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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03634995
• Collaborator: (none)
• Enrollment: 118
• Locations: 2
• Arms: 3
• Actual Duration (Months): 13.8
• Patients Per Site: 59
• Patients Per Site Per Month: 4.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Participants	Drug: BMS-986256; Other: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 118 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Aug 14, 2018
• Actual Primary Completion Date: Oct 9, 2019
• Actual Study Completion Date: Oct 9, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single Dose Ascending single doses of BMS-986256	Drug: BMS-986256; Specified dose on specified days; Other: Placebo; Specified dose on specified days
Experimental: Multiple Dose Ascending multiple doses of BMS-986256	Drug: BMS-986256; Specified dose on specified days; Other: Placebo; Specified dose on specified days
Experimental: Sequential Dose Sequential multiple doses of BMS-986256	Drug: BMS-986256; Specified dose on specified days; Other: Placebo; Specified dose on specified days

Outcome Measures

Primary Outcome Measures

1. Number of Serious Adverse Events (SAE) [Up to 46 days]

2. Number of deaths [Up to 46 days]

3. Number of clinically significant changes in ECG, vital signs, physical examination findings, or clinical laboratory assessments [Up to 44 days]

4. Number of Adverse Events (AEs) leading to early discontinuation [Up to 44 days]

5. Maximum concentration (Cmax) [Up to 44 days]

6. Time of maximum concentration (Tmax) [Up to 44 days]

7. Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration [AUC(0-T)] [Up to 44 days]

8. Area under the plasma concentration-time curve extrapolated to infinity [AUC(INF)] [Up to 44 days]

Secondary Outcome Measures

1. Terminal elimination rate constant (kel) [Up to 44 days]

2. Terminal elimination half-life (T-half) [Up to 44 days]

3. Apparent oral clearance (CL/F) [Up to 44 days]

4. Metabolite ratio for AUC(INF) [MR(AUC[INF])] [Up to 44 days]

5. Metabolite ratio of Cmax [MR(Cmax)] [Up to 44 days]

6. Apparent volume of distribution at terminal phase (Vz/F) [Up to 44 days]

7. Plasma concentration immediately prior to dosing (Ctrough) [Up to 44 days]

8. Area under the plasma concentration-time curve over the dosing interval [AUC(TAU)] [Up to 44 days]

9. Accumulation ratio of Ctrough [AR(Ctrough)] [Up to 44 days]

10. Accumulation ratio of AUC(TAU) [AR(AUC[TAU])] [Up to 44 days]

11. Accumulation ratio of Cmax [AR(Cmax)] [Up to 44 days]

12. Metabolite ratio for AUC(TAU) [MR(AUC[TAU])] [Up to 44 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anaheim Clinical Trials	Anaheim	California	United States	92801
2	PRA Health Science KK	Lenexa	Kansas	United States	66219

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT03634995
• Other Study ID Numbers: IM026-002; 2017-003729-13
• First Posted: Aug 17, 2018
• Last Update Posted: Jun 16, 2020
• Last Verified: Jun 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 16, 2020