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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04209699
Recruitment Status : Completed
First Posted : December 24, 2019
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

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Study Type : Interventional  (Clinical Trial)
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 : December 27, 2019
Actual Primary Completion Date : February 4, 2020
Actual Study Completion Date : February 11, 2020


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




Primary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) for BMS-986165 for tablet dosed with high-fat high-calorie meal versus fasted condition [ Time Frame: Day 1 to Day 13 ]
  2. Maximum observed plasma concentration (Cmax) for BMS-986165 for tablet administered fasted after pretreatment with famotidine vs administered alone [ Time Frame: Day 1 to Day 13 ]
  3. 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 [ Time Frame: Day 1 to Day 13 ]
  4. 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 [ Time Frame: Day 1 to Day 13 ]
  5. 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 [ Time Frame: Day 1 to Day 13 ]
  6. 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 [ Time Frame: Day 1 to Day 13 ]

Secondary Outcome Measures :
  1. Incidence of Adverse Events (AEs) [ Time Frame: Up to 39 days ]
  2. Number of clinically significant changes in vital sign measurements [ Time Frame: Up to 18 days ]
  3. Number of clinically significant changes in clinical laboratory test results [ Time Frame: Up to 18 days ]
  4. Number of clinically significant changes in electrocardiogram (ECG) parameters [ Time Frame: Up to 18 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04209699


Locations
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United States, Utah
PRA Health Sciences - Salt Lake
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04209699    
Other Study ID Numbers: IM011-119
First Posted: December 24, 2019    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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BMS-986165
Famotidine
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Dermatologic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors