A Pharmacokinetics, Safety and Tolerability Study of Multiple Formulations of BMS-986231 in Healthy Participants

NCT ID: NCT03891108

Last Updated: 2019-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-28
• Study Completion Date: 2019-07-29

Brief Summary

Main Objective of this study is to compare the single intravenous (IV) infusion pharmacokinetics (PK) of BMS-986231 and its metabolites (BMT-284730, BMT-279554, and CAR-000463) following of up to 2 test formulations of BMS-986231 relative to the reference formulation.

Detailed Description

Participants will be randomized 1:1:1:1 and dosed with either of the 4 treatments: A, B, C, or D; followed by review of safety and tolerability data during and after the infusion. The study will proceed with treatments A, and C unless one or more of these treatments shows poor tolerability; in which case the study may proceed with treatment B or D in the follow-up cohorts. Additional participants will be randomized equally to each of the treatments the study will proceed with.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment A: BMS-986231 Formulation A

Participants will be administered Treatment A: BMS-986231 Formulation A as a 48-hour IV infusion on Day 1, followed by review of safety and tolerability data during and after the infusion.

Group Type: ACTIVE_COMPARATOR

BMS-986231 Formulation A

Intervention Type: DRUG

Participants will be administered BMS-986231 Formulation A as IV infusion for 48 hours.

Treatment B: BMS-986231 Formulation B

Participants will be administered Treatment B: BMS-986231 Formulation B as a 48-hour IV infusion on Day 1, followed by review of safety and tolerability data during and after the infusion.

Group Type: EXPERIMENTAL

BMS-986231 Formulation B

Intervention Type: DRUG

Participants will be administered BMS-986231 Formulation B as IV infusion for 48 hours.

Treatment C: BMS-986231 Formulation C

Participants will be administered Treatment C: BMS-986231 Formulation C as a 48-hour IV infusion on Day 1, followed by review of safety and tolerability data during and after the infusion.

Group Type: EXPERIMENTAL

BMS-986231 Formulation C

Intervention Type: DRUG

Participants will be administered BMS-986231 Formulation C as IV infusion for 48 hours.

Treatment D: BMS 986231 Formulation D

Participants will be administered Treatment D: BMS 986231 Formulation D as a 48-hour IV infusion on Day 1, followed by review of safety and tolerability data during and after the infusion.

Group Type: EXPERIMENTAL

BMS-986231 Formulation D

Intervention Type: DRUG

Participants will be administered BMS-986231 Formulation D as IV infusion for 48 hours.

Interventions

BMS-986231 Formulation A

Participants will be administered BMS-986231 Formulation A as IV infusion for 48 hours.

Intervention Type: DRUG

BMS-986231 Formulation B

Participants will be administered BMS-986231 Formulation B as IV infusion for 48 hours.

Intervention Type: DRUG

BMS-986231 Formulation C

Participants will be administered BMS-986231 Formulation C as IV infusion for 48 hours.

Intervention Type: DRUG

BMS-986231 Formulation D

Participants will be administered BMS-986231 Formulation D as IV infusion for 48 hours.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participants must be willing to participate in the study and sign the informed consent form (ICF).
• Participants must be willing and able to complete all study-specific procedures and visits.
• Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations in the opinion of the investigator.
• Body mass index of 18.0 to 32.0 kg/m2, inclusive, and body weight ≥ 45 kg and ≤ 110 kg, at screening.
• Heart rate > 45 bpm and < 95 bpm at screening or baseline (within 30 minutes prior to randomization).
• Systolic BP > 110 mmHg and < 140 mmHg at screening or baseline (within 30 minutes prior to randomization).
• Normal renal function at screening as evidenced by an estimated glomerular filtration rate > 80 mL/min/1.732 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula.
• Males and females, ages 18 or local age of majority to 40 years, inclusive.

Exclusion Criteria

• Any significant acute or chronic medical illness
• Diagnosis of fibromyalgia
• History of syncope, orthostatic instability, or recurrent dizziness
• History or family history of ocular disorders (eg, glaucoma)
• History of bleeding diathesis (unusual susceptibility to bleed [hemorrhage] mostly due to hypocoagulability)
• Personal history or strong family history of sudden cardiac death, myocardial infarction, or other heart disease considered to be clinically significant by the investigator
• Any major surgery within 4 weeks of study drug administration
• History of Gilbert's Syndrome

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

PRA Health Sciences

Salt Lake City, Utah, United States

Countries

United States

Related Links

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.bmsstudyconnect.com/s/US/English/USenHome

BMS Clinical Trial Patient Recruiting

https://www.bms.com/researchers-and-partners/investigator-inquiry-form.html

Investigator Inquiry Form

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

CV013-038

Identifier Type: -

Identifier Source: org_study_id