Clinical trial NCT04470778: Study to Assess the Effect of Acid-reducing Agent Famotidine on the Drug Levels of BMS-986256 in Healthy Participants
Official title: A Phase 1, Open-label, Crossover Study to Assess the Effect of Acid-reducing Agent Famotidine on the Pharmacokinetics of BMS-986256 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2020-07-14
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of gastric pH changes due to famotidine administration on the drug levels of prototype BMS-986256 tablet formulation in healthy participants.


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy participants having no clinically significant deviations from normal in medical history, physical examination (PE) findings, electrocardiograms (ECGs), vital signs, and clinical laboratory results that would compromise the ability to participate, complete, and/or interpret the results of the study
* Weight ≥ 50 kg and body mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2 inclusive at screening
* Women and men must agree to follow specific methods of contraception, if applicable, while participating in the trial

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Any significant acute or chronic medical illness
* Any major surgery within 4 weeks of study treatment administration
* Any other sound medical, psychiatric, and/or social reason as determined by the investigator

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to 39 days
measure: Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration AUC(0-T)
timeFrame: Up to 39 days
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time AUC(INF)
timeFrame: Up to 39 days
Secondary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 47 days
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: Up to 74 days
measure: Incidence of clinically significant changes in clinical laboratory results: Hematology tests
timeFrame: Up to 67 days
measure: Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
timeFrame: Up to 67 days
measure: Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
timeFrame: Up to 67 days
measure: Incidence of clinically significant changes in vital signs: Body temperature
timeFrame: Up to 74 days
measure: Incidence of clinically significant changes in vital signs: Respiratory rate
timeFrame: Up to 74 days
measure: Incidence of clinically significant changes in vital signs: Blood pressure
timeFrame: Up to 74 days
measure: Incidence of clinically significant changes in vital signs: Heart rate
timeFrame: Up to 74 days
measure: Incidence of clinically significant changes in 12-Lead electrocardiogram (ECG) parameters
timeFrame: Up to 74 days
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: ICON (LPRA) - Salt Lake
state: Utah
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: