Pharmacokinetics (Drug Levels in Blood) of BMS-986165 When Taken as Various Solid Tablet Prototypes by Healthy Participants

A Study to Evaluate the Pharmacokinetics of BMS-986165 Administered as Various Prototypic Solid Tablet Formulations in Healthy Subjects

The purpose of this study is to characterize the pharmacokinetics (the way the body absorbs, distributes and eliminates the drug) of BMS 986165 given in the form of various prototypes of solid tablets to healthy participants.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: BMS-986165; Drug: BMS-986165 prototype 1; Drug: BMS-986165 prototype 2

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33126
      • Quotient Sciences Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• In the opinion of the investigator, a healthy participant is determined by having no clinically significant deviation from normal in medical history, physical examination,electrocardiograms, vital signs, and clinical laboratory determinations.
• Body weight >= 50 kg at screening
• Women and men must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

• Any major surgery, per investigator's discretion, within 4 weeks of study drug administration
• Inability to tolerate oral medication
• History of allergy to BMS-986165 or related compounds

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment A : BMS-986165	Drug: BMS-986165; Specified dose on specified days
EXPERIMENTAL: Treatment B: BMS-986165 prototype 1	Drug: BMS-986165 prototype 1; Specified dose on specified days
EXPERIMENTAL: Treatment C: BMS-986165 prototype 2	Drug: BMS-986165 prototype 2; Specified dose on specified days
EXPERIMENTAL: Treatment D: BMS-986165 prototype 2	Drug: BMS-986165 prototype 2; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum concentration (Cmax) for BMS-986165 in plasma	Up to 18 days
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-T)) for BMS-986165 in plasma	Up to 18 days
Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) for BMS-986165 in plasma	Up to 18 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of Serious Adverse Events (SAEs)	Up to 55 days
Incidence of Adverse Events (AEs)	Up to 23 days
Number of clinically significant abnormalities in electrocardiogram (ECG) parameters	Up to 50 days
Number of participants with vital sign abnormalities in body temperature	Up to 50 days
Number of participants with vital sign abnormalities in respiratory rate	Up to 50 days
Number of participants with vital sign abnormalities in heart rate	Up to 50 days
Number of participants with vital sign abnormalities in blood pressure	Up to 50 days
Number of participants with clinical laboratory test abnormalities: Hematology tests	Up to 50 days
Number of participants with clinical laboratory test abnormalities: Clinical chemistry tests	Up to 50 days
Number of participants with clinical laboratory test abnormalities: Urinalysis tests	Up to 50 days

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 6, 2020
• Primary Completion (ACTUAL): March 15, 2020
• Study Completion (ACTUAL): March 15, 2020

Study Registration Dates

• First Submitted: January 29, 2020
• First Submitted That Met QC Criteria: January 29, 2020
• First Posted (ACTUAL): January 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 9, 2020
• Last Update Submitted That Met QC Criteria: April 8, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Dermatologic Agents; Protein Kinase Inhibitors; BMS-986165
• Other Study ID Numbers: IM011-096

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No