ThrombosisPhase 1NCT03939702
Pharmacokinetic and Metabolism of [14^C] BMS-986177 in Healthy Male Participants
A Phase 1 study testing BMS-986177 in people with Thrombosis, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
This is an ADME study. Human radiolabeled mass balance studies are performed as part of drug development to obtain information about the absorption, distribution, metabolism, and excretion (ADME) of a study treatment. 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
- Thrombosis
- What is being tested?
- BMS-986177
- 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
- 2 May 2019to 11 Jul 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
- Signed ICF
- Healthy Male
- Body mass index of 18.0 to 32.0 kg/m2, inclusive.
- Agreement to use approved contraception for 94 days post treatment
- Agreement to not donate sperm for 94 days post treatment
Who cannot join
- Acute or chronic illness
- GI disease current or recent
- History of dizziness or recurring headaches
- Head injury within last 2 years
- GI surgery
- History or evidence of abnormal bleeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit, Inc.
Madison, Wisconsin, 53704
About this study
This is an ADME study. Human radiolabeled mass balance studies are performed as part of drug development to obtain information about the absorption, distribution, metabolism, and excretion (ADME) of a study treatment. The goals of human ADME studies include the assessment of absorption, distribution, routes and rates of excretion, mass balance, and metabolite profile and identification.
- Conditions
- Thrombosis
- Being tested
- BMS-986177
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986177Drug
An orally administered anticoagulant to prevent and treat thromboembolic events
| Study group | Role | What they receive |
|---|---|---|
| Non-Bile Collection | Active comparator | On Day 1, all participants will receive a single oral solution dose of 200 mg [14C] BMS-986177 containing approximately 88 micro Ci of total radioactivity (TRA). Participants will remain in the clinical facility until at least Day 7 and will be discharged when release criteria are met or until Day 12 Receives: Drug: BMS-986177 |
| Bile Collection | Active comparator | On Day 1, all participants will receive a single oral solution dose of 200 mg [14C] BMS-986177 containing approximately 88 micro Ci of total radioactivity (TRA). Approximately 1 hour after study drug administration, an ND tube may be positioned in approximately 3 selected participants for collection of bile.Participants will remain in the clinical facility until at least Day 7 and will be discharged when release criteria are met or until Day 12 Receives: Drug: BMS-986177 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess PK Cmax of a dose of [14C]BMS-986177
Cmax
Measured: Day 1-12
Assess PK AUC(INF) of a dose of [14C]BMS-986177
AUC(INF)
Measured: Day 1-12
Assess PK AUC(0-T) of a dose of [14C]BMS-986177
AUC(0-T)
Measured: Day 1-12
Assess PK Tmax of a dose of [14C]BMS-986177
Tmax
Measured: Day 1-12
Assess PK T-HALF of a dose of [14C]BMS-986177
T-HALF
Measured: Day 1-12
Assess PK CL/F of a dose of [14C]BMS-986177
Measured: Day 1-12
Assess PK Vz/F of a dose of [14C]BMS-986177
Vz/F
Measured: Day 1-12
Assess PK AUC of a dose of [14C]BMS-986177
AUC(BMS-986177)
Measured: Day 1-12
Assess PK AUC(TRA) of a dose of [14C]BMS-986177
AUC(TRA)
Measured: Day 1-12
Assess PK Plasma AUC(TRA) of a dose of [14C]BMS-986177
Plasma AUC(TRA)
Measured: Day 1-12
Assess PK Blood AUC(TRA) of a dose of [14C]BMS-986177
Blood AUC(TRA)
Measured: Day 1-12
Assess the CLR of [14C]BMS-986177
CLR
Measured: Day 1-12
Assess the %UR of [14C]BMS-986177
%UR
Measured: Day 1-12
Assess the %FE of [14C]BMS-986177
%FE
Measured: Day 1-12
Assess the %BE of [14C]BMS-986177
%BE (if applicable)
Measured: Day 1-12
Assess the %Total recovery of [14C]BMS-986177
%Total recovery
Measured: Day 1-12
Secondary outcomes (6)
Asess the Incidence of AEs of a single oral dose of 200 mg [14C] BMS-986177
Incidence of AEs
Measured: Day 1-12
Asess the Incidence of SAEs of a single oral dose of 200 mg [14C] BMS-986177
Incidence of SAEs
Measured: Day 1-12
Asess the Incidence of AEs leading to discontinuation of a single oral dose of 200 mg [14C] BMS-986177
Incidence of AEs leading to discontinuation
Measured: Day 1-12
Assess the vital signs of a subject dosed with single oral dose of 200 mg [14C] BMS-986177
results of vital sign examination
Measured: Day 1-12
Assess the ECGs of subjects dosed with single oral dose of 200 mg [14C] BMS-986177
ECG physical examinations
Measured: Day 1-12
Assess the clinical lab tests of a single oral dose of 200 mg [14C] BMS-986177
Results of Clinical laboratory tests
Measured: Day 1-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start2 May 2019
- Primary completion11 Jul 2019
- Study completion11 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombosisStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939702
- Sponsor's protocol ID
- CV010-036
- Status last verified
- Aug 2019
- First submitted
- 2 May 2019
- Last updated
- 4 Oct 2019
- 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 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic and Metabolism of [14^C] BMS-986177 in Healthy Male Participants
- ClinicalTrials.gov ID
- NCT03939702
- Acronym / sponsor ID
- CV010-036
- Conditions
- Thrombosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 2 May 2019 (actual)
- Primary completion
- 11 Jul 2019 (actual)
- Study completion
- 11 Jul 2019 (actual)
- First posted
- 7 May 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.
This is an ADME study. Human radiolabeled mass balance studies are performed as part of drug development to obtain information about the absorption, distribution, metabolism, and excretion (ADME) of a study treatment. The goals of human ADME studies include the assessment of absorption, distribution, routes and rates of excretion, mass balance, and metabolite profile and identification.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Bile Collection | Active comparator | Drug: BMS-986177On Day 1, all participants will receive a single oral solution dose of 200 mg [14C] BMS-986177 containing approximately 88 micro Ci of total radioactivity (TRA). Participants will remain in the clinical facility until at least Day 7 and will be discharged when release criteria are met or until Day 12 |
| Bile Collection | Active comparator | Drug: BMS-986177On Day 1, all participants will receive a single oral solution dose of 200 mg [14C] BMS-986177 containing approximately 88 micro Ci of total radioactivity (TRA). Approximately 1 hour after study drug administration, an ND tube may be positioned in approximately 3 selected participants for collection of bile.Participants will remain in the clinical facility until at least Day 7 and will be discharged when release criteria are met or until Day 12 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Signed ICF
- Healthy Male
- Body mass index of 18.0 to 32.0 kg/m2, inclusive.
- Agreement to use approved contraception for 94 days post treatment
- Agreement to not donate sperm for 94 days post treatment
Key exclusion criteria (6 listed)
- Acute or chronic illness
- GI disease current or recent
- History of dizziness or recurring headaches
- Head injury within last 2 years
- GI surgery
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-986177An orally administered anticoagulant to prevent and treat thromboembolic events | Drug | Bile Collection, Non-Bile Collection |
Primary outcome
Assess PK Cmax of a dose of [14C]BMS-986177
Time frame: Day 1-12
Cmax
Assess PK AUC(INF) of a dose of [14C]BMS-986177
Time frame: Day 1-12
AUC(INF)
Assess PK AUC(0-T) of a dose of [14C]BMS-986177
Time frame: Day 1-12
AUC(0-T)
Assess PK Tmax of a dose of [14C]BMS-986177
Time frame: Day 1-12
Tmax
Assess PK T-HALF of a dose of [14C]BMS-986177
Time frame: Day 1-12
T-HALF
Assess PK CL/F of a dose of [14C]BMS-986177
Time frame: Day 1-12
Assess PK Vz/F of a dose of [14C]BMS-986177
Time frame: Day 1-12
Vz/F
Assess PK AUC of a dose of [14C]BMS-986177
Time frame: Day 1-12
AUC(BMS-986177)
Assess PK AUC(TRA) of a dose of [14C]BMS-986177
Time frame: Day 1-12
AUC(TRA)
Assess PK Plasma AUC(TRA) of a dose of [14C]BMS-986177
Time frame: Day 1-12
Plasma AUC(TRA)
Assess PK Blood AUC(TRA) of a dose of [14C]BMS-986177
Time frame: Day 1-12
Blood AUC(TRA)
Assess the CLR of [14C]BMS-986177
Time frame: Day 1-12
CLR
Assess the %UR of [14C]BMS-986177
Time frame: Day 1-12
%UR
Assess the %FE of [14C]BMS-986177
Time frame: Day 1-12
%FE
Assess the %BE of [14C]BMS-986177
Time frame: Day 1-12
%BE (if applicable)
Assess the %Total recovery of [14C]BMS-986177
Time frame: Day 1-12
%Total recovery
6 secondary outcomes
Asess the Incidence of AEs of a single oral dose of 200 mg [14C] BMS-986177
Time frame: Day 1-12
Asess the Incidence of SAEs of a single oral dose of 200 mg [14C] BMS-986177
Time frame: Day 1-12
Asess the Incidence of AEs leading to discontinuation of a single oral dose of 200 mg [14C] BMS-986177
Time frame: Day 1-12
Assess the vital signs of a subject dosed with single oral dose of 200 mg [14C] BMS-986177
Time frame: Day 1-12
Assess the ECGs of subjects dosed with single oral dose of 200 mg [14C] BMS-986177
Time frame: Day 1-12
Assess the clinical lab tests of a single oral dose of 200 mg [14C] BMS-986177
Time frame: Day 1-12
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 4 Oct 2019.
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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-986177 in people with Thrombosis, 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 5 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 4 Oct 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?
Assess PK Cmax of a dose of [14C]BMS-986177 (time frame: Day 1-12). The study lists 16 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 4 Oct 2019.