An Investigational Study to Evaluate the Effects of Experimental Medication BMS-986256 in Healthy Participants

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03634995
• Other study ID #: IM026-002
• Secondary ID: 2017-003729-13
• Status: Completed
• Phase: Phase 1
• Start date: August 14, 2018
• Est. completion date: October 9, 2019

Study information

• Verified date: June 2020
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: October 9, 2019
• Est. primary completion date: October 9, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• BMS-986256
Specified dose on specified days

Other:
• Placebo
Specified dose on specified days

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials	Anaheim	California
United States	PRA Health Science KK	Lenexa	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Serious Adverse Events (SAE)		Up to 46 days
Primary	Number of deaths		Up to 46 days
Primary	Number of clinically significant changes in ECG, vital signs, physical examination findings, or clinical laboratory assessments		Up to 44 days
Primary	Number of Adverse Events (AEs) leading to early discontinuation		Up to 44 days
Primary	Maximum concentration (Cmax)		Up to 44 days
Primary	Time of maximum concentration (Tmax)		Up to 44 days
Primary	Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration [AUC(0-T)]		Up to 44 days
Primary	Area under the plasma concentration-time curve extrapolated to infinity [AUC(INF)]		Up to 44 days
Secondary	Terminal elimination rate constant (kel)		Up to 44 days
Secondary	Terminal elimination half-life (T-half)		Up to 44 days
Secondary	Apparent oral clearance (CL/F)		Up to 44 days
Secondary	Metabolite ratio for AUC(INF) [MR(AUC[INF])]		Up to 44 days
Secondary	Metabolite ratio of Cmax [MR(Cmax)]		Up to 44 days
Secondary	Apparent volume of distribution at terminal phase (Vz/F)		Up to 44 days
Secondary	Plasma concentration immediately prior to dosing (Ctrough)		Up to 44 days
Secondary	Area under the plasma concentration-time curve over the dosing interval [AUC(TAU)]		Up to 44 days
Secondary	Accumulation ratio of Ctrough [AR(Ctrough)]		Up to 44 days
Secondary	Accumulation ratio of AUC(TAU) [AR(AUC[TAU])]		Up to 44 days
Secondary	Accumulation ratio of Cmax [AR(Cmax)]		Up to 44 days
Secondary	Metabolite ratio for AUC(TAU) [MR(AUC[TAU])]		Up to 44 days

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form