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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04941755
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Arms: 2
• Actual Duration (Months): 3
• Patients Per Site Per Month: 7.4

Study Details

Study Description

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.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• 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
• Actual Study Start Date: Jun 25, 2021
• Actual Primary Completion Date: Sep 24, 2021
• Actual Study Completion Date: Sep 24, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sequence AB	Drug: BMS-986256; Specified dose on specified days; Drug: Famotidine; Specified dose on specified days; Other Names: Pepcid
Experimental: Sequence BA	Drug: BMS-986256; Specified dose on specified days; Drug: Famotidine; Specified dose on specified days; Other Names: Pepcid

Outcome Measures

Primary Outcome Measures

1. Maximum observed plasma concentration (Cmax) of BMS-986256 [Up to 19 days]

2. 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]

3. Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986256 [Up to 19 days]

Secondary Outcome Measures

1. Incidence of Adverse Events (AEs) [Up to 45 days]

2. Incidence of Serious Adverse Events (SAEs) [Up to 45 days]

3. Incidence of clinically significant changes in clinical laboratory values: Hematology tests [Up to 45 days]

4. Incidence of clinically significant changes in clinical laboratory values: Chemistry tests [Up to 45 days]

5. Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests [Up to 45 days]

6. Incidence of clinically significant changes in vital signs: Body temperature [Up to 45 days]

7. Incidence of clinically significant changes in vital signs: Respiratory rate [Up to 45 days]

8. Incidence of clinically significant changes in vital signs: Blood pressure [Up to 45 days]

9. Incidence of clinically significant changes in vital signs: Heart rate [Up to 45 days]

10. Incidence of clinically significant changes in Electrocardiogram (ECG) parameters: PR interval [Up to 45 days]

    PR interval is the time from the onset of the P wave to the start of the QRS complex

11. Incidence of clinically significant changes in ECG parameters: QRS [Up to 45 days]

    QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization

12. Incidence of clinically significant changes in ECG parameters: QT interval [Up to 45 days]

    The QT interval is the time from the start of the Q wave to the end of the T wave

13. Incidence of clinically significant changes in ECG parameters: QTcF [Up to 45 days]

    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

14. Ratio of Cmax of BMS-986256 (with famotidine versus without famotidine) [Up to 45 days]

15. Ratio of AUC(0-T) of BMS-986256 (with famotidine versus without famotidine) [Up to 45 days]

16. Ratio of AUC(INF) of BMS-986256 (with famotidine versus without famotidine) [Up to 45 days]

17. Time of maximum observed plasma concentration (Tmax) of BMS-986256 [Up to 45 days]

18. Apparent terminal plasma half-life (T-HALF) of BMS-986256 [Up to 45 days]

19. Apparent total body clearance (CLT/F) of BMS-986256 [Up to 45 days]

20. Apparent volume of distribution of terminal phase (Vz/F) of BMS-986256 [Up to 45 days]

Eligibility Criteria

Criteria

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PPD Development, LP	Austin	Texas	United States	78744

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: NCT04941755
• Other Study ID Numbers: IM026-029
• First Posted: Jun 28, 2021
• Last Update Posted: Jan 21, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bristol-Myers Squibb: Healthy Participants; BMS-986256; Famotidine; Gastric pH
• Additional relevant MeSH terms: Famotidine

Study Results

No Results Posted as of Jan 21, 2022