A Study Comparing the Effects of Famotidine Pretreatment and of Food on the Relative Bioavailability of BMS-986165 in Healthy Volunteers

Healthy Participants Clinical Trial

Official title:

An Open-label 3×3 Cross-over Study to Compare Effects of Famotidine Pretreatment and of Food on the Relative Bioavailability of Single Doses of BMS-986165 in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04209699
• Other study ID #: IM011-119
• Status: Completed
• Phase: Phase 1
• Start date: December 27, 2019
• Est. completion date: February 11, 2020

Study information

• Verified date: April 2020
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to evaluate the effects of food and pH on the relative bioavailability (BA) of the tablet formulation of BMS-986165 in healthy volunteers

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 11, 2020
• Est. primary completion date: February 4, 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:

• Body mass index of 18.0 kg/m^2 to 32.0 kg/m^2, inclusive, and body weight = 50 kg, at screening

• Male and female paritcipants, aged 18 years, or age of majority, to age 55 years, inclusive

• All female subjects must have a negative serum or urine pregnancy test

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.

• History of administration of live vaccines within 60 days before screening until clinic discharge

• Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population

Other protocol-defined inclusion/exclusion criteria could apply

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• BMS-986165
Single dose
• Famotidine
Single dose

Locations

Country	Name	City	State
United States	PRA Health Sciences - Salt Lake	Salt Lake City	Utah

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 observed plasma concentration (Cmax) for BMS-986165 for tablet dosed with high-fat high-calorie meal versus fasted condition		Day 1 to Day 13
Primary	Maximum observed plasma concentration (Cmax) for BMS-986165 for tablet administered fasted after pretreatment with famotidine vs administered alone		Day 1 to Day 13
Primary	Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) in plasma for BMS-986165 for a tablet dosed with high-fat high-calorie meal versus fasted condition		Day 1 to Day 13
Primary	Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) in plasma for BMS-986165 for tablet administered fasted after pretreatment with famotidine vs administered alone		Day 1 to Day 13
Primary	Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) in plasma for BMS-986165 for tablet dosed with high-fat high-calorie meal versus fasted condition		Day 1 to Day 13
Primary	Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) in plasma for BMS-986165 for tablet administered fasted after pretreatment with famotidine vs administered alone		Day 1 to Day 13
Secondary	Incidence of Adverse Events (AEs)		Up to 39 days
Secondary	Number of clinically significant changes in vital sign measurements		Up to 18 days
Secondary	Number of clinically significant changes in clinical laboratory test results		Up to 18 days
Secondary	Number of clinically significant changes in electrocardiogram (ECG) parameters		Up to 18 days

External Links

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