PsoriasisPhase 1NCT03004768
Pharmacokinetics and Metabolism of [14C]BMS-986165 in Healthy Male Participants
A Phase 1 study testing BMS-986165 in people with Psoriasis, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
An oral dose in healthy subjects to obtain information about the absorption, metabolism, and excretion (AME) of BMS-986165 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
- Psoriasis
- What is being tested?
- BMS-986165
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2017to 27 Feb 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed Informed Consent
- Target population: Healthy males with no clinically significant deviations from normal in medical history, physical examinations, vital signs, electrocardiograms (ECGs), physical measurements, and clinical laboratory tests
- Body weight of at least 50 kilograms (110 pounds); body mass index (BMI) between 18 to 32 kg/m2.
- No evidence of acute infection or other significant problem as determined from a review of a chest x-ray, medical history, and physical examination
Who cannot join
- History of any chronic or acute illness including active TB in the last 3 years, recent infection, gastrointestinal disease, smoking within less than 6 months prior to dosing, alcohol abuse, inability to tolerate oral medication, or inability to be venipunctured.
- Vaccination or plans for vaccination with any live vaccine 12 weeks prior to first dose of study drug, during the course of the study
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiograms, or clinical laboratory determinations beyond what is consistent with the target population.
- Participant with greater than Grade 2 acne.
- Participated in a radiolabeled drug study within the previous 12 months; clinically significant diagnostic or therapeutic radiation exposure within the previous 12 months; or current employment in a job requiring radiation exposure monitoring.
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Madison Clinical Research Unit
Madison, Wisconsin, 53704
About this study
An oral dose in healthy subjects to obtain information about the absorption, metabolism, and excretion (AME) of BMS-986165
- Conditions
- Psoriasis
- Being tested
- BMS-986165
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986165Drug
Oral solution dose of 24 mg [14C] BMS-986165 containing approximately 100 micro Ci of TRA
| Study group | Role | What they receive |
|---|---|---|
| Single dose of radiolabeled BMS-986165 | Experimental | Not described Receives: Drug: BMS-986165 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is PK exposure that will be determined from plasma concentration versus time
Measured: Day 1 to Day 13
Urinary/fecal TRA (Total radioactivity) recovery data
Measured: Day 1 to Day 13
PK terminal elimination half-life data (T-HALF)
Measured: Day 1 to Day 13
PK apparent total body clearance (CL/F)
Measured: Day 1 to Day 13
PK apparent volume of distribution (Vz/F)
Measured: Day 1 to Day 13
PK time of maximum observed plasma concentration (Tmax)
Measured: Day 1 to Day 13
Secondary outcomes (5)
Safety endpoints include the incidence of adverse events (AEs)
Measured: Day 1 to Day 13
Safety endpoints include the results of electrocardiogram tests (ECGs)
Measured: Day 1 to Day 13
Safety endpoints include the results of vital signs
Measured: Day 1 to Day 13
Safety endpoints include the results of physical exams
Measured: Day 1 to Day 13
Safety endpoints include the results of clinical laboratory tests
Measured: Day 1 to Day 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study start26 Jan 2017
- Primary completion27 Feb 2017
- Study completion27 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03004768
- Sponsor's protocol ID
- IM011-016
- Status last verified
- Feb 2018
- First submitted
- 19 Dec 2016
- Last updated
- 12 Feb 2018
- 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 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Metabolism of [14C]BMS-986165 in Healthy Male Participants
- ClinicalTrials.gov ID
- NCT03004768
- Acronym / sponsor ID
- IM011-016
- Conditions
- Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Covance
- Study start
- 26 Jan 2017 (actual)
- Primary completion
- 27 Feb 2017 (actual)
- Study completion
- 27 Feb 2017 (actual)
- First posted
- 29 Dec 2016 (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.
An oral dose in healthy subjects to obtain information about the absorption, metabolism, and excretion (AME) of BMS-986165
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single dose of radiolabeled BMS-986165 | Experimental | Drug: BMS-986165 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Signed Informed Consent
- Target population: Healthy males with no clinically significant deviations from normal in medical history, physical examinations, vital signs, electrocardiograms (ECGs), physical measurements, and clinical laboratory tests
- Body weight of at least 50 kilograms (110 pounds); body mass index (BMI) between 18 to 32 kg/m2.
- No evidence of acute infection or other significant problem as determined from a review of a chest x-ray, medical history, and physical examination
Key exclusion criteria (5 listed)
- History of any chronic or acute illness including active TB in the last 3 years, recent infection, gastrointestinal disease, smoking within less than 6 months prior to dosing, alcohol abuse, inability to tolerate oral medication, or inability to be venipunctured.
- Vaccination or plans for vaccination with any live vaccine 12 weeks prior to first dose of study drug, during the course of the study
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiograms, or clinical laboratory determinations beyond what is consistent with the target population.
- Participant with greater than Grade 2 acne.
- Participated in a radiolabeled drug study within the previous 12 months; clinically significant diagnostic or therapeutic radiation exposure within the previous 12 months; or current employment in a job requiring radiation exposure monitoring.
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-986165Oral solution dose of 24 mg [14C] BMS-986165 containing approximately 100 micro Ci of TRA | Drug | Single dose of radiolabeled BMS-986165 |
Primary outcome
The primary endpoint is PK exposure that will be determined from plasma concentration versus time
Time frame: Day 1 to Day 13
Urinary/fecal TRA (Total radioactivity) recovery data
Time frame: Day 1 to Day 13
PK terminal elimination half-life data (T-HALF)
Time frame: Day 1 to Day 13
PK apparent total body clearance (CL/F)
Time frame: Day 1 to Day 13
PK apparent volume of distribution (Vz/F)
Time frame: Day 1 to Day 13
PK time of maximum observed plasma concentration (Tmax)
Time frame: Day 1 to Day 13
5 secondary outcomes
Safety endpoints include the incidence of adverse events (AEs)
Time frame: Day 1 to Day 13
Safety endpoints include the results of electrocardiogram tests (ECGs)
Time frame: Day 1 to Day 13
Safety endpoints include the results of vital signs
Time frame: Day 1 to Day 13
Safety endpoints include the results of physical exams
Time frame: Day 1 to Day 13
Safety endpoints include the results of clinical laboratory tests
Time frame: Day 1 to Day 13
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 12 Feb 2018.
- 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-986165 in people with Psoriasis, 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 4 inclusion and 5 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 12 Feb 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 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?
The primary endpoint is PK exposure that will be determined from plasma concentration versus time (time frame: Day 1 to Day 13). The study lists 6 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 12 Feb 2018.