Rheumatoid ArthritisPhase 1NCT02456844

Study to Investigate the Effect of BMS-986142 on the Pharmacokinetics (PK) of Methotrexate and Probe Substrate Cocktail in Healthy Patients

A Phase 1 study testing Montelukast, Flurbiprofen, Midazolam, Digoxin, Pravastatin and BMS-986142 and Methotrexate, Leucovorin and BMS-986142 in people with Rheumatoid Arthritis, run by Bristol-Myers Squibb.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To study the Pharmacokinetics (PK) parameters of montelukast, flurbiprofen, midazolam, digoxin, pravastatin, and MTX when coadministered with BMS-986142. 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?: Montelukast, Flurbiprofen, Midazolam, Digoxin, Pravastatin and BMS-986142 and Methotrexate, Leucovorin and BMS-986142
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: No sites listed yet
Study dates: May 2015to Jul 2015
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

Groups 1 and 2:
Written informed consent from all subjects.
Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive
Non-smokers.
Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) of > 90 mL/min/1.73 m2 .
Subject reenrollment.

Show all 13Show fewer

Males who are sexually active with women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug plus 5 half-lives of BMS-986142.
Male subjects must be willing to refrain from sperm donation during the entire study plus 5 half-lives of BMS-986142.
Group 1 only:
Healthy male and female (not of childbearing potential) subjects as determined by medical history, and clinical assessments.
Women must have documented proof that they are not of childbearing potential and must not be breast feeding.
Group 2 only:
1. Healthy male subjects as determined by medical history, and clinical assessments.

Who cannot join

Administration of live vaccine including polio vaccine during the course of the study, 12 weeks prior to the first dose of study drug, or 30 days after the last dose of study drug.
Active tuberculosis (TB) requiring treatment within the previous 3 years.
History of herpes zoster.
Subjects who have experienced recent infection, upper respiratory infection,.

About this study

Official title: Effects of BMS-986142 on the Single-dose Pharmacokinetics of Methotrexate and Probe Substrates Montelukast (CYP2C8), Flurbiprofen (CYP2C9), Midazolam (CYP3A4), Digoxin (P-gp), and Pravastatin (OATP1B1) in Healthy Subjects

To study the Pharmacokinetics (PK) parameters of montelukast, flurbiprofen, midazolam, digoxin, pravastatin, and MTX when coadministered with BMS-986142.

Conditions: Rheumatoid Arthritis
Being tested: Montelukast, Flurbiprofen, Midazolam, Digoxin, Pravastatin and BMS-986142, Methotrexate, Leucovorin and BMS-986142
Medical subject headings: Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Montelukast, Flurbiprofen, Midazolam, Digoxin, Pravastatin and BMS-986142Drug
1. Montelukast 10-mg tablet: On Days 1 and 8,Single oral dose
2. Flurbiprofen 50-mg tablet: On Days 1 and 8,Single oral dose
3. Midazolam syrup 2.5 mL × 2 mg/mL (5 mg): On Days 1 and 8,Single oral dose
4. Digoxin (Lanoxin®) 0.25 mg tablet: On Days 1 and 8,Single oral dose
5. Pravastatin 40-mg tablet: On Days 1 and 8,Single oral dose
6. BMS-986142: On Days 6 through 12.
Methotrexate, Leucovorin and BMS-986142Drug
1. Methotrexate (MTX) single oral dose of 3 × 2.5-mg tablet (Days 1 and 8)
2. Leucovorin single oral dose of 15-mg tablet (Days 2 and 9; 24 hours after MTX administration)
3. BMS-986142 on Days 6 through 10.

Study groups in NCT02456844
Study group	Role	What they receive
Group 1	Experimental	Montelukast, Flurbiprofen, Midazolam, Digoxin, Pravastatin and BMS-986142 Receives: Drug: Montelukast, Flurbiprofen, Midazolam, Digoxin, Pravastatin and BMS-986142
Group 2	Experimental	Methotrexate,Leucovorin and BMS-986142 Receives: Drug: Methotrexate, Leucovorin and BMS-986142

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum observed plasma concentration (Cmax)
Measured: Days 1 through 10
Area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration, AUC(0-T)
Measured: Days 1 through 10
Area under the plasma concentration-time curve from time zero extrapolated to infinite time, AUC(INF)
Measured: Days 1 through 10

Secondary outcomes (7)

Time of maximum observed plasma concentration (Tmax)
Measured: Days 1 through 10
Terminal plasma half-life (T-half)
Measured: Days 1 through 10
Apparent total body clearance (parents only), CLT/F
Measured: Days 1 through 10
Ratio of metabolite Cmax to parent Cmax, corrected for molecular weight
Measured: Days 1 through 10
Ratio of metabolite AUC(0-T) to parent AUC(0-T), corrected for molecular weight
Measured: Days 1 through 10
Ratio of metabolite AUC(INF) to parent AUC(INF), corrected for molecular weight
Measured: Days 1 through 10
Trough observed plasma concentration (For BMS-986142 only)
Measured: Days 1 through 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2015Jul 2015

First posted29 May 2015 (estimated)
Study startMay 2015
Primary completionJul 2015
Study completionJul 2015

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: Basic science
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02456844
Sponsor's protocol ID: IM006-003
Status last verified: Jan 2016
First submitted: 27 May 2015
Last updated: 1 Feb 2016
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of BMS-986142 on the Single-dose Pharmacokinetics of Methotrexate and Probe Substrates Montelukast (CYP2C8), Flurbiprofen (CYP2C9), Midazolam (CYP3A4), Digoxin (P-gp), and Pravastatin (OATP1B1) in Healthy Subjects
ClinicalTrials.gov ID: NCT02456844
Acronym / sponsor ID: IM006-003
Conditions: Rheumatoid Arthritis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: May 2015
Primary completion: Jul 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 29 May 2015 (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.

To study the Pharmacokinetics (PK) parameters of montelukast, flurbiprofen, midazolam, digoxin, pravastatin, and MTX when coadministered with BMS-986142.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group 1	Experimental	Drug: Montelukast, Flurbiprofen, Midazolam, Digoxin, Pravastatin and BMS-986142Montelukast, Flurbiprofen, Midazolam, Digoxin, Pravastatin and BMS-986142
Group 2	Experimental	Drug: Methotrexate, Leucovorin and BMS-986142Methotrexate,Leucovorin and BMS-986142

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (13 listed)

Written informed consent from all subjects.
Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive
Non-smokers.
Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) of > 90 mL/min/1.73 m2 .
Subject reenrollment.

Key exclusion criteria (4 listed)

Administration of live vaccine including polio vaccine during the course of the study, 12 weeks prior to the first dose of study drug, or 30 days after the last dose of study drug.
Active tuberculosis (TB) requiring treatment within the previous 3 years.
History of herpes zoster.
Subjects who have experienced recent infection, upper respiratory infection,.

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
Montelukast, Flurbiprofen, Midazolam, Digoxin, Pravastatin and BMS-9861421. Montelukast 10-mg tablet: On Days 1 and 8,Single oral dose 2. Flurbiprofen 50-mg tablet: On Days 1 and 8,Single oral dose 3. Midazolam syrup 2.5 mL × 2 mg/mL (5 mg): On Days 1 and 8,Single oral dose 4. Digoxin (Lanoxin®) 0.25 mg tablet: On Days 1 and 8,Single oral dose 5. Pravastatin 40-mg tablet: On Days 1 and 8,Single oral dose 6. BMS-986142: On Days 6 through 12.	Drug	Group 1
Methotrexate, Leucovorin and BMS-9861421. Methotrexate (MTX) single oral dose of 3 × 2.5-mg tablet (Days 1 and 8) 2. Leucovorin single oral dose of 15-mg tablet (Days 2 and 9; 24 hours after MTX administration) 3. BMS-986142 on Days 6 through 10.	Drug	Group 2

Primary outcome

Maximum observed plasma concentration (Cmax)
Time frame: Days 1 through 10
Area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration, AUC(0-T)
Time frame: Days 1 through 10
Area under the plasma concentration-time curve from time zero extrapolated to infinite time, AUC(INF)
Time frame: Days 1 through 10

7 secondary outcomes

Time of maximum observed plasma concentration (Tmax)
Time frame: Days 1 through 10
Terminal plasma half-life (T-half)
Time frame: Days 1 through 10
Apparent total body clearance (parents only), CLT/F
Time frame: Days 1 through 10
Ratio of metabolite Cmax to parent Cmax, corrected for molecular weight
Time frame: Days 1 through 10
Ratio of metabolite AUC(0-T) to parent AUC(0-T), corrected for molecular weight
Time frame: Days 1 through 10
Ratio of metabolite AUC(INF) to parent AUC(INF), corrected for molecular weight
Time frame: Days 1 through 10
Trough observed plasma concentration (For BMS-986142 only)
Time frame: Days 1 through 10

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 1 Feb 2016.

Related trials for Rheumatoid Arthritis

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

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.

Thomas L Hunt, MD PhD principal investigator

PPD Development, LP

Questions about this trial

What is this clinical trial studying?

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 13 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 1 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

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: Days 1 through 10). 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?

On the ClinicalTrials.gov record for NCT02456844.

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 1 Feb 2016.