A Phase 1 Drug-drug Interaction Study in Healthy Volunteers

Drug-drug Interaction Study Clinical Trial

— DDI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02227173
• Other study ID #: IM136-004
• Status: Completed
• Phase: Phase 1
• First received: August 26, 2014
• Last updated: November 17, 2014
• Start date: September 2014
• Est. completion date: November 2014

Study information

• Verified date: October 2014
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Drug-drug Interaction Study

Intervention

Drug:
• BMS-986020

• Montelukast

• Flurbiprofen

• Digoxin

Locations

Country	Name	City	State
United States	Healthcare Discoveries, LLC d/b/a ICON Development Solutions	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Additional pharmacokinetic parameters for montelukast, flurbiprofen, and digoxin.	Additional pharmacokinetic parameters for montelukast, flurbiprofen, digoxin, and with and without BMS-986020	Predose and up to 168 hour post dose	No
Secondary	Safety	Collection of adverse events and other physical parameters to assess safety	From dosing (Day 1) to Day 21	Yes