Healthy Male VolunteersPhase 1NCT04086719
An Investigational Study to Determine the Drug Level Profile of BMS-986165 in Healthy Male Volunteers Following Transporter Inhibition.
A Phase 1 study testing BMS-986165 and Pyrimethamine in people with Healthy Male Volunteers, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
Study of what the body does to drug BMS-986165 when it is taken together with pyrimethamine 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
- Healthy Male Volunteers
- What is being tested?
- BMS-986165 and Pyrimethamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2019to 29 Oct 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients must be willing and able to complete all study-specific procedures and visits
- Healthy patients, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram, and clinical laboratory determinations
- Body mass index (BMI) of 18 to 32 kg/m2, inclusive, at screening
- Normal renal function at screening
Who cannot join
- Any medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease
- Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug
- History or presence of clinically significant acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months prior to screening
- Additional criteria may apply
Trial locations and contacts
1 site in 1 country.
United States1 site
PRA Health Sciences - Salt Lake
Salt Lake City, Utah, 84124
About this study
Official title: An Open-Label, Single Sequence, Crossover Study to Investigate the Effects of OCT1 Inhibition Utilizing Pyrimethamine on Pharmacokinetics of BMS-986165 in Healthy Male Volunteers.
Study of what the body does to drug BMS-986165 when it is taken together with pyrimethamine
- Conditions
- Healthy Male Volunteers
- Being tested
- BMS-986165, Pyrimethamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986165Drug
Oral administration of tablet BMS- 986165
PyrimethamineDrug
Oral administration of Pyrimethamine in combination with BMS-986185
| Study group | Role | What they receive |
|---|---|---|
| BMS- 986185 + Pyrimethamine | Experimental | Not described Receives: Drug: Pyrimethamine |
| BMS-986185 | Experimental | Not described Receives: Drug: BMS-986165 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed serum comcentration (Cmax)
Measured: Day 1, Day 5
Area under the concentration-time curve from time zero extrapolated to AUC(INF)
Measured: Day 1, Day 5
Secondary outcomes (7)
Incidences of Adverse Events (AE's)
Measured: Approximetly 20 days
Time of maximum observed concentration (Tmax)
Measured: Approxmiately 20 days
Half- life time (T-Half)
Measured: Day 1, Day 5
Apparent oral clearance (CL/F)
Measured: Day 5
Apparent volume of distribution at terminal phase (Vz/F)
Measured: Day 5
Ratio of metabolite AUC(0-T) to parent AUC(0-T) corrected for Molecular weight MRAUC(0-T)
Measured: Day 5
Ratio of metabolite AUC(INF) to parent AUC(INF) corrected for Moecular weight MRAUC(INF)
Measured: Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start12 Sep 2019
- Primary completion29 Oct 2019
- Study completion29 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male VolunteersStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086719
- Sponsor's protocol ID
- IM011-100
- Status last verified
- Aug 2020
- First submitted
- 10 Sep 2019
- Last updated
- 5 Aug 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 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single Sequence, Crossover Study to Investigate the Effects of OCT1 Inhibition Utilizing Pyrimethamine on Pharmacokinetics of BMS-986165 in Healthy Male Volunteers.
- ClinicalTrials.gov ID
- NCT04086719
- Acronym / sponsor ID
- IM011-100
- Conditions
- Healthy Male Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2019 (actual)
- Primary completion
- 29 Oct 2019 (actual)
- Study completion
- 29 Oct 2019 (actual)
- First posted
- 12 Sep 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.
Study of what the body does to drug BMS-986165 when it is taken together with pyrimethamine
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMS- 986185 + Pyrimethamine | Experimental | Drug: Pyrimethamine |
| BMS-986185 | 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)
- Patients must be willing and able to complete all study-specific procedures and visits
- Healthy patients, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram, and clinical laboratory determinations
- Body mass index (BMI) of 18 to 32 kg/m2, inclusive, at screening
- Normal renal function at screening
Key exclusion criteria (4 listed)
- Any medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease
- Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug
- History or presence of clinically significant acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months prior to screening
- Additional criteria may 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 of tablet BMS- 986165 | Drug | BMS-986185 |
| PyrimethamineOral administration of Pyrimethamine in combination with BMS-986185 | Drug | BMS- 986185 + Pyrimethamine |
Primary outcome
Maximum observed serum comcentration (Cmax)
Time frame: Day 1, Day 5
Area under the concentration-time curve from time zero extrapolated to AUC(INF)
Time frame: Day 1, Day 5
7 secondary outcomes
Incidences of Adverse Events (AE's)
Time frame: Approximetly 20 days
Time of maximum observed concentration (Tmax)
Time frame: Approxmiately 20 days
Half- life time (T-Half)
Time frame: Day 1, Day 5
Apparent oral clearance (CL/F)
Time frame: Day 5
Apparent volume of distribution at terminal phase (Vz/F)
Time frame: Day 5
Ratio of metabolite AUC(0-T) to parent AUC(0-T) corrected for Molecular weight MRAUC(0-T)
Time frame: Day 5
Ratio of metabolite AUC(INF) to parent AUC(INF) corrected for Moecular weight MRAUC(INF)
Time frame: Day 5
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 Aug 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pyrimethamine in people with Healthy Male Volunteers, 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 4 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 Aug 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 observed serum comcentration (Cmax) (time frame: Day 1, Day 5). 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 5 Aug 2020.