LupusPhase 1NCT03402087
A Study to Investigate BMS-986165 and Methotrexate in Healthy Male Patients
A Phase 1 study testing Methotrexate, Leucovorin and BMS-986165 in people with Lupus and Psoriatic Arthritis, run by Bristol-Myers Squibb at 1 site in Netherlands.
Trial summary
The purpose of this study is to investigate effects of BMS-986165 on blood levels of methotrexate given as a single dose in healthy male patients. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Lupus, Psoriatic Arthritis
- What is being tested?
- Methotrexate, Leucovorin and BMS-986165
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 8 Jan 2018to 25 Mar 2018
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index (BMI): 18.0 - 32.0 kg/m2
- Normal renal function at screening
Who cannot join
- Any medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease
- Any contraindication indicated in the MTX package insert
- History or presence of chronic bacterial or viral infection
- History or presence of an autoimmune disorder
- Any significant acute or chronic medical illness
- Active TB requiring treatment or documented latent TB within the previous 3 years
- Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Single-Sequence Study to Investigate the Effects of BMS-986165 on the Single-Dose Pharmacokinetics of Methotrexate in Healthy Male Subjects
The purpose of this study is to investigate effects of BMS-986165 on blood levels of methotrexate given as a single dose in healthy male patients.
- Conditions
- Lupus, Psoriatic Arthritis
- Being tested
- Methotrexate, Leucovorin, BMS-986165
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Also called MTX
Specified dose on specified days
LeucovorinDrug
Also called LEU
Specified dose on specified days
BMS-986165Drug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| BMS-986165+Methotrexate+Leucovorin | Experimental | Three treatments administered Receives: Drug: Methotrexate; Drug: Leucovorin; Drug: BMS-986165 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
Measured: Approximately 14 days
Time to attain maximum observed plasma concentration (Tmax)
Measured: Approximately 14 days
Area under the plasma concentration-time curve up to time T, where T is the last point with concentrations above the lower limit of quantitation [AUC(0-T)]
Measured: Approximately 14 days
Area under the plasma concentration-time curve from time 0 to infinity [AUC(INF)]
Measured: Approximately 14 days
Terminal elimination rate constant (kel)
Measured: Approximately 14 days
Terminal elimination half life, calculated as 0.693/kel (T-HALF)
Measured: Approximately 14 days
Apparent oral clearance (CL/F)
Measured: Approximately 14 days
Secondary outcomes (2)
Incidence of adverse events (AEs)
Measured: Approximately 19 days
Incidence of serious adverse events (SAEs)
Measured: Approximately 19 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start8 Jan 2018
- Primary completion20 Mar 2018
- Study completion25 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LupusStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT03402087
- Sponsor's protocol ID
- IM011-025
- Other IDs
- 2017-004177-13, 2017
- Status last verified
- Feb 2020
- First submitted
- 5 Jan 2018
- Last updated
- 25 Feb 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Sequence Study to Investigate the Effects of BMS-986165 on the Single-Dose Pharmacokinetics of Methotrexate in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03402087
- Acronym / sponsor ID
- IM011-025
- Conditions
- Lupus, Psoriatic Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 20 Mar 2018 (actual)
- Study completion
- 25 Mar 2018 (actual)
- First posted
- 18 Jan 2018 (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.
The purpose of this study is to investigate effects of BMS-986165 on blood levels of methotrexate given as a single dose in healthy male patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BMS-986165+Methotrexate+Leucovorin | Experimental | Drug: Methotrexate, Drug: Leucovorin, Drug: BMS-986165Three treatments administered |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body Mass Index (BMI): 18.0 - 32.0 kg/m2
- Normal renal function at screening
Key exclusion criteria (8 listed)
- Any medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease
- Any contraindication indicated in the MTX package insert
- History or presence of chronic bacterial or viral infection
- History or presence of an autoimmune disorder
- Any significant acute or chronic medical illness
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 |
|---|---|---|
| MethotrexateAlso: MTXSpecified dose on specified days | Drug | BMS-986165+Methotrexate+Leucovorin |
| LeucovorinAlso: LEUSpecified dose on specified days | Drug | BMS-986165+Methotrexate+Leucovorin |
| BMS-986165Specified dose on specified days | Drug | BMS-986165+Methotrexate+Leucovorin |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Approximately 14 days
Time to attain maximum observed plasma concentration (Tmax)
Time frame: Approximately 14 days
Area under the plasma concentration-time curve up to time T, where T is the last point with concentrations above the lower limit of quantitation [AUC(0-T)]
Time frame: Approximately 14 days
Area under the plasma concentration-time curve from time 0 to infinity [AUC(INF)]
Time frame: Approximately 14 days
Terminal elimination rate constant (kel)
Time frame: Approximately 14 days
Terminal elimination half life, calculated as 0.693/kel (T-HALF)
Time frame: Approximately 14 days
Apparent oral clearance (CL/F)
Time frame: Approximately 14 days
2 secondary outcomes
Incidence of adverse events (AEs)
Time frame: Approximately 19 days
Incidence of serious adverse events (SAEs)
Time frame: Approximately 19 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 25 Feb 2020.
Related trials for Lupus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingObservational study
Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires
Systemic Lupus Erythematosus (Sle), Primary Ovarian Insufficiency (Poi)
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
Active, not recruiting
Fatigue in Lupus Intervention Programmes (FLIP)
Systemic Lupus Erythematosus
RecruitingPhase 1
A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus
SLE, SLE (Systemic Lupus)
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 Methotrexate, Leucovorin and BMS-986165 in people with Lupus and Psoriatic Arthritis, run by Bristol-Myers Squibb at 1 site in Netherlands.
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 8 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 25 Feb 2020. 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 Netherlands. 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: Approximately 14 days). The study lists 7 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 25 Feb 2020.