ThrombosisPhase 1NCT03196206
Evaluate Pharmacokinetics and Safety of BMS-986177 in Participants With Normal Renal Function and With Moderate or Severe Renal Impairment
A Phase 1 study testing BMS-986177 in people with Thrombosis, run by Bristol-Myers Squibb at 3 sites in United States.
Trial summary
Assess the pharmacokinetics, safety, and tolerability of a single dose of BMS-986177 in participants with normal renal function and moderate to severe renal impairment. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy 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
- 24 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Jul 2017to 4 Mar 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants in Groups B and C will be classified by renal function by eGRF at screening and confirmed on Day -1
- Participants in Group A will be healthy participants as determined by no significant deviations in normal medical and surgical history and assessments
- Participants in Group A must have a body mass index of 18.0 to 32.0 kg/m2, inclusive
- Females must be of non-childbearing potential
Who cannot join
- Participants in Groups B and C cannot have an indwelling catheter for hemodialysis
- Participants in Groups B and C cannot have had, nor be waiting for, an organ transplant
- Other protocol defined inclusion and exclusion criteria could apply
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Clinical Pharmacology Of Miami Inc.
Miami, Florida, 33014
Clinical Pharmacology of Miami LLC
Miami, Florida, 33014
Orlando Clinical Research Center
Orlando, Florida, 32809
About this study
Official title: An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of BMS- 986177 in Participants With Normal Renal Function and Participants With Moderate and Severe Renal Impairment
Assess the pharmacokinetics, safety, and tolerability of a single dose of BMS-986177 in participants with normal renal function and moderate to severe renal impairment.
- 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
Oral Suspension
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Normal Renal Function Receives: Drug: BMS-986177 |
| Group B | Experimental | Moderate Renal Impairment Receives: Drug: BMS-986177 |
| Group C | Experimental | Severe Renal Impairment Receives: Drug: BMS-986177 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
Measured by plasma concentration
Measured: Up to 5 days
AUC from time zero to time of last quantifiable concentration (AUC (0-T))
Summary measures of PK parameters
Measured: Up to 5 days
AUC from time zero extrapolated to infinite time (AUC (INF))
Summary measures of PK parameters
Measured: Up to 5 days
Secondary outcomes (5)
Incidence of Adverse Events (AEs)
Safety and tolerability as measured by incidence of AEs
Measured: Up to 5 days
Incidence of Serious Adverse Events ( SAEs)
Safety and tolerability as measured by incidence of SAEs
Measured: Up to 30 days
Change from baseline in electrocardiogram findings
Measured by investigator assessment
Measured: Up to 5 days
Change from baseline in physical examination findings
Measured by investigator assessment
Measured: Up to 5 days
Change from baseline in clinical laboratory test findings
Measured by investigator assessment
Measured: Up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start13 Jul 2017
- Primary completion4 Mar 2018
- Study completion4 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT03196206
- Sponsor's protocol ID
- CV010-018
- Status last verified
- Jun 2022
- First submitted
- 21 Jun 2017
- Last updated
- 10 Jun 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Perera V, Abelian G, Li D, Wang Z, Zhang L, Lubin S, Bello A, Murthy B. Single-Dose Pharmacokinetics of Milvexian in Participants with Normal Renal Function and Participants with Moderate or Severe Renal Impairment. Clin Pharmacokinet. 2022 Oct;61(10):1405-1416. doi: 10.1007/s40262-022-01150-1. Epub 2022 Jul 30.
PubMed 35906349
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of BMS- 986177 in Participants With Normal Renal Function and Participants With Moderate and Severe Renal Impairment
- ClinicalTrials.gov ID
- NCT03196206
- Acronym / sponsor ID
- CV010-018
- Conditions
- Thrombosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2017 (actual)
- Primary completion
- 4 Mar 2018 (actual)
- Study completion
- 4 Mar 2018 (actual)
- First posted
- 22 Jun 2017 (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.
Assess the pharmacokinetics, safety, and tolerability of a single dose of BMS-986177 in participants with normal renal function and moderate to severe renal impairment.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: BMS-986177Normal Renal Function |
| Group B | Experimental | Drug: BMS-986177Moderate Renal Impairment |
| Group C | Experimental | Drug: BMS-986177Severe Renal Impairment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants in Groups B and C will be classified by renal function by eGRF at screening and confirmed on Day -1
- Participants in Group A will be healthy participants as determined by no significant deviations in normal medical and surgical history and assessments
- Participants in Group A must have a body mass index of 18.0 to 32.0 kg/m2, inclusive
- Females must be of non-childbearing potential
Key exclusion criteria (3 listed)
- Participants in Groups B and C cannot have an indwelling catheter for hemodialysis
- Participants in Groups B and C cannot have had, nor be waiting for, an organ transplant
- Other protocol defined inclusion and 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-986177Oral Suspension | Drug | Group A, Group B, Group C |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Up to 5 days
Measured by plasma concentration
AUC from time zero to time of last quantifiable concentration (AUC (0-T))
Time frame: Up to 5 days
Summary measures of PK parameters
AUC from time zero extrapolated to infinite time (AUC (INF))
Time frame: Up to 5 days
Summary measures of PK parameters
5 secondary outcomes
Incidence of Adverse Events (AEs)
Time frame: Up to 5 days
Incidence of Serious Adverse Events ( SAEs)
Time frame: Up to 30 days
Change from baseline in electrocardiogram findings
Time frame: Up to 5 days
Change from baseline in physical examination findings
Time frame: Up to 5 days
Change from baseline in clinical laboratory test findings
Time frame: Up to 5 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 10 Jun 2022.
- Derived from this study: PubMed 35906349Perera V, Abelian G, Li D, Wang Z, Zhang L, Lubin S, Bello A, Murthy B. Single-Dose Pharmacokinetics of Milvexian in Participants with Normal Renal Function and Participants with Moderate or Severe Renal Impairment. Clin Pharmacokinet. 2022 Oct;61(10):1405-1416. doi: 10.1007/s40262-022-01150-1. Epub 2022 Jul 30.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Investigator Inquiry FormLink 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
3 sites 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 3 sites 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 3 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 10 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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) (time frame: Up to 5 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03196206, which also lists 1 linked publication.
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 10 Jun 2022.