Health ParticipantsPhase 1NCT04154800
A Study to Evaluate the Safety, Tolerability, Drug Levels and Drug Effects of Single and Multiple Doses of BMS-986209 in Healthy Participants
A Phase 1 study testing BMS-986209, Itraconazole and Diltiazem in people with Health Participants, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to investigate the safety and tolerability of BMS-986209 in healthy participants. The first-in-human study is designed in 3 parts that vary based on duration and food effect. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Participants
- What is being tested?
- BMS-986209, Itraconazole and Diltiazem
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2019to 31 Aug 2021
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female participants (not of childbearing potential) as determined by no deviation considered significant by the investigator from normal in medical history, physical examination, 12-lead ECG measurements, and clinical laboratory determinations
- Women and men must agree to follow specific methods of contraception if applicable.
- Body mass index (BMI) 18.0 to 32.0 kg/m2, inclusive. BMI = weight (kg)/(height [m])2 for participants
Who cannot join
- Women who are of childbearing potential
- Women who are breastfeeding
- Any acute or chronic medical illness
- History of dizziness and/or recurrent headaches (ie, daily headaches lasting for a 1-week duration in the last month prior to study treatment administration)
- History of heart disease or conduction disorders
- Head injury in the last 2 years, intracranial tumor, or aneurysm
Show all 9Show fewer
- Known abdominal aneurysm
- Current or history of rectal bleeding, hematemesis, or hematuria
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of BMS-986209 in Healthy Participants
The purpose of this study is to investigate the safety and tolerability of BMS-986209 in healthy participants. The first-in-human study is designed in 3 parts that vary based on duration and food effect.
- Conditions
- Health Participants
- Being tested
- BMS-986209, BMS-986209 Placebo, Itraconazole, Diltiazem
- Keywords
- Healthy Participants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986209Drug
Specified Dose on Specified Days
BMS-986209 PlaceboOther
Specified Dose on Specified Days
ItraconazoleDrug
Specified Dose on Specified Days
DiltiazemDrug
Specified Dose on Specified Days
| Study group | Role | What they receive |
|---|---|---|
| Part A:SAD | Experimental | Single Ascending Dose Receives: Drug: BMS-986209 |
| Part B: MAD | Experimental | Multiple Ascending Dose Receives: Drug: BMS-986209 |
| Part C: DDI | Experimental | Drug-Drug Interaction Receives: Drug: BMS-986209; Drug: Itraconazole; Drug: Diltiazem |
| Part A (SAD) Placebo | Experimental | Not described Receives: Other: BMS-986209 Placebo |
| Part B (MAD) Placebo | Experimental | Not described Receives: Other: BMS-986209 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs) including bleeding
Measured: Up to 18 days
Incidence of serious AEs (SAEs)
Measured: Up to 44 days
Incidence of AEs leading to discontinuation
Measured: Up to 18 days
Incidence of clinically significant changes in vital signs: Body temperature
Measured: Up to 18 days
Incidence of clinically significant changes in vital signs: Respiratory Rate
Measured: Up to 18 days
Incidence of clinically significant changes in vital signs: Seated blood pressure
Measured: Up to 18 days
Incidence of clinically significant changes in vital signs: Resting pulse rate
Measured: Up to 18 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters
Measured: Up to 18 days
Incidence of clinically significant changes in clinical laboratory tests: Hematology tests
Measured: Up to 16 days
Incidence of clinically significant changes in clinical laboratory tests: Coagulation tests
Measured: Up to 16 days
Incidence of clinically significant changes in clinical laboratory tests: Serum Chemistry tests
Measured: Up to 16 days
Incidence of clinically significant changes in clinical laboratory tests: Urinalysis tests
Measured: Up to 16 days
Incidence of clinically significant changes in clinical laboratory tests: Serology tests
Measured: Up to 16 days
Secondary outcomes (18)
Maximum observed plasma concentration (Cmax) of BMS-986209
Measured: Up to 18 days
Time of Maximum observed plasma concentration (Tmax) of BMS-986209
Measured: Up to 18 days
Terminal plasma half-life (T-Half) of BMS-986209
Measured: Up to 18 days
Incidence of Adverse Events (AEs) including bleeding
Measured: Up to 18 days
Incidence of serious AEs (SAEs)
Measured: Up to 44 days
Incidence of AEs leading to discontinuation
Measured: Up to 18 days
Incidence of clinically significant changes in vital signs: Body temperature
Measured: Up to 18 days
Incidence of clinically significant changes in vital signs: Respiratory Rate
Measured: Up to 18 days
Incidence of clinically significant changes in vital signs: Seated blood pressure
Measured: Up to 18 days
Incidence of clinically significant changes in vital signs: Resting pulse rate
Measured: Up to 18 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters
Measured: Up to 18 days
Incidence of clinically significant changes in clinical laboratory tests: Hematology tests
Measured: Up to 16 days
Incidence of clinically significant changes in clinical laboratory tests: Coagulation tests
Measured: Up to 16 days
Incidence of clinically significant changes in clinical laboratory tests: Serum Chemistry tests
Measured: Up to 16 days
Incidence of clinically significant changes in clinical laboratory tests: Urinalysis tests
Measured: Up to 16 days
Incidence of clinically significant changes in clinical laboratory tests: Serology tests
Measured: Up to 16 days
Percent change from baseline in plasma activated partial thromboplastin time (aPTT) levels
Measured: Up to 16 days
Percent change from baseline in factor XI (FXI) clotting activity
Measured: Up to 16 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start6 Dec 2019
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health 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
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 114 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
- NCT04154800
- Sponsor's protocol ID
- CV017-003
- Status last verified
- Dec 2021
- First submitted
- 5 Nov 2019
- Last updated
- 4 Jan 2022
- 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 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of BMS-986209 in Healthy Participants
- ClinicalTrials.gov ID
- NCT04154800
- Acronym / sponsor ID
- CV017-003
- Conditions
- Health Participants
- Keywords
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2019 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 7 Nov 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 investigate the safety and tolerability of BMS-986209 in healthy participants. The first-in-human study is designed in 3 parts that vary based on duration and food effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part A:SAD | Experimental | Drug: BMS-986209Single Ascending Dose |
| Part B: MAD | Experimental | Drug: BMS-986209Multiple Ascending Dose |
| Part C: DDI | Experimental | Drug: BMS-986209, Drug: Itraconazole, Drug: DiltiazemDrug-Drug Interaction |
| Part A (SAD) Placebo | Experimental | Other: BMS-986209 Placebo |
| Part B (MAD) Placebo | Experimental | Other: BMS-986209 Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male and female participants (not of childbearing potential) as determined by no deviation considered significant by the investigator from normal in medical history, physical examination, 12-lead ECG measurements, and clinical laboratory determinations
- Women and men must agree to follow specific methods of contraception if applicable.
- Body mass index (BMI) 18.0 to 32.0 kg/m2, inclusive. BMI = weight (kg)/(height [m])2 for participants
Key exclusion criteria (9 listed)
- Women who are of childbearing potential
- Women who are breastfeeding
- Any acute or chronic medical illness
- History of dizziness and/or recurrent headaches (ie, daily headaches lasting for a 1-week duration in the last month prior to study treatment administration)
- History of heart disease or conduction disorders
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-986209Specified Dose on Specified Days | Drug | Part A:SAD, Part B: MAD, Part C: DDI |
| BMS-986209 PlaceboSpecified Dose on Specified Days | Other | Part A (SAD) Placebo, Part B (MAD) Placebo |
| ItraconazoleSpecified Dose on Specified Days | Drug | Part C: DDI |
| DiltiazemSpecified Dose on Specified Days | Drug | Part C: DDI |
Primary outcome
Incidence of Adverse Events (AEs) including bleeding
Time frame: Up to 18 days
Incidence of serious AEs (SAEs)
Time frame: Up to 44 days
Incidence of AEs leading to discontinuation
Time frame: Up to 18 days
Incidence of clinically significant changes in vital signs: Body temperature
Time frame: Up to 18 days
Incidence of clinically significant changes in vital signs: Respiratory Rate
Time frame: Up to 18 days
Incidence of clinically significant changes in vital signs: Seated blood pressure
Time frame: Up to 18 days
Incidence of clinically significant changes in vital signs: Resting pulse rate
Time frame: Up to 18 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters
Time frame: Up to 18 days
Incidence of clinically significant changes in clinical laboratory tests: Hematology tests
Time frame: Up to 16 days
Incidence of clinically significant changes in clinical laboratory tests: Coagulation tests
Time frame: Up to 16 days
Incidence of clinically significant changes in clinical laboratory tests: Serum Chemistry tests
Time frame: Up to 16 days
Incidence of clinically significant changes in clinical laboratory tests: Urinalysis tests
Time frame: Up to 16 days
Incidence of clinically significant changes in clinical laboratory tests: Serology tests
Time frame: Up to 16 days
18 secondary outcomes
Maximum observed plasma concentration (Cmax) of BMS-986209
Time frame: Up to 18 days
Time of Maximum observed plasma concentration (Tmax) of BMS-986209
Time frame: Up to 18 days
Terminal plasma half-life (T-Half) of BMS-986209
Time frame: Up to 18 days
Incidence of Adverse Events (AEs) including bleeding
Time frame: Up to 18 days
Incidence of serious AEs (SAEs)
Time frame: Up to 44 days
Incidence of AEs leading to discontinuation
Time frame: Up to 18 days
Incidence of clinically significant changes in vital signs: Body temperature
Time frame: Up to 18 days
Incidence of clinically significant changes in vital signs: Respiratory Rate
Time frame: Up to 18 days
Incidence of clinically significant changes in vital signs: Seated blood pressure
Time frame: Up to 18 days
Incidence of clinically significant changes in vital signs: Resting pulse rate
Time frame: Up to 18 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters
Time frame: Up to 18 days
Incidence of clinically significant changes in clinical laboratory tests: Hematology tests
Time frame: Up to 16 days
Incidence of clinically significant changes in clinical laboratory tests: Coagulation tests
Time frame: Up to 16 days
Incidence of clinically significant changes in clinical laboratory tests: Serum Chemistry tests
Time frame: Up to 16 days
Incidence of clinically significant changes in clinical laboratory tests: Urinalysis tests
Time frame: Up to 16 days
Incidence of clinically significant changes in clinical laboratory tests: Serology tests
Time frame: Up to 16 days
Percent change from baseline in plasma activated partial thromboplastin time (aPTT) levels
Time frame: Up to 16 days
Percent change from baseline in factor XI (FXI) clotting activity
Time frame: Up to 16 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 4 Jan 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Investigator Inquiry FormLink 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-986209, Itraconazole and Diltiazem in people with Health 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 3 inclusion and 9 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 Jan 2022. 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?
Incidence of Adverse Events (AEs) including bleeding (time frame: Up to 18 days). The study lists 13 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 Jan 2022.