Clinical trial NCT04941755: A Study to Determine the Effect of Famotidine on the Drug Levels of BMS-986256 in Healthy Participants
Official title: A Phase 1 Open-label, 2-Period 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
Keywords: Healthy Participants
BMS-986256
Famotidine
Gastric pH
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-06-28
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the effect of gastric pH changes induced by famotidine on the drug levels of BMS-986256.


Eligibility criteria: Inclusion Criteria:

* Healthy participants, defined as having no clinically significant deviations from normal in medical history
* Weight ≥ 50 kg and body mass index between 18.0 kg/m2 and 32.0 kg/m2, inclusive, at screening
* Normal renal function at screening

Exclusion Criteria:

* Any significant acute or chronic medical illness
* Current or recent gastrointestinal (GI) disease that could impact upon the absorption of study treatment
* Any major surgery within 4 weeks of study treatment administration
* Significant history of GI abnormalities

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) of BMS-986256
timeFrame: Up to 19 days
measure: Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) of BMS-986256
timeFrame: Up to 19 days
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986256
timeFrame: Up to 19 days
Secondary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 45 days
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: Up to 45 days
measure: Incidence of clinically significant changes in clinical laboratory values: Hematology tests
timeFrame: Up to 45 days
measure: Incidence of clinically significant changes in clinical laboratory values: Chemistry tests
timeFrame: Up to 45 days
measure: Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests
timeFrame: Up to 45 days
measure: Incidence of clinically significant changes in vital signs: Body temperature
timeFrame: Up to 45 days
measure: Incidence of clinically significant changes in vital signs: Respiratory rate
timeFrame: Up to 45 days
measure: Incidence of clinically significant changes in vital signs: Blood pressure
timeFrame: Up to 45 days
measure: Incidence of clinically significant changes in vital signs: Heart rate
timeFrame: Up to 45 days
measure: Incidence of clinically significant changes in Electrocardiogram (ECG) parameters: PR interval
timeFrame: Up to 45 days
measure: Incidence of clinically significant changes in ECG parameters: QRS
timeFrame: Up to 45 days
measure: Incidence of clinically significant changes in ECG parameters: QT interval
timeFrame: Up to 45 days
measure: Incidence of clinically significant changes in ECG parameters: QTcF
timeFrame: Up to 45 days
measure: Ratio of Cmax of BMS-986256 (with famotidine versus without famotidine)
timeFrame: Up to 45 days
measure: Ratio of AUC(0-T) of BMS-986256 (with famotidine versus without famotidine)
timeFrame: Up to 45 days
measure: Ratio of AUC(INF) of BMS-986256 (with famotidine versus without famotidine)
timeFrame: Up to 45 days
measure: Time of maximum observed plasma concentration (Tmax) of BMS-986256
timeFrame: Up to 45 days
measure: Apparent terminal plasma half-life (T-HALF) of BMS-986256
timeFrame: Up to 45 days
measure: Apparent total body clearance (CLT/F) of BMS-986256
timeFrame: Up to 45 days
measure: Apparent volume of distribution of terminal phase (Vz/F) of BMS-986256
timeFrame: Up to 45 days
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Development, LP
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: