Skip to main content
OpenTrials
Completed

NCT Number: NCT04305899

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Participants

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA Health Sciences - Lenexa

Lenexa, Kansas, 66219, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-986165 Tablet formulation 1

Drug

Specified dose on specified days

BMS-986165 Tablet formulation 2

Drug

Specified dose on specified days

Primary outcomes

  1. Maximum concentration (Cmax) in plasma for BMS-986165

    Time frame: Up to 26 days

  2. 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

  3. Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) in plasma for BMS-986165

    Time frame: Up to 26 days

Secondary outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: Up to 26 days

  2. Incidence of Serious Adverse Events (SAEs)

    Time frame: Up to 98 days

  3. Incidence of clinically significant changes in physical examination findings

    Time frame: Up to 68 days

  4. Incidence of clinically significant changes in vital signs: Weight

    Time frame: Up to 68 days

  5. Incidence of clinically significant changes in vital signs: Body temperature

    Time frame: Up to 68 days

  6. Incidence of clinically significant changes in vital signs: Respiratory rate

    Time frame: Up to 68 days

  7. Incidence of clinically significant changes in vital signs: Blood pressure

    Time frame: Up to 68 days

  8. Incidence of clinically significant changes in vital signs: Heart rate

    Time frame: Up to 68 days

  9. Incidence of clinically significant changes in electrocardiogram (ECG) parameters

    Time frame: Up to 68 days

  10. Incidence of clinically significant changes in clinical laboratory results: Hematology tests

    Time frame: Up to 68 days

  11. Incidence of clinically significant changes in clinical laboratory results: Clinical chemistry tests

    Time frame: Up to 68 days

  12. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests

    Time frame: Up to 68 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 12, 2020
Registry last updated
Nov 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.