Drug-drug Interaction StudyPhase 1DDINCT02227173
A Phase 1 Drug-drug Interaction Study in Healthy Volunteers
A Phase 1 study testing BMS-986020, Montelukast and Flurbiprofen in people with Drug-drug Interaction Study, run by Bristol-Myers Squibb at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug-drug Interaction Study
- What is being tested?
- BMS-986020, Montelukast and Flurbiprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Nov 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Healthcare Discoveries, LLC d/b/a ICON Development Solutions
San Antonio, Texas, 78209
About this study
Official title: 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.
- Conditions
- Drug-drug Interaction Study
- Being tested
- BMS-986020, Montelukast, Flurbiprofen, Digoxin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986020Drug
MontelukastDrug
FlurbiprofenDrug
DigoxinDrug
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: BMS-986020; Drug: Montelukast; Drug: Flurbiprofen; Drug: Digoxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Predose and up to 168 hours post dose
Secondary outcomes (2)
Additional pharmacokinetic parameters for montelukast, flurbiprofen, and digoxin.
Additional pharmacokinetic parameters for montelukast, flurbiprofen, digoxin, and with and without BMS-986020
Measured: Predose and up to 168 hour post dose
Safety
Collection of adverse events and other physical parameters to assess safety
Measured: From dosing (Day 1) to Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-drug Interaction StudyStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emanuel DeNoia, MD, Principal investigator, ICON Development Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02227173
- Sponsor's protocol ID
- IM136-004
- Acronym
- DDI
- Status last verified
- Oct 2014
- First submitted
- 26 Aug 2014
- Last updated
- 18 Nov 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of BMS-986020 on the Pharmacokinetics of Montelukast, Flurbiprofen, and Digoxin as Probe Substrates for CYP2C8, CYP2C9, and P-gp
- ClinicalTrials.gov ID
- NCT02227173
- Acronym / sponsor ID
- DDI / IM136-004
- Conditions
- Drug-drug Interaction Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 27 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-Sequence, A B C | Experimental | Drug: BMS-986020, Drug: Montelukast, Drug: Flurbiprofen, Drug: DigoxinTreatment 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
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
2 secondary outcomes
Additional pharmacokinetic parameters for montelukast, flurbiprofen, and digoxin.
Time frame: Predose and up to 168 hour post dose
Safety
Time frame: From dosing (Day 1) to Day 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emanuel DeNoia, MD principal investigator
ICON Development Solutions
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986020, Montelukast and Flurbiprofen in people with Drug-drug Interaction Study, run by Bristol-Myers Squibb at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2014.