Rheumatoid ArthritisPhase 1NCT03245515
A Study of BMS-986195 in Healthy Male Subjects
A Phase 1 study testing BMS-986195 in people with Rheumatoid Arthritis, run by Bristol-Myers Squibb at 1 site in Netherlands.
Trial summary
The purpose of this study is to investigate the effects BMS-986195 in healthy male subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- BMS-986195
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Aug 2017to 5 Oct 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male subjects, if not surgically sterilized, must agree to use adequate contraception
- Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive (BMI = weight [kg]/[height (m)]2), and total body weight >50 kg
- All prescribed medication, including live vaccinations, must have been stopped at least 30 days prior to admission to the clinical research center
- All over-the-counter (OTC ) medication, vitamin preparations and other food supplements, or herbal medications (eg, St. John's Wort) must have been stopped at least 14 days prior to admission to the clinical research center
- Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks), and grapefruit (juice) from 3 days prior to admission to the clinical research center
- Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, ECG and vital signs, as judged by the Principal Investigator
Who cannot join
- Previous participation in the current study
- Known previous exposure to BMS-986195
- Employee of PRA or the Sponsor
- History of relevant drug and/or food allergies, including allergy to immunologic or related compounds or allergy to seafood or marine products
- Using tobacco products within 60 days prior to drug administration
- Positive screen for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies or anti-human immunodeficiency virus (HIV) 1 and 2 antibodies
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics and Metabolism of [14C] BMS-986195 in Healthy Male Subjects
The purpose of this study is to investigate the effects BMS-986195 in healthy male subjects.
- Conditions
- Rheumatoid Arthritis
- Being tested
- BMS-986195
- 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
| Study group | Role | What they receive |
|---|---|---|
| BMS-986195 | Experimental | A single oral solution dose of BMS-986195 Receives: Drug: BMS-986195 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
Measured: Up to 16 days
Time to attain maximum observed plasma concentration (tmax)
Measured: Up to 16 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(t-0)]
Measured: Up to 16 days
Area under the plasma concentration-time curve from time 0 to infinity calculated as: AUC0-inf = AUC0-t + Ĉlast/kel [AUC(0-inf)]
Measured: Up to 16 days
Percentage of estimated part for the calculation of AUC0-inf (%AUCextra)
Measured: Up to 16 days
Terminal elimination rate constant (kel)
Measured: Up to 16 days
Terminal elimination half life, calculated as 0.693/kel (t1/2)
Measured: Up to 16 days
Apparent oral clearance, calculated as dose/AUC0-inf (CL/F)
Measured: Up to 16 days
Apparent volume of distribution at terminal phase (Vz/F)
Measured: Up to 16 days
Ratio of AUC0-inf of BMS-986195 relative to total radioactivity (TRA) (%)
Measured: Up to 16 days
Ratio of AUC0-inf of plasma TRA relative to blood TRA (%)
Measured: Up to 16 days
Cumulative amount of TRA excreted in urine (Aeurine)
Measured: Up to 16 days
Cumulative amount of TRA excreted in feces (Aefeces)
Measured: Up to 16 days
Cumulative amount of TRA excreted in bile (Aebile)
Measured: Up to 16 days
Total amount of TRA excreted, calculated as Aetotal = Aeurine + Aefeces
Measured: Up to 16 days
Fraction of the dose administered excreted in urine (feurine)
Measured: Up to 16 days
Fraction of the dose administered excreted in feces (fefeces)
Measured: Up to 16 days
Fraction of the dose administered excreted in bile (febile)
Measured: Up to 16 days
Fraction of the dose administered excreted in urine and feces (fetotal)
Measured: Up to 16 days
Secondary outcomes (8)
Number of adverse events (AE)
Measured: Up to 16 days
Number of serious adverse events (SAE)
Measured: Up to 16 days
Number of laboratory test result abnormalities
Measured: Up to 16 days
Heart rate measured by ECG
Measured: Up to 16 days
PR-interval measured by ECG
Measured: Up to 16 days
QRS-duration measured by ECG
Measured: Up to 16 days
QT-interval measured by ECG
Measured: Up to 16 days
QTc-interval (Fridericia's) measured by ECG
Measured: Up to 16 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study start15 Aug 2017
- Primary completion22 Sep 2017
- Study completion5 Oct 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT03245515
- Sponsor's protocol ID
- IM014-016
- Other IDs
- 2017-002706-12, 2017
- Status last verified
- Jan 2018
- First submitted
- 8 Aug 2017
- Last updated
- 5 Jan 2018
- 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 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Metabolism of [14C] BMS-986195 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03245515
- Acronym / sponsor ID
- IM014-016
- 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
- 15 Aug 2017 (actual)
- Primary completion
- 22 Sep 2017 (actual)
- Study completion
- 5 Oct 2017 (actual)
- First posted
- 10 Aug 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.
The purpose of this study is to investigate the effects BMS-986195 in healthy male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BMS-986195 | Experimental | Drug: BMS-986195A single oral solution dose of BMS-986195 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male subjects, if not surgically sterilized, must agree to use adequate contraception
- Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive (BMI = weight [kg]/[height (m)]2), and total body weight >50 kg
- All prescribed medication, including live vaccinations, must have been stopped at least 30 days prior to admission to the clinical research center
- All over-the-counter (OTC ) medication, vitamin preparations and other food supplements, or herbal medications (eg, St. John's Wort) must have been stopped at least 14 days prior to admission to the clinical research center
- Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks), and grapefruit (juice) from 3 days prior to admission to the clinical research center
Key exclusion criteria (7 listed)
- Previous participation in the current study
- Known previous exposure to BMS-986195
- Employee of PRA or the Sponsor
- History of relevant drug and/or food allergies, including allergy to immunologic or related compounds or allergy to seafood or marine products
- Using tobacco products within 60 days prior to drug administration
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 | BMS-986195 |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Up to 16 days
Time to attain maximum observed plasma concentration (tmax)
Time frame: Up to 16 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(t-0)]
Time frame: Up to 16 days
Area under the plasma concentration-time curve from time 0 to infinity calculated as: AUC0-inf = AUC0-t + Ĉlast/kel [AUC(0-inf)]
Time frame: Up to 16 days
Percentage of estimated part for the calculation of AUC0-inf (%AUCextra)
Time frame: Up to 16 days
Terminal elimination rate constant (kel)
Time frame: Up to 16 days
Terminal elimination half life, calculated as 0.693/kel (t1/2)
Time frame: Up to 16 days
Apparent oral clearance, calculated as dose/AUC0-inf (CL/F)
Time frame: Up to 16 days
Apparent volume of distribution at terminal phase (Vz/F)
Time frame: Up to 16 days
Ratio of AUC0-inf of BMS-986195 relative to total radioactivity (TRA) (%)
Time frame: Up to 16 days
Ratio of AUC0-inf of plasma TRA relative to blood TRA (%)
Time frame: Up to 16 days
Cumulative amount of TRA excreted in urine (Aeurine)
Time frame: Up to 16 days
Cumulative amount of TRA excreted in feces (Aefeces)
Time frame: Up to 16 days
Cumulative amount of TRA excreted in bile (Aebile)
Time frame: Up to 16 days
Total amount of TRA excreted, calculated as Aetotal = Aeurine + Aefeces
Time frame: Up to 16 days
Fraction of the dose administered excreted in urine (feurine)
Time frame: Up to 16 days
Fraction of the dose administered excreted in feces (fefeces)
Time frame: Up to 16 days
Fraction of the dose administered excreted in bile (febile)
Time frame: Up to 16 days
Fraction of the dose administered excreted in urine and feces (fetotal)
Time frame: Up to 16 days
8 secondary outcomes
Number of adverse events (AE)
Time frame: Up to 16 days
Number of serious adverse events (SAE)
Time frame: Up to 16 days
Number of laboratory test result abnormalities
Time frame: Up to 16 days
Heart rate measured by ECG
Time frame: Up to 16 days
PR-interval measured by ECG
Time frame: Up to 16 days
QRS-duration measured by ECG
Time frame: Up to 16 days
QT-interval measured by ECG
Time frame: Up to 16 days
QTc-interval (Fridericia's) measured by ECG
Time frame: Up to 16 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 5 Jan 2018.
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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 in people with Rheumatoid 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 6 inclusion and 7 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 5 Jan 2018. 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: Up to 16 days). The study lists 19 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 5 Jan 2018.