A Phase 1 Drug-drug Interaction Study in Healthy Volunteers

NCT02227173 | Completed Phase 1

• 1 other identifier: IM136-004
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug-drug Interaction Study

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic parameters (maximum observed plasma concentration, area under the concentration-time curve) for montelukast, flurbiprofen, and digoxin

  Pharmacokinetic endpoints for montelukast, flurbiprofen, and digoxin with and without BMS-986020

  Predose and up to 168 hours post dose

Secondary Outcomes (2)

• Additional pharmacokinetic parameters for montelukast, flurbiprofen, and digoxin.

  Predose and up to 168 hour post dose

• Safety

  From dosing (Day 1) to Day 21

Study Arms (1)

Single-Sequence, A B C

EXPERIMENTAL

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

Interventions

BMS-986020 DRUG

Single-Sequence, A B C

Montelukast DRUG

Single-Sequence, A B C

Flurbiprofen DRUG

Single-Sequence, A B C

Digoxin DRUG

Single-Sequence, A B C

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

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

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Interventions

montelukast; Flurbiprofen; Digoxin

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates

Study Officials

• Emanuel DeNoia, MD

  ICON Development Solutions

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2014
• First Posted: August 27, 2014
• Study Start: September 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: November 18, 2014

Record last verified: 2014-10

Locations

US (1)