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出境医 / 临床实验 / A Study to Determine the Effect of Famotidine on the Drug Levels of BMS-986256 in Healthy Participants

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

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 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
Estimated Study Start Date : June 25, 2021
Estimated Primary Completion Date : September 8, 2021
Estimated Study Completion Date : September 9, 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 Name: Pepcid
Experimental: Sequence BA Drug: BMS-986256
Specified dose on specified days

Drug: Famotidine
Specified dose on specified days
Other Name: Pepcid
Outcome Measures
Primary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) of BMS-986256 [ Time Frame: 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 [ Time Frame: Up to 19 days ]
  3. Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986256 [ Time Frame: Up to 19 days ]

Secondary Outcome Measures :
  1. Incidence of Adverse Events (AEs) [ Time Frame: Up to 45 days ]
  2. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 45 days ]
  3. Incidence of clinically significant changes in clinical laboratory values: Hematology tests [ Time Frame: Up to 45 days ]
  4. Incidence of clinically significant changes in clinical laboratory values: Chemistry tests [ Time Frame: Up to 45 days ]
  5. Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests [ Time Frame: Up to 45 days ]
  6. Incidence of clinically significant changes in vital signs: Body temperature [ Time Frame: Up to 45 days ]
  7. Incidence of clinically significant changes in vital signs: Respiratory rate [ Time Frame: Up to 45 days ]
  8. Incidence of clinically significant changes in vital signs: Blood pressure [ Time Frame: Up to 45 days ]
  9. Incidence of clinically significant changes in vital signs: Heart rate [ Time Frame: Up to 45 days ]
  10. Incidence of clinically significant changes in Electrocardiogram (ECG) parameters: PR interval [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: Up to 45 days ]
  15. Ratio of AUC(0-T) of BMS-986256 (with famotidine versus without famotidine) [ Time Frame: Up to 45 days ]
  16. Ratio of AUC(INF) of BMS-986256 (with famotidine versus without famotidine) [ Time Frame: Up to 45 days ]
  17. Time of maximum observed plasma concentration (Tmax) of BMS-986256 [ Time Frame: Up to 45 days ]
  18. Apparent terminal plasma half-life (T-HALF) of BMS-986256 [ Time Frame: Up to 45 days ]
  19. Apparent total body clearance (CLT/F) of BMS-986256 [ Time Frame: Up to 45 days ]
  20. Apparent volume of distribution of terminal phase (Vz/F) of BMS-986256 [ Time Frame: Up to 45 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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

Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email must contain NCT # and Site #.

Locations
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United States, Texas
Local Institution
Austin, Texas, United States, 78744
Contact: Site 0001         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Tracking Information
First Submitted Date  ICMJE June 24, 2021
First Posted Date  ICMJE June 28, 2021
Last Update Posted Date June 28, 2021
Estimated Study Start Date  ICMJE June 25, 2021
Estimated Primary Completion Date September 8, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2021)
  • Maximum observed plasma concentration (Cmax) of BMS-986256 [ Time Frame: Up to 19 days ]
  • Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) of BMS-986256 [ Time Frame: Up to 19 days ]
  • Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986256 [ Time Frame: Up to 19 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2021)
  • Incidence of Adverse Events (AEs) [ Time Frame: Up to 45 days ]
  • Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 45 days ]
  • Incidence of clinically significant changes in clinical laboratory values: Hematology tests [ Time Frame: Up to 45 days ]
  • Incidence of clinically significant changes in clinical laboratory values: Chemistry tests [ Time Frame: Up to 45 days ]
  • Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests [ Time Frame: Up to 45 days ]
  • Incidence of clinically significant changes in vital signs: Body temperature [ Time Frame: Up to 45 days ]
  • Incidence of clinically significant changes in vital signs: Respiratory rate [ Time Frame: Up to 45 days ]
  • Incidence of clinically significant changes in vital signs: Blood pressure [ Time Frame: Up to 45 days ]
  • Incidence of clinically significant changes in vital signs: Heart rate [ Time Frame: Up to 45 days ]
  • Incidence of clinically significant changes in Electrocardiogram (ECG) parameters: PR interval [ Time Frame: Up to 45 days ]
    PR interval is the time from the onset of the P wave to the start of the QRS complex
  • Incidence of clinically significant changes in ECG parameters: QRS [ Time Frame: Up to 45 days ]
    QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization
  • Incidence of clinically significant changes in ECG parameters: QT interval [ Time Frame: Up to 45 days ]
    The QT interval is the time from the start of the Q wave to the end of the T wave
  • Incidence of clinically significant changes in ECG parameters: QTcF [ Time Frame: 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
  • Ratio of Cmax of BMS-986256 (with famotidine versus without famotidine) [ Time Frame: Up to 45 days ]
  • Ratio of AUC(0-T) of BMS-986256 (with famotidine versus without famotidine) [ Time Frame: Up to 45 days ]
  • Ratio of AUC(INF) of BMS-986256 (with famotidine versus without famotidine) [ Time Frame: Up to 45 days ]
  • Time of maximum observed plasma concentration (Tmax) of BMS-986256 [ Time Frame: Up to 45 days ]
  • Apparent terminal plasma half-life (T-HALF) of BMS-986256 [ Time Frame: Up to 45 days ]
  • Apparent total body clearance (CLT/F) of BMS-986256 [ Time Frame: Up to 45 days ]
  • Apparent volume of distribution of terminal phase (Vz/F) of BMS-986256 [ Time Frame: Up to 45 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Determine the Effect of Famotidine on the Drug Levels of BMS-986256 in Healthy Participants
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Participants
Intervention  ICMJE
  • Drug: BMS-986256
    Specified dose on specified days
  • Drug: Famotidine
    Specified dose on specified days
    Other Name: Pepcid
Study Arms  ICMJE
  • Experimental: Sequence AB
    Interventions:
    • Drug: BMS-986256
    • Drug: Famotidine
  • Experimental: Sequence BA
    Interventions:
    • Drug: BMS-986256
    • Drug: Famotidine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 24, 2021) 		24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 9, 2021
Estimated Primary Completion Date September 8, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email must contain NCT # and Site #.
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04941755
Other Study ID Numbers  ICMJE IM026-029
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP