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

Healthy Participants Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04305899
• Other study ID #: IM011-113
• Status: Completed
• Phase: Phase 1
• Start date: August 31, 2020
• Est. completion date: November 25, 2020

Study information

• Verified date: November 2021
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 25, 2020
• Est. primary completion date: November 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• BMS-986165 Tablet formulation 1
Specified dose on specified days
• BMS-986165 Tablet formulation 2
Specified dose on specified days

Locations

Country	Name	City	State
United States	PRA Health Sciences - Lenexa	Lenexa	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum concentration (Cmax) in plasma for BMS-986165		Up to 26 days
Primary	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
Primary	Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) in plasma for BMS-986165		Up to 26 days
Secondary	Incidence of Adverse Events (AEs)		Up to 26 days
Secondary	Incidence of Serious Adverse Events (SAEs)		Up to 98 days
Secondary	Incidence of clinically significant changes in physical examination findings		Up to 68 days
Secondary	Incidence of clinically significant changes in vital signs: Weight		Up to 68 days
Secondary	Incidence of clinically significant changes in vital signs: Body temperature		Up to 68 days
Secondary	Incidence of clinically significant changes in vital signs: Respiratory rate		Up to 68 days
Secondary	Incidence of clinically significant changes in vital signs: Blood pressure		Up to 68 days
Secondary	Incidence of clinically significant changes in vital signs: Heart rate		Up to 68 days
Secondary	Incidence of clinically significant changes in electrocardiogram (ECG) parameters		Up to 68 days
Secondary	Incidence of clinically significant changes in clinical laboratory results: Hematology tests		Up to 68 days
Secondary	Incidence of clinically significant changes in clinical laboratory results: Clinical chemistry tests		Up to 68 days
Secondary	Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests		Up to 68 days

External Links

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