PsoriasisPhase 1NCT03419910
An Investigational Study of Cyclosporine on Experimental Medication BMS-986165 in Healthy Male Participants
A Phase 1 study testing BMS-986165 and Cyclosporine in people with Psoriasis, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
This is an investigational study of Cyclosporine on the experimental medication BMS-986165 in healthy male participants. 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 and Cyclosporine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2018to 4 May 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
- Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- Body mass index 18.0 to 32.0 kg/m2
- Weight ≥ 50 kg
Who cannot join
- Any medical condition that presents a potential risk to the subject and/or may compromise the objectives of the study, including a history of or active liver disease
- History or presence of acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months prior to screening
- Known or suspected autoimmune disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status
- History of administration of live vaccines within 60 days before screening
- Any history or risk for tuberculosis (TB)
- 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 Cyclosporine on the Pharmacokinetics of BMS-986165 at Steady State in Healthy Male Participants
This is an investigational study of Cyclosporine on the experimental medication BMS-986165 in healthy male participants.
- Conditions
- Psoriasis
- Being tested
- BMS-986165, Cyclosporine
- 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
Specified dose on specified days
CyclosporineDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| BMS-986165 and cyclosporine | Experimental | BMS-986165 and cyclosporine administered orally Receives: Drug: BMS-986165; Drug: Cyclosporine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration (Cmax)
Measured: 24 hours
Area under the concentration vs time curve from time zero to 24 hours post dose (AUC[0-24])
Measured: 24 hours
Secondary outcomes (1)
Adverse events (AEs)
Measured: Up to 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start5 Mar 2018
- Primary completion4 May 2018
- Study completion4 May 2018
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
- 54 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
- NCT03419910
- Sponsor's protocol ID
- IM011-045
- Status last verified
- Mar 2020
- First submitted
- 29 Jan 2018
- Last updated
- 18 Mar 2020
- 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 18 Mar 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 Cyclosporine on the Pharmacokinetics of BMS-986165 at Steady State in Healthy Male Participants
- ClinicalTrials.gov ID
- NCT03419910
- Acronym / sponsor ID
- IM011-045
- Conditions
- Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 4 May 2018 (actual)
- Study completion
- 4 May 2018 (actual)
- First posted
- 5 Feb 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.
This is an investigational study of Cyclosporine on the experimental medication BMS-986165 in healthy male participants.
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 and cyclosporine | Experimental | Drug: BMS-986165, Drug: CyclosporineBMS-986165 and cyclosporine administered orally |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- Body mass index 18.0 to 32.0 kg/m2
- Weight ≥ 50 kg
Key exclusion criteria (6 listed)
- Any medical condition that presents a potential risk to the subject and/or may compromise the objectives of the study, including a history of or active liver disease
- History or presence of acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months prior to screening
- Known or suspected autoimmune disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status
- History of administration of live vaccines within 60 days before screening
- Any history or risk for tuberculosis (TB)
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-986165Specified dose on specified days | Drug | BMS-986165 and cyclosporine |
| CyclosporineSpecified dose on specified days | Drug | BMS-986165 and cyclosporine |
Primary outcome
Maximum concentration (Cmax)
Time frame: 24 hours
Area under the concentration vs time curve from time zero to 24 hours post dose (AUC[0-24])
Time frame: 24 hours
1 secondary outcome
Adverse events (AEs)
Time frame: Up to 20 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 18 Mar 2020.
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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 and Cyclosporine 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 3 inclusion and 6 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 18 Mar 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 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 concentration (Cmax) (time frame: 24 hours). The study lists 2 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 18 Mar 2020.