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A Study to Evaluate the Effect of Omeprazole on the Pharmacokinetics of BMS-986205 in Healthy Participants

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ClinicalTrials.gov Identifier: NCT03936374
Recruitment Status : Not yet recruiting
First Posted : May 3, 2019
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to assess the effect of multiple dose administrations of Omeprazole on the pharmacokinetics of BMS-986205.

Condition or disease Intervention/treatment Phase
Healthy Drug: BMS-986205 Drug: omeprazole Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Study to Evaluate the Effect of Coadministration of a Proton Pump Inhibitor (Omeprazole) on the Pharmacokinetics of BMS-986205 in Healthy Subjects
Estimated Study Start Date : May 2, 2019
Estimated Primary Completion Date : July 3, 2019
Estimated Study Completion Date : July 3, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BMS-986205 + Omeprazole Drug: BMS-986205
Participants will receive BMS-986205 on Days 1 and 15

Drug: omeprazole
Participants will receive omeprazole on Days 10 to 15




Primary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) of BMS-986205 [ Time Frame: Up to Day 29 ]
  2. Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)] of BMS-986205 [ Time Frame: Up to Day 29 ]
  3. Area Under the Plasma Concentration-time Curve from Time Zero Extrapolated to Infinite Time [AUC(INF)] [ Time Frame: Up to Day 29 ]

Secondary Outcome Measures :
  1. Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation [ Time Frame: Up to Day 36 ]
  2. Number of Participants with Vital Sign Abnormalities [ Time Frame: Up to Day 29 ]
  3. Number of Participants with 12-lead Electrocardiogram (ECG) Abnormalities [ Time Frame: Up to Day 29 ]
  4. Number of Participants with Physical Examination Abnormalities [ Time Frame: Up to Day 29 ]
  5. Number of Participants with Clinical Laboratory Results Abnormalities [ Time Frame: Up to Day 29 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Health male and female participants (not of childbearing potential) as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
  • normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) greater than or equal to (>=) 80 milliliter per minute per 1.73 meter square (mL/min/1.73 m^2)
  • Body mass index (BMI) of 18.0 kilogram per meter square (kg/m^2) to 32.0 kg/m^2
  • Women participants must have documented proof that they are not of childbearing potential

Exclusion Criteria:

  • Women who are of childbearing potential or breastfeeding
  • Active tuberculosis (TB) requiring treatment or documented latent TB within the previous 3 years
  • Concomitant use of strong inhibitors or strong inducers of CYP3A4
  • Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03936374


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 Not yet recruiting
Austin, Texas, United States, 78744
Contact: Site 0001         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Principal Investigator: Antonia Davidson, MD PPD

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03936374     History of Changes
Other Study ID Numbers: CA017-089
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action