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OpenTrials
Completed

NCT Number: NCT02227173

A Phase 1 Drug-drug Interaction Study in Healthy Volunteers

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.

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Key information

Conditions

Drug-drug Interaction Study

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Healthcare Discoveries, LLC d/b/a ICON Development Solutions

San Antonio, Texas, 78209, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-986020

Drug

Montelukast

Drug

Flurbiprofen

Drug

Digoxin

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Effect of BMS-986020 on the Pharmacokinetics of Montelukast, Flurbiprofen, and Digoxin as Probe Substrates for CYP2C8, CYP2C9, and P-gp

Acronym: DDI

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 27, 2014
Registry last updated
Nov 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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