Healthy ParticipantsPhase 1NCT05409157
A Study to Evaluate the Drug Levels of BMS-986166 in Healthy Male Participants
A Phase 1 study testing BMS-986166 and Bisacodyl in people with Healthy Participants, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to assess the drug levels of BMS-986166 in healthy male participants. 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
- Healthy Participants
- What is being tested?
- BMS-986166 and Bisacodyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2022to 15 Oct 2022
- 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
- Healthy male participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECGs, or clinical laboratory determinations
- Body mass index between 18.0 to 33.0 kg/m2 (inclusive)
Who cannot join
- Any significant acute or chronic medical illness
- Current or recent history of constipation or irregular bowel movement (less than 1 bowel movement per day within the last 1 week)
- History of allergy (such as rash, hives, breathing difficulties) to any medications, either prescription or nonprescription
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
United States1 site
Local Institution - 0001
Madison, Wisconsin, 53704-2526
About this study
Official title: A Phase 1, Single-center, Open-label Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of [14C] BMS-986166 in Healthy Male Participants
The purpose of this study is to assess the drug levels of BMS-986166 in healthy male participants.
- Conditions
- Healthy Participants
- Being tested
- BMS-986166, Bisacodyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986166Drug
Specified dose on specified days
BisacodylDrug
Also called Dulcolax®
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group 1: BMS-986166 | Experimental | Not described Receives: Drug: BMS-986166; Drug: Bisacodyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount of total radioactivity (TRA) recovered in urine (UR)
Measured: Up to 90 days
Total amount of TRA recovered in feces (FR)
Measured: Up to 90 days
Total amount of TRA recovered in urine and feces combined (RTotal)
Measured: Up to 90 days
Percent of TRA recovered in urine (%UR)
Measured: Up to 90 days
Percent of TRA recovered in feces (%FR)
Measured: Up to 90 days
Percent of TRA recovered in urine and feces combined (%TOTAL)
Measured: Up to 90 days
Maximum observed concentration (Cmax)
Measured: Up to 89 days
Time of maximum observed concentration (Tmax)
Measured: Up to 89 days
Area under the concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)]
Measured: Up to 89 days
Secondary outcomes (9)
Number of participants with adverse events (AEs)
Measured: Up to 124 days
Number of participants with serious adverse events (SAEs)
Measured: Up to 124 days
Number of participants with vital sign abnormalities
Measured: Up to 90 days
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to 90 days
Number of participants with physical examination abnormalities
Measured: Up to 90 days
Number of participants with clinical laboratory test abnormalities
Measured: Up to 90 days
Maximum observed concentration (Cmax)
Measured: Up to 89 days
Time of maximum observed concentration (Tmax)
Measured: Up to 89 days
Area under the concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)]
Measured: Up to 89 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start17 Jun 2022
- Primary completion15 Oct 2022
- Study completion15 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 7 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
- NCT05409157
- Sponsor's protocol ID
- IM018-010
- Status last verified
- Mar 2023
- First submitted
- 3 Jun 2022
- Last updated
- 22 Mar 2023
- 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 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-center, Open-label Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of [14C] BMS-986166 in Healthy Male Participants
- ClinicalTrials.gov ID
- NCT05409157
- Acronym / sponsor ID
- IM018-010
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2022 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 15 Oct 2022 (actual)
- First posted
- 8 Jun 2022 (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 assess the drug levels of BMS-986166 in healthy male participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group 1: BMS-986166 | Experimental | Drug: BMS-986166, Drug: Bisacodyl |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECGs, or clinical laboratory determinations
- Body mass index between 18.0 to 33.0 kg/m2 (inclusive)
Key exclusion criteria (4 listed)
- Any significant acute or chronic medical illness
- Current or recent history of constipation or irregular bowel movement (less than 1 bowel movement per day within the last 1 week)
- History of allergy (such as rash, hives, breathing difficulties) to any medications, either prescription or nonprescription
- Other protocol-defined inclusion/exclusion criteria 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-986166Specified dose on specified days | Drug | Treatment Group 1: BMS-986166 |
| BisacodylAlso: Dulcolax®Specified dose on specified days | Drug | Treatment Group 1: BMS-986166 |
Primary outcome
Total amount of total radioactivity (TRA) recovered in urine (UR)
Time frame: Up to 90 days
Total amount of TRA recovered in feces (FR)
Time frame: Up to 90 days
Total amount of TRA recovered in urine and feces combined (RTotal)
Time frame: Up to 90 days
Percent of TRA recovered in urine (%UR)
Time frame: Up to 90 days
Percent of TRA recovered in feces (%FR)
Time frame: Up to 90 days
Percent of TRA recovered in urine and feces combined (%TOTAL)
Time frame: Up to 90 days
Maximum observed concentration (Cmax)
Time frame: Up to 89 days
Time of maximum observed concentration (Tmax)
Time frame: Up to 89 days
Area under the concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)]
Time frame: Up to 89 days
9 secondary outcomes
Number of participants with adverse events (AEs)
Time frame: Up to 124 days
Number of participants with serious adverse events (SAEs)
Time frame: Up to 124 days
Number of participants with vital sign abnormalities
Time frame: Up to 90 days
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 90 days
Number of participants with physical examination abnormalities
Time frame: Up to 90 days
Number of participants with clinical laboratory test abnormalities
Time frame: Up to 90 days
Maximum observed concentration (Cmax)
Time frame: Up to 89 days
Time of maximum observed concentration (Tmax)
Time frame: Up to 89 days
Area under the concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)]
Time frame: Up to 89 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 22 Mar 2023.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink 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-986166 and Bisacodyl in people with Healthy Participants, 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 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 22 Mar 2023. 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?
Total amount of total radioactivity (TRA) recovered in urine (UR) (time frame: Up to 90 days). The study lists 9 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 22 Mar 2023.