Rheumatoid ArthritisPhase 1NCT03131973
Effects of Concomitant Administration of BMS-986195 on Methotrexate, Caffeine, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin
A Phase 1 study testing BMS-986195, Methotrexate and Leucovorin in people with Rheumatoid Arthritis, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
Drug-drug interaction study in healthy men and women not of childbearing potential. Assess the effect of BMS-986195 on the pharmacokinetics of methotrexate, caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- BMS-986195, Methotrexate and Leucovorin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2017to 10 Nov 2017
- 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 (not of childbearing potential) participants as determined by medical and surgical history and assessments
- Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive
- Normal kidney function at screening
Who cannot join
- History of chronic headaches (eg, migraines, cluster headaches), defined as occurring 15 days or more a month, over the previous 3 months
- History of headaches related to caffeine withdrawal, including energy drinks
- History of syncope, orthostatic instability, or recurrent dizziness
- Other protocol defined inclusion and exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Concomitant Administration of BMS-986195 on the Single-dose Pharmacokinetics of Methotrexate and Probe Substrates for Cytochrome P450 1A2, 2C8, 2C9, 2C19, 3A4, Organic Anion Transporter Polypeptide 1B1 and P-glycoprotein in Healthy Participants
Drug-drug interaction study in healthy men and women not of childbearing potential. Assess the effect of BMS-986195 on the pharmacokinetics of methotrexate, caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin. Collect data on safety of BMS-986195 and methotrexate, caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin. Collect data on multiple-dose pharmacodynamics of BMS-986195.
- Conditions
- Rheumatoid Arthritis
- Being tested
- BMS-986195, Methotrexate, Leucovorin, Caffeine, Montelukast
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986195Drug
Specified dose on specified days
MethotrexateDrug
Specified dose on specified days
LeucovorinDrug
Specified dose on specified days
CaffeineDrug
Specified dose on specified days
MontelukastDrug
Specified dose on specified days
FlurbiprofenDrug
Specified dose on specified days
OmeprazoleDrug
Specified dose on specified days
MidazolamDrug
Specified dose on specified days
DigoxinDrug
Specified dose on specified days
PravastatinDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Methotrexate | Experimental | Methotrexate single oral dose followed by leucovorin single oral dose on specified days followed by BMS-986195 coadministered with methotrexate single oral dose followed by leucovorin single oral dose on specified days Receives: Drug: BMS-986195; Drug: Methotrexate; Drug: Leucovorin |
| Cytochrome P450 and Transporter Substrates | Experimental | Caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin single oral dose on specified days, BMS-986195 multiple oral dose administration on specified days, and BMS-986195 coadministered with caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin single oral dose on specified days. Receives: Drug: BMS-986195; Drug: Caffeine; Drug: Montelukast; Drug: Flurbiprofen; Drug: Omeprazole; Drug: Midazolam; Drug: Digoxin; Drug: Pravastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
Measured by plasma concentrations
Measured: Up to 26 days
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
Measured by plasma concentrations
Measured: Up to 26 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Measured by plasma concentrations
Measured: Up to 26 days
Secondary outcomes (8)
Number of participants with adverse events
Measured by investigator assessment
Measured: Up to 28 days
Number of participants with serious adverse events
Measured by investigator assessment
Measured: Up to 45 days
Number of participants with adverse events leading to discontinuation
Measured by investigator assessment
Measured: Up to 28 days
Number of participants with clinical laboratory test abnormalities
Measured: Up to 28 days
Number of participants with vital sign measurement abnormalities
Measured: Up to 28 days
Number of participants with electrocardiogram abnormalities
Measured: Up to 28 days
Number of participants with physical examination abnormalities
Measured: Up to 28 days
Number of participants with marked abnormalities in clinical laboratory test results
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start13 May 2017
- Primary completion5 Nov 2017
- Study completion10 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03131973
- Sponsor's protocol ID
- IM014-013
- Status last verified
- Dec 2017
- First submitted
- 25 Apr 2017
- Last updated
- 15 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Concomitant Administration of BMS-986195 on the Single-dose Pharmacokinetics of Methotrexate and Probe Substrates for Cytochrome P450 1A2, 2C8, 2C9, 2C19, 3A4, Organic Anion Transporter Polypeptide 1B1 and P-glycoprotein in Healthy Participants
- ClinicalTrials.gov ID
- NCT03131973
- Acronym / sponsor ID
- IM014-013
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 13 May 2017 (actual)
- Primary completion
- 5 Nov 2017 (actual)
- Study completion
- 10 Nov 2017 (actual)
- First posted
- 27 Apr 2017 (actual)
- 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.
Drug-drug interaction study in healthy men and women not of childbearing potential. Assess the effect of BMS-986195 on the pharmacokinetics of methotrexate, caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin. Collect data on safety of BMS-986195 and methotrexate, caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin. Collect data on multiple-dose pharmacodynamics of BMS-986195.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methotrexate | Experimental | Drug: BMS-986195, Drug: Methotrexate, Drug: LeucovorinMethotrexate single oral dose followed by leucovorin single oral dose on specified days followed by BMS-986195 coadministered with methotrexate single oral dose followed by leucovorin single oral dose on specified days |
| Cytochrome P450 and Transporter Substrates | Experimental | Drug: BMS-986195, Drug: Caffeine, Drug: Montelukast, Drug: Flurbiprofen, Drug: Omeprazole, Drug: Midazolam, Drug: Digoxin, Drug: PravastatinCaffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin single oral dose on specified days, BMS-986195 multiple oral dose administration on specified days, and BMS-986195 coadministered with caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin single oral dose on specified days. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male and female (not of childbearing potential) participants as determined by medical and surgical history and assessments
- Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive
- Normal kidney function at screening
Key exclusion criteria (4 listed)
- History of chronic headaches (eg, migraines, cluster headaches), defined as occurring 15 days or more a month, over the previous 3 months
- History of headaches related to caffeine withdrawal, including energy drinks
- History of syncope, orthostatic instability, or recurrent dizziness
- Other protocol defined inclusion and 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-986195Specified dose on specified days | Drug | Cytochrome P450 and Transporter Substrates, Methotrexate |
| MethotrexateSpecified dose on specified days | Drug | Methotrexate |
| LeucovorinSpecified dose on specified days | Drug | Methotrexate |
| CaffeineSpecified dose on specified days | Drug | Cytochrome P450 and Transporter Substrates |
| MontelukastSpecified dose on specified days | Drug | Cytochrome P450 and Transporter Substrates |
| FlurbiprofenSpecified dose on specified days | Drug | Cytochrome P450 and Transporter Substrates |
| OmeprazoleSpecified dose on specified days | Drug | Cytochrome P450 and Transporter Substrates |
| MidazolamSpecified dose on specified days | Drug | Cytochrome P450 and Transporter Substrates |
| DigoxinSpecified dose on specified days | Drug | Cytochrome P450 and Transporter Substrates |
| PravastatinSpecified dose on specified days | Drug | Cytochrome P450 and Transporter Substrates |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Up to 26 days
Measured by plasma concentrations
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
Time frame: Up to 26 days
Measured by plasma concentrations
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time frame: Up to 26 days
Measured by plasma concentrations
8 secondary outcomes
Number of participants with adverse events
Time frame: Up to 28 days
Number of participants with serious adverse events
Time frame: Up to 45 days
Number of participants with adverse events leading to discontinuation
Time frame: Up to 28 days
Number of participants with clinical laboratory test abnormalities
Time frame: Up to 28 days
Number of participants with vital sign measurement abnormalities
Time frame: Up to 28 days
Number of participants with electrocardiogram abnormalities
Time frame: Up to 28 days
Number of participants with physical examination abnormalities
Time frame: Up to 28 days
Number of participants with marked abnormalities in clinical laboratory test results
Time frame: Up to 28 days
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 15 Dec 2017.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
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-986195, Methotrexate and Leucovorin in people with Rheumatoid Arthritis, 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 3 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 15 Dec 2017. 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?
Maximum observed plasma concentration (Cmax) (time frame: Up to 26 days). The study lists 3 primary outcomes in all. 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 15 Dec 2017.