A Study to Compare the Taste and Levels in Blood Plasma of BMS-986165 When Taken as Different Formulations by Healthy Adult Participants

November 9, 2021 updated by: Bristol-Myers Squibb

An Open-Label Cross-Over Study to Compare Bioavailability, Dose Proportionality, and Palatability of Single Doses of BMS-986165 Minitablet Pediatric Formulation in Fasted and Fed Conditions Relative to Single Doses of BMS-986165 Clinical Formulations In Healthy Adult Participants

The purpose of this study is to compare the taste, and the levels in blood plasma of different tablet formulations of BMS-986165 when taken by healthy adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • PRA Health Sciences - Lenexa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 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:

  • Healthy participants, 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
  • Women and men must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

  • Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of/or active liver disease
  • Inability to tolerate oral medication
  • History of allergy to BMS-986165 or related compounds

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group 1
Drug: BMS-986165 Tablet formulation 1
Specified dose on specified days
Drug: BMS-986165 Tablet formulation 2
Specified dose on specified days
Experimental: Treatment Group 2
Drug: BMS-986165 Tablet formulation 1
Specified dose on specified days
Drug: BMS-986165 Tablet formulation 2
Specified dose on specified days
Experimental: Treatment Group 3
Drug: BMS-986165 Tablet formulation 1
Specified dose on specified days
Drug: BMS-986165 Tablet formulation 2
Specified dose on specified days
Experimental: Treatment Group 4
Drug: BMS-986165 Tablet formulation 1
Specified dose on specified days
Drug: BMS-986165 Tablet formulation 2
Specified dose on specified days
Experimental: Treatment Group 5
Drug: BMS-986165 Tablet formulation 1
Specified dose on specified days
Drug: BMS-986165 Tablet formulation 2
Specified dose on specified days
Experimental: Treatment Group 6
Drug: BMS-986165 Tablet formulation 1
Specified dose on specified days
Drug: BMS-986165 Tablet formulation 2
Specified dose on specified days
Experimental: Treatment Group 7
Drug: BMS-986165 Tablet formulation 1
Specified dose on specified days
Drug: BMS-986165 Tablet formulation 2
Specified dose on specified days
Experimental: Treatment Group 8
Drug: BMS-986165 Tablet formulation 1
Specified dose on specified days
Drug: BMS-986165 Tablet formulation 2
Specified dose on specified days
Experimental: Treatment Group 9
Drug: BMS-986165 Tablet formulation 1
Specified dose on specified days
Drug: BMS-986165 Tablet formulation 2
Specified dose on specified days
Experimental: Treatment Group 10
Drug: BMS-986165 Tablet formulation 1
Specified dose on specified days
Drug: BMS-986165 Tablet formulation 2
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum concentration (Cmax) in plasma for BMS-986165
Time Frame: Up to 26 days
Up to 26 days
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-T)) in plasma for BMS-986165
Time Frame: Up to 26 days
Up to 26 days
Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) in plasma for BMS-986165
Time Frame: Up to 26 days
Up to 26 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of Adverse Events (AEs)
Time Frame: Up to 26 days
Up to 26 days
Incidence of Serious Adverse Events (SAEs)
Time Frame: Up to 98 days
Up to 98 days
Incidence of clinically significant changes in physical examination findings
Time Frame: Up to 68 days
Up to 68 days
Incidence of clinically significant changes in vital signs: Weight
Time Frame: Up to 68 days
Up to 68 days
Incidence of clinically significant changes in vital signs: Body temperature
Time Frame: Up to 68 days
Up to 68 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Time Frame: Up to 68 days
Up to 68 days
Incidence of clinically significant changes in vital signs: Blood pressure
Time Frame: Up to 68 days
Up to 68 days
Incidence of clinically significant changes in vital signs: Heart rate
Time Frame: Up to 68 days
Up to 68 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters
Time Frame: Up to 68 days
Up to 68 days
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time Frame: Up to 68 days
Up to 68 days
Incidence of clinically significant changes in clinical laboratory results: Clinical chemistry tests
Time Frame: Up to 68 days
Up to 68 days
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Time Frame: Up to 68 days
Up to 68 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2020

Primary Completion (Actual)

November 25, 2020

Study Completion (Actual)

November 25, 2020

Study Registration Dates

First Submitted

March 10, 2020

First Submitted That Met QC Criteria

March 10, 2020

First Posted (Actual)

March 12, 2020

Study Record Updates

Last Update Posted (Actual)

November 11, 2021

Last Update Submitted That Met QC Criteria

November 9, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM011-113

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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