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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04305899
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 10
• Actual Duration (Months): 2.8
• Patients Per Site Per Month: 14.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Participants	Drug: BMS-986165 Tablet formulation 1; Drug: BMS-986165 Tablet formulation 2	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Aug 31, 2020
• Actual Primary Completion Date: Nov 25, 2020
• Actual Study Completion Date: Nov 25, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Maximum concentration (Cmax) in plasma for BMS-986165 [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 [Up to 26 days]

3. Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) in plasma for BMS-986165 [Up to 26 days]

Secondary Outcome Measures

1. Incidence of Adverse Events (AEs) [Up to 26 days]

2. Incidence of Serious Adverse Events (SAEs) [Up to 98 days]

3. Incidence of clinically significant changes in physical examination findings [Up to 68 days]

4. Incidence of clinically significant changes in vital signs: Weight [Up to 68 days]

5. Incidence of clinically significant changes in vital signs: Body temperature [Up to 68 days]

6. Incidence of clinically significant changes in vital signs: Respiratory rate [Up to 68 days]

7. Incidence of clinically significant changes in vital signs: Blood pressure [Up to 68 days]

8. Incidence of clinically significant changes in vital signs: Heart rate [Up to 68 days]

9. Incidence of clinically significant changes in electrocardiogram (ECG) parameters [Up to 68 days]

10. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [Up to 68 days]

11. Incidence of clinically significant changes in clinical laboratory results: Clinical chemistry tests [Up to 68 days]

12. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [Up to 68 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PRA Health Sciences - Lenexa	Lenexa	Kansas	United States	66219

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT04305899
• Other Study ID Numbers: IM011-113
• First Posted: Mar 12, 2020
• Last Update Posted: Nov 11, 2021
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: BMS-986165

Study Results

No Results Posted as of Nov 11, 2021