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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04470778
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.2
• Patients Per Site Per Month: 4.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Participants	Drug: BMS-986256; Drug: Famotidine	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jul 20, 2020
• Actual Primary Completion Date: Mar 21, 2021
• Actual Study Completion Date: Mar 28, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BMS-986256	Drug: BMS-986256; Specified dose on specified days
Experimental: BMS-986256 + Famotidine	Drug: BMS-986256; Specified dose on specified days; Drug: Famotidine; Specified dose on specified days

Outcome Measures

Primary Outcome Measures

1. Maximum observed plasma concentration (Cmax) [Up to 39 days]

2. Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration AUC(0-T) [Up to 39 days]

3. Area under the plasma concentration-time curve from time zero extrapolated to infinite time AUC(INF) [Up to 39 days]

Secondary Outcome Measures

1. Incidence of Adverse Events (AEs) [Up to 47 days]

2. Incidence of Serious Adverse Events (SAEs) [Up to 74 days]

3. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [Up to 67 days]

4. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [Up to 67 days]

5. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [Up to 67 days]

6. Incidence of clinically significant changes in vital signs: Body temperature [Up to 74 days]

7. Incidence of clinically significant changes in vital signs: Respiratory rate [Up to 74 days]

8. Incidence of clinically significant changes in vital signs: Blood pressure [Up to 74 days]

9. Incidence of clinically significant changes in vital signs: Heart rate [Up to 74 days]

10. Incidence of clinically significant changes in 12-Lead electrocardiogram (ECG) parameters [Up to 74 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ICON (PRA Health Sciences) - Salt Lake	Salt Lake City	Utah	United States	84124

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT04470778
• Other Study ID Numbers: IM026-028
• First Posted: Jul 14, 2020
• Last Update Posted: Jan 11, 2022
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Famotidine

Study Results

No Results Posted as of Jan 11, 2022