Study to Assess the Effect of Acid-reducing Agent Famotidine on the Drug Levels of BMS-986256 in Healthy Participants

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04470778
• Other study ID #: IM026-028
• Status: Completed
• Phase: Phase 1
• Start date: July 20, 2020
• Est. completion date: March 28, 2021

Study information

• Verified date: December 2021
• 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 due to famotidine administration on the drug levels of prototype BMS-986256 tablet formulation in healthy participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 28, 2021
• Est. primary completion date: March 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

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	ICON (PRA Health Sciences) - Salt Lake	Salt Lake City	Utah

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)		Up to 39 days
Primary	Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration AUC(0-T)		Up to 39 days
Primary	Area under the plasma concentration-time curve from time zero extrapolated to infinite time AUC(INF)		Up to 39 days
Secondary	Incidence of Adverse Events (AEs)		Up to 47 days
Secondary	Incidence of Serious Adverse Events (SAEs)		Up to 74 days
Secondary	Incidence of clinically significant changes in clinical laboratory results: Hematology tests		Up to 67 days
Secondary	Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests		Up to 67 days
Secondary	Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests		Up to 67 days
Secondary	Incidence of clinically significant changes in vital signs: Body temperature		Up to 74 days
Secondary	Incidence of clinically significant changes in vital signs: Respiratory rate		Up to 74 days
Secondary	Incidence of clinically significant changes in vital signs: Blood pressure		Up to 74 days
Secondary	Incidence of clinically significant changes in vital signs: Heart rate		Up to 74 days
Secondary	Incidence of clinically significant changes in 12-Lead electrocardiogram (ECG) parameters		Up to 74 days

External Links

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