A Phase 1 Drug-drug Interaction Study in Healthy Volunteers

Phase 1

Completed

• Conditions: Drug-drug Interaction Study
• Interventions: Drug: BMS-986020; Drug: Montelukast; Drug: Flurbiprofen; Drug: Digoxin

• Registration Number: NCT02227173
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-26
• Study First Submitted QC: 2014-08-26
• Study First Posted: 2014-08-27
• Study Start: 2014-09
• Status Verified: 2014-10
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Last Update Submitted: 2014-11-17
• Last Update Posted: 2014-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single-Sequence, A B C	Flurbiprofen	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
Single-Sequence, A B C	Montelukast	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
Single-Sequence, A B C	Digoxin	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
Single-Sequence, A B C	BMS-986020	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

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters (maximum observed plasma concentration, area under the concentration-time curve) for montelukast, flurbiprofen, and digoxin	Predose and up to 168 hours post dose	Pharmacokinetic endpoints for montelukast, flurbiprofen, and digoxin with and without BMS-986020

Secondary Outcome Measures

Name	Time	Method
Safety	From dosing (Day 1) to Day 21	Collection of adverse events and other physical parameters to assess safety
Additional pharmacokinetic parameters for montelukast, flurbiprofen, and digoxin.	Predose and up to 168 hour post dose	Additional pharmacokinetic parameters for montelukast, flurbiprofen, digoxin, and with and without BMS-986020

Trial Locations

Locations (1)

Healthcare Discoveries, LLC d/b/a ICON Development Solutions; 🇺🇸 San Antonio, Texas, United States