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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04305899

Enrollment

Registered

2020-03-12

Start date

2020-08-31

Completion date

2020-11-25

Last updated

2021-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

Brief summary

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.

Interventions

DRUGBMS-986165 Tablet formulation 1

Specified dose on specified days

DRUGBMS-986165 Tablet formulation 2

Specified dose on specified days

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

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/

Design outcomes

Primary

Measure	Time frame
Maximum concentration (Cmax) in plasma for BMS-986165	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	Up to 26 days
Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) in plasma for BMS-986165	Up to 26 days

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026