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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT04209699

Collaborator

(none)

Enrollment

Location

Arms

1.5

Actual Duration (Months)

11.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Healthy Participants	Drug: BMS-986165 Drug: Famotidine	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Dec 27, 2019

Actual Primary Completion Date :

Feb 4, 2020

Actual Study Completion Date :

Feb 11, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment A: BMS-986165 alone, fasted	Drug: BMS-986165 Single dose
Experimental: Treatment B: BMS-986165 alone, fed	Drug: BMS-986165 Single dose
Experimental: Treatment C: BMS-986165 with famotidine pretreatment, fasted	Drug: BMS-986165 Single dose Drug: Famotidine Single dose

Arm

Intervention/Treatment

Experimental: Treatment A: BMS-986165 alone, fasted

Drug: BMS-986165

Single dose

Experimental: Treatment B: BMS-986165 alone, fed

Drug: BMS-986165

Single dose

Experimental: Treatment C: BMS-986165 with famotidine pretreatment, fasted

Drug: BMS-986165

Single dose

Drug: Famotidine

Single dose

Outcome Measures

Primary Outcome Measures

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]
Maximum observed plasma concentration (Cmax) for BMS-986165 for tablet administered fasted after pretreatment with famotidine vs administered alone [Day 1 to Day 13]
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]
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]
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]
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 Outcome Measures

Incidence of Adverse Events (AEs) [Up to 39 days]
Number of clinically significant changes in vital sign measurements [Up to 18 days]
Number of clinically significant changes in clinical laboratory test results [Up to 18 days]
Number of clinically significant changes in electrocardiogram (ECG) parameters [Up to 18 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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PRA Health Sciences - Salt Lake	Salt Lake City	Utah	United States	84124

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:

Publications

None provided.

Responsible Party:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT04209699

Other Study ID Numbers:

IM011-119

First Posted:

Dec 24, 2019

Last Update Posted:

Apr 21, 2020

Last Verified:

Apr 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

BMS-986165

Famotidine

Study Results

No Results Posted as of Apr 21, 2020