PsoriasisPhase 1NCT03873415
Assessment of Gut Absorption of Experimental Medication BMS-986165 in Healthy Males
A Phase 1 study testing BMS-986165 in people with Psoriasis, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to evaluate sites of gut absorption of BMS-986165 in males Read more about this study
- Who is it for?
- Ages 18 to 45 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
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2019to 1 May 2019
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index of 18.0 to 32.0 kg/m2, inclusive, and weight ≥ 50 kg, at screening
- Estimated glomerular filtration rate (eGFR) > 80 mL/min/1.732 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula
Who cannot join
- Any significant acute or chronic medical illness
- Current or recent (within 3 months of study drug administration) disease of the gut that, in the opinion of the Investigator or Medical Monitor, could impact upon the absorption of study drug
- Acute diarrhea, or constipation within 3 weeks prior to randomization
- Any major surgery within 4 weeks of randomization
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Regional Gastrointestinal Absorption of BMS-986165 Using Pharmacoscintigraphic Evaluation in Healthy Male Subjects
The purpose of this study is to evaluate sites of gut absorption of BMS-986165 in males
- 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 administration
| Study group | Role | What they receive |
|---|---|---|
| Formulation A | Experimental | Dosage formulation and area of release varies between arms Receives: Drug: BMS-986165 |
| Formulation B | Experimental | Dosage formulation and area of release varies between arms Receives: Drug: BMS-986165 |
| Formulation C | Experimental | Dosage formulation and area of release varies between arms Receives: Drug: BMS-986165 |
| Formulation D | Experimental | Dosage formulation and area of release varies between arms Receives: Drug: BMS-986165 |
| Formulation E | Experimental | Dosage formulation and area of release varies between arms Receives: Drug: BMS-986165 |
| Formulation F | Experimental | Dosage formulation and area of release varies between arms Receives: Drug: BMS-986165 |
| Formulation G | Experimental | Dosage formulation and area of release varies between arms Receives: Drug: BMS-986165 |
| Formulation H | Experimental | Dosage formulation and area of release varies between arms Receives: 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) of BMS-986165 following Treatments A, B, C, and D
Measured: Determined over 5 days
Time of maximum observed plasma concentration (Tmax) of BMS-986165 following Treatments A, B, C, and D
Measured: Determined over 5 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986165 following Treatments A, B, C, and D
Measured: Determined over 5 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986165 following Treatments A, B, C, and D
Measured: Determined over 5 days
Apparent plasma elimination half-life (T-HALF) of BMS-986165 following Treatments A, B, C, and D
Measured: Determined over 5 days
Secondary outcomes (7)
Vital signs of body temperature
Measured: Up to 60 days
Pulse rate
Measured: Up to 60 days
Physical examination
Measured: Up to 60 days
Incidence of adverse events (AE)
Measured: Up to 90 days
Incidence of serious adverse events (SAE)
Measured: Up to 90 days
Vital sign of respiratory rate
Measured: Up to 60 days
Vital sign of supine blood pressure
Measured: Up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start25 Jan 2019
- Primary completion1 May 2019
- Study completion1 May 2019
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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 9 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
- NCT03873415
- Sponsor's protocol ID
- IM011-019
- Status last verified
- Nov 2019
- First submitted
- 4 Feb 2019
- Last updated
- 26 Nov 2019
- 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 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Regional Gastrointestinal Absorption of BMS-986165 Using Pharmacoscintigraphic Evaluation in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03873415
- Acronym / sponsor ID
- IM011-019
- Conditions
- Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 13 Mar 2019 (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 evaluate sites of gut absorption of BMS-986165 in males
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Formulation A | Experimental | Drug: BMS-986165Dosage formulation and area of release varies between arms |
| Formulation B | Experimental | Drug: BMS-986165Dosage formulation and area of release varies between arms |
| Formulation C | Experimental | Drug: BMS-986165Dosage formulation and area of release varies between arms |
| Formulation D | Experimental | Drug: BMS-986165Dosage formulation and area of release varies between arms |
| Formulation E | Experimental | Drug: BMS-986165Dosage formulation and area of release varies between arms |
| Formulation F | Experimental | Drug: BMS-986165Dosage formulation and area of release varies between arms |
| Formulation G | Experimental | Drug: BMS-986165Dosage formulation and area of release varies between arms |
| Formulation H | Experimental | Drug: BMS-986165Dosage formulation and area of release varies between arms |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index of 18.0 to 32.0 kg/m2, inclusive, and weight ≥ 50 kg, at screening
- Estimated glomerular filtration rate (eGFR) > 80 mL/min/1.732 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula
Key exclusion criteria (5 listed)
- Any significant acute or chronic medical illness
- Current or recent (within 3 months of study drug administration) disease of the gut that, in the opinion of the Investigator or Medical Monitor, could impact upon the absorption of study drug
- Acute diarrhea, or constipation within 3 weeks prior to randomization
- Any major surgery within 4 weeks of randomization
- Other protocol defined inclusion/exclusion criteria could apply
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 administration | Drug | Formulation A, Formulation B, Formulation C, Formulation D, Formulation E, Formulation F, Formulation G, Formulation H |
Primary outcome
Maximum observed plasma concentration (Cmax) of BMS-986165 following Treatments A, B, C, and D
Time frame: Determined over 5 days
Time of maximum observed plasma concentration (Tmax) of BMS-986165 following Treatments A, B, C, and D
Time frame: Determined over 5 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986165 following Treatments A, B, C, and D
Time frame: Determined over 5 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986165 following Treatments A, B, C, and D
Time frame: Determined over 5 days
Apparent plasma elimination half-life (T-HALF) of BMS-986165 following Treatments A, B, C, and D
Time frame: Determined over 5 days
7 secondary outcomes
Vital signs of body temperature
Time frame: Up to 60 days
Pulse rate
Time frame: Up to 60 days
Physical examination
Time frame: Up to 60 days
Incidence of adverse events (AE)
Time frame: Up to 90 days
Incidence of serious adverse events (SAE)
Time frame: Up to 90 days
Vital sign of respiratory rate
Time frame: Up to 60 days
Vital sign of supine blood pressure
Time frame: Up to 60 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 26 Nov 2019.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- 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 2 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 26 Nov 2019. 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 observed plasma concentration (Cmax) of BMS-986165 following Treatments A, B, C, and D (time frame: Determined over 5 days). The study lists 5 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 26 Nov 2019.