A Study to Determine the Effect of Famotidine on the Drug Levels of BMS-986256 in Healthy Participants

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04941755
• Other study ID #: IM026-029
• Status: Completed
• Phase: Phase 1
• Start date: June 25, 2021
• Est. completion date: September 24, 2021

Study information

• Verified date: January 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 24, 2021
• Est. primary completion date: September 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• BMS-986256
Specified dose on specified days
• Famotidine
Specified dose on specified days

Locations

Country	Name	City	State
United States	PPD Development, LP	Austin	Texas

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) of BMS-986256		Up to 19 days
Primary	Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) of BMS-986256		Up to 19 days
Primary	Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986256		Up to 19 days
Secondary	Incidence of Adverse Events (AEs)		Up to 45 days
Secondary	Incidence of Serious Adverse Events (SAEs)		Up to 45 days
Secondary	Incidence of clinically significant changes in clinical laboratory values: Hematology tests		Up to 45 days
Secondary	Incidence of clinically significant changes in clinical laboratory values: Chemistry tests		Up to 45 days
Secondary	Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests		Up to 45 days
Secondary	Incidence of clinically significant changes in vital signs: Body temperature		Up to 45 days
Secondary	Incidence of clinically significant changes in vital signs: Respiratory rate		Up to 45 days
Secondary	Incidence of clinically significant changes in vital signs: Blood pressure		Up to 45 days
Secondary	Incidence of clinically significant changes in vital signs: Heart rate		Up to 45 days
Secondary	Incidence of clinically significant changes in Electrocardiogram (ECG) parameters: PR interval	PR interval is the time from the onset of the P wave to the start of the QRS complex	Up to 45 days
Secondary	Incidence of clinically significant changes in ECG parameters: QRS	QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization	Up to 45 days
Secondary	Incidence of clinically significant changes in ECG parameters: QT interval	The QT interval is the time from the start of the Q wave to the end of the T wave	Up to 45 days
Secondary	Incidence of clinically significant changes in ECG parameters: QTcF	QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave	Up to 45 days
Secondary	Ratio of Cmax of BMS-986256 (with famotidine versus without famotidine)		Up to 45 days
Secondary	Ratio of AUC(0-T) of BMS-986256 (with famotidine versus without famotidine)		Up to 45 days
Secondary	Ratio of AUC(INF) of BMS-986256 (with famotidine versus without famotidine)		Up to 45 days
Secondary	Time of maximum observed plasma concentration (Tmax) of BMS-986256		Up to 45 days
Secondary	Apparent terminal plasma half-life (T-HALF) of BMS-986256		Up to 45 days
Secondary	Apparent total body clearance (CLT/F) of BMS-986256		Up to 45 days
Secondary	Apparent volume of distribution of terminal phase (Vz/F) of BMS-986256		Up to 45 days

External Links

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