A Phase 1 Drug-drug Interaction Study in Healthy Volunteers

Study Overview
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Brief Summary
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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.

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

Conditions
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Drug-drug Interaction Study

Intervention / Treatment
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* Drug: BMS-986020
* Drug: Montelukast
* Drug: Flurbiprofen
* Drug: Digoxin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single-Sequence, A B C<br>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<br> <br> Drug: Montelukast<br> <br> Drug: Flurbiprofen<br> <br> Drug: Digoxin<br> <br> |

What is the study measuring?
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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 | 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. | Additional pharmacokinetic parameters for montelukast, flurbiprofen, digoxin, and with and without BMS-986020 | Predose and up to 168 hour post dose | 
| Safety | Collection of adverse events and other physical parameters to assess safety | From dosing (Day 1) to Day 21 |