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A Phase 1 Drug-drug Interaction Study in Healthy Volunteers (DDI)

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ClinicalTrials.gov Identifier: NCT02227173
Recruitment Status : Completed
First Posted : August 27, 2014
Last Update Posted : November 18, 2014
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
This is an open-label, single-sequence, drug-drug interaction study in healthy male and female subjects. There is no formal research hypothesis to be statistically tested. It is expected that coadministration of BMS-986020 with montelukast, flurbiprofen, and digoxin may increase the exposure of montelukast, flurbiprofen, and digoxin.

Condition or disease Intervention/treatment Phase
Drug-drug Interaction Study Drug: BMS-986020 Drug: Montelukast Drug: Flurbiprofen Drug: Digoxin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Effect of BMS-986020 on the Pharmacokinetics of Montelukast, Flurbiprofen, and Digoxin as Probe Substrates for CYP2C8, CYP2C9, and P-gp
Study Start Date : September 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: Single-Sequence, A B C

Treatment A:

Single oral dose of montelukast, flurbiprofen, and digoxin on Day 1

Treatment B:

BMS-986020 orally twice daily (BID) on Day 8 through Day 10

Treatment C:

BMS-986020 orally BID, single oral dose of montelukast, flurbiprofen, and digoxin on Day 11; BMS-986020 BID on Day 12 through Day 17

Drug: BMS-986020
Drug: Montelukast
Drug: Flurbiprofen
Drug: Digoxin



Primary Outcome Measures :
  1. Pharmacokinetic parameters (maximum observed plasma concentration, area under the concentration-time curve) for montelukast, flurbiprofen, and digoxin [ Time Frame: Predose and up to 168 hours post dose ]
    Pharmacokinetic endpoints for montelukast, flurbiprofen, and digoxin with and without BMS-986020


Secondary Outcome Measures :
  1. Additional pharmacokinetic parameters for montelukast, flurbiprofen, and digoxin. [ Time Frame: Predose and up to 168 hour post dose ]
    Additional pharmacokinetic parameters for montelukast, flurbiprofen, digoxin, and with and without BMS-986020

  2. Safety [ Time Frame: From dosing (Day 1) to Day 21 ]
    Collection of adverse events and other physical parameters to assess safety



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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:

  • Healthy male and female nonsmoking subjects ages 18 to 50 years, inclusive, with a body mass index of 18.0 to 32.0 kg/m2, inclusive
  • Women of childbearing potential must agree to follow instructions for methods of contraception for the duration of the study

Exclusion Criteria:

  • Any significant acute or chronic medical illness
  • History of arrhythmias or palpitations associated with dizziness or fainting
  • History of clinically relevant cardiac disease

Other protocol defined exclusion criteria could apply


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): NCT02227173


Locations
United States, Texas
Healthcare Discoveries, LLC d/b/a ICON Development Solutions
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Principal Investigator: Emanuel DeNoia, MD ICON Development Solutions

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02227173     History of Changes
Other Study ID Numbers: IM136-004
First Posted: August 27, 2014    Key Record Dates
Last Update Posted: November 18, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Montelukast
Digoxin
Flurbiprofen
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Protective Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors