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

November 17, 2014 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78209
        • Healthcare Discoveries, Llc D/B/A Icon Development Solutions

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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: Montelukast
Drug: Digoxin
Drug: BMS-986020
Drug: Flurbiprofen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Predose and up to 168 hours post dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Predose and up to 168 hour post dose
Safety
Time Frame: From dosing (Day 1) to Day 21
Collection of adverse events and other physical parameters to assess safety
From dosing (Day 1) to Day 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Principal Investigator: Emanuel DeNoia, MD, ICON Development Solutions

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

August 26, 2014

First Submitted That Met QC Criteria

August 26, 2014

First Posted (Estimate)

August 27, 2014

Study Record Updates

Last Update Posted (Estimate)

November 18, 2014

Last Update Submitted That Met QC Criteria

November 17, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM136-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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