AR(Cmax)]
Time frame: Up to 44 days
-
Metabolite ratio for AUC(TAU) [MR(AUC[TAU])]
Time frame: Up to 44 days
Sponsors and collaborators
Lead sponsor
Bristol-Myers Squibb
Industry
Registry information
Official study 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
Important dates
- Study start
- 2018
- Primary completion
- 2019
- Study completion
- 2019
- First posted
- Aug 17, 2018
- Registry last updated
- Jun 16, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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