Healthy Adult VolunteersPhase 1NCT02208882
Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BMS-986120 in Healthy Subjects and the Effects of Co-Administration of Midazolam and BMS-986120
A Phase 1 study testing BMS-986120 and Midazolam in people with Healthy Adult Volunteers, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety, tolerability and effect on Midazolam pharmacokinetics of multiple oral doses of BMS-986120 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Volunteers
- What is being tested?
- BMS-986120 and Midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Feb 2015
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and female subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI=Weight (kg)/[Height(m)]2
- Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) and men, ages 18 to 75, inclusive
Who cannot join
- Concurrent, or use within 2-weeks of study drug administration, of marketed or investigational, non-steroidal anti-inflammatory compounds (NSAIDS), aspirin or other antiplatelet agents, oral or parenteral anticoagulants
- Subjects at screening or prior to first dose with the following abnormal laboratory values upon repeat testing are excluded:
- i) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >upper limit of normal (ULN)
- ii) Total bilirubin >ULN, thyroid-stimulating hormone (TSH) >1.5 x ULN with T4 within normal limits (Subjects with mild unconjugated hyperbilirubinemia due to Gilbert's syndrome are excluded)
- iii) CK >3 x ULN (unless exercise related and CK-MB within normal limits)
- iv) Activated partial thromboplastin (aPTT) or Prothrombin Time (PT)/International Normalized Ratio (INR) >ULN
Show all 13Show fewer
- v) Blood urea nitrogen (BUN) or creatinine (Cr) >ULN
- Hemoglobin or hematocrit or platelet count <lower limit of normal (LLN)
- Bleeding time exceeding 8 minutes at pre-dose on Day -1
- Subjects with micro- or macro-hematuria and/or fecal occult blood detected during screening, baseline or documented during other recent medical assessment, unless deemed not clinically significant by the Investigator and Medical Monitor
- Any significant acute or chronic medical illness
- Current or recent (within 3 months of study drug administration) gastrointestinal disease
- Any major surgery within 12 weeks of study drug administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Oral Doses of BMS-986120 in Healthy Subjects and the Effect of BMS-986120 on the Pharmacokinetics of Midazolam in Healthy Subjects
The purpose of this study is to assess the safety, tolerability and effect on Midazolam pharmacokinetics of multiple oral doses of BMS-986120 in healthy subjects.
- Conditions
- Healthy Adult Volunteers
- Being tested
- BMS-986120, Placebo, Midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986120Drug
PlaceboDrug
MidazolamDrug
| Study group | Role | What they receive |
|---|---|---|
| Panel 1: BMS-986120 or Placebo | Experimental | BMS-986120 or Placebo multiple dose by mouth as specified Receives: Drug: BMS-986120; Drug: Placebo |
| Panel 2: BMS-986120 or Placebo | Experimental | BMS-986120 or Placebo multiple dose by mouth as specified Receives: Drug: BMS-986120; Drug: Placebo |
| Panel 3: BMS-986120 or Placebo + Midazolam | Experimental | BMS-986120 or Placebo (multiple dose) + Midazolam (single dose) by mouth as specified Receives: Drug: BMS-986120; Drug: Placebo; Drug: Midazolam |
| Panel 4: BMS-986120 or Placebo | Experimental | BMS-986120 or Placebo multiple dose by mouth as specified Receives: Drug: BMS-986120; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability measured by number of subjects experience serious adverse events, deaths, adverse events leading to discontinuation, and potential clinically significant changes in electrocardiogram (ECG) parameters
Measured: Up to 168 days
Safety and tolerability measured by percent of subjects experience serious adverse events, deaths, adverse events leading to discontinuation, and potential clinically significant changes in electrocardiogram (ECG) parameters
Measured: Up to 168 days
Secondary outcomes (14)
Maximum observed plasma concentration (Cmax) of BMS-986120, BMT-141464, Midazolam, and 1'hydroxymidazolam
Measured: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
Time of maximum observed plasma concentration (Tmax) of BMS-986120, BMT-141464, Midazolam, and 1'hydroxymidazolam
Measured: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
Area under the concentration-time curve from time zero to 24h [AUC(TAU)] of BMS-986120 and BMT-141464
Measured: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
Concentration at the end of the dosing Interval (Ctau) of BMS-986120 and BMT-141464
Measured: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
Half-life (T-HALF) of BMS-986120 and BMT-141464
Measured: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
Apparent total body clearance (CLT/F) of BMS-986120, Midazolam, and 1'hydroxymidazolam
Measured: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
AUC accumulation index (AI_AUC) of BMS-986120 and BMT-141464
Measured: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
Effective elimination half-life that explains the degree of AUC accumulation observed (T-HALFeff_AUC) of BMS-986120
Measured: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
Ratio of metabolite AUC(TAU) to parent AUC(TAU), corrected for molecular weight [MR_AUC(TAU)] of BMT-141464
Measured: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
Ratio of metabolite Cmax to parent Cmax, corrected for molecular weight (MR_Cmax) of BMT-141464
Measured: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of Midazolam and 1'hydroxymidazolam
Measured: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of Midazolam and 1'hydroxymidazolam
Measured: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
Ratio of metabolite AUC(INF) to parent AUC(INF), corrected for molecular weight [MR_AUC(INF)] of 1'hydroxymidazolam
Measured: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
Change from baseline in protease-activated receptor-4 - agonist peptide (PAR4-AP) induced platelet aggregation of BMS-986120
Measured: Part A (Days 1-3) & Part B/C (Days 1-19)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionFeb 2015
- Study completionFeb 2015
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 Healthy Adult 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- 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
- NCT02208882
- Sponsor's protocol ID
- CV004-006
- Status last verified
- Jul 2015
- First submitted
- 4 Aug 2014
- Last updated
- 7 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Merali S, Wang Z, Frost C, Callejo M, Hedrick M, Hui L, Meadows Shropshire S, Xu K, Bouvier M, DeSouza MM, Yang J. New oral protease-activated receptor 4 antagonist BMS-986120: tolerability, pharmacokinetics, pharmacodynamics, and gene variant effects in humans. Platelets. 2022 Oct 3;33(7):969-978. doi: 10.1080/09537104.2022.2088719. Epub 2022 Jun 26.
PubMed 35758258
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Oral Doses of BMS-986120 in Healthy Subjects and the Effect of BMS-986120 on the Pharmacokinetics of Midazolam in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02208882
- Acronym / sponsor ID
- CV004-006
- Conditions
- Healthy Adult Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 5 Aug 2014 (estimated)
- 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 safety, tolerability and effect on Midazolam pharmacokinetics of multiple oral doses of BMS-986120 in healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Panel 1: BMS-986120 or Placebo | Experimental | Drug: BMS-986120, Drug: PlaceboBMS-986120 or Placebo multiple dose by mouth as specified |
| Panel 2: BMS-986120 or Placebo | Experimental | Drug: BMS-986120, Drug: PlaceboBMS-986120 or Placebo multiple dose by mouth as specified |
| Panel 3: BMS-986120 or Placebo + Midazolam | Experimental | Drug: BMS-986120, Drug: Placebo, Drug: MidazolamBMS-986120 or Placebo (multiple dose) + Midazolam (single dose) by mouth as specified |
| Panel 4: BMS-986120 or Placebo | Experimental | Drug: BMS-986120, Drug: PlaceboBMS-986120 or Placebo multiple dose by mouth as specified |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy male and female subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI=Weight (kg)/[Height(m)]2
- Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) and men, ages 18 to 75, inclusive
Key exclusion criteria (13 listed)
- Concurrent, or use within 2-weeks of study drug administration, of marketed or investigational, non-steroidal anti-inflammatory compounds (NSAIDS), aspirin or other antiplatelet agents, oral or parenteral anticoagulants
- Subjects at screening or prior to first dose with the following abnormal laboratory values upon repeat testing are excluded:
- Hemoglobin or hematocrit or platelet count <lower limit of normal (LLN)
- Bleeding time exceeding 8 minutes at pre-dose on Day -1
- Subjects with micro- or macro-hematuria and/or fecal occult blood detected during screening, baseline or documented during other recent medical assessment, unless deemed not clinically significant by the Investigator and Medical Monitor
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-986120 | Drug | Panel 1: BMS-986120 or Placebo, Panel 2: BMS-986120 or Placebo, Panel 3: BMS-986120 or Placebo + Midazolam, Panel 4: BMS-986120 or Placebo |
| Placebo | Drug | Panel 1: BMS-986120 or Placebo, Panel 2: BMS-986120 or Placebo, Panel 3: BMS-986120 or Placebo + Midazolam, Panel 4: BMS-986120 or Placebo |
| Midazolam | Drug | Panel 3: BMS-986120 or Placebo + Midazolam |
Primary outcome
Safety and tolerability measured by number of subjects experience serious adverse events, deaths, adverse events leading to discontinuation, and potential clinically significant changes in electrocardiogram (ECG) parameters
Time frame: Up to 168 days
Safety and tolerability measured by percent of subjects experience serious adverse events, deaths, adverse events leading to discontinuation, and potential clinically significant changes in electrocardiogram (ECG) parameters
Time frame: Up to 168 days
14 secondary outcomes
Maximum observed plasma concentration (Cmax) of BMS-986120, BMT-141464, Midazolam, and 1'hydroxymidazolam
Time frame: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
Time of maximum observed plasma concentration (Tmax) of BMS-986120, BMT-141464, Midazolam, and 1'hydroxymidazolam
Time frame: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
Area under the concentration-time curve from time zero to 24h [AUC(TAU)] of BMS-986120 and BMT-141464
Time frame: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
Concentration at the end of the dosing Interval (Ctau) of BMS-986120 and BMT-141464
Time frame: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
Half-life (T-HALF) of BMS-986120 and BMT-141464
Time frame: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
Apparent total body clearance (CLT/F) of BMS-986120, Midazolam, and 1'hydroxymidazolam
Time frame: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
AUC accumulation index (AI_AUC) of BMS-986120 and BMT-141464
Time frame: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
Effective elimination half-life that explains the degree of AUC accumulation observed (T-HALFeff_AUC) of BMS-986120
Time frame: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
Ratio of metabolite AUC(TAU) to parent AUC(TAU), corrected for molecular weight [MR_AUC(TAU)] of BMT-141464
Time frame: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
Ratio of metabolite Cmax to parent Cmax, corrected for molecular weight (MR_Cmax) of BMT-141464
Time frame: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of Midazolam and 1'hydroxymidazolam
Time frame: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of Midazolam and 1'hydroxymidazolam
Time frame: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
Ratio of metabolite AUC(INF) to parent AUC(INF), corrected for molecular weight [MR_AUC(INF)] of 1'hydroxymidazolam
Time frame: Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
Change from baseline in protease-activated receptor-4 - agonist peptide (PAR4-AP) induced platelet aggregation of BMS-986120
Time frame: Part A (Days 1-3) & Part B/C (Days 1-19)
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 7 Jul 2015.
- Derived from this study: PubMed 35758258Merali S, Wang Z, Frost C, Callejo M, Hedrick M, Hui L, Meadows Shropshire S, Xu K, Bouvier M, DeSouza MM, Yang J. New oral protease-activated receptor 4 antagonist BMS-986120: tolerability, pharmacokinetics, pharmacodynamics, and gene variant effects in humans. Platelets. 2022 Oct 3;33(7):969-978. doi: 10.1080/09537104.2022.2088719. Epub 2022 Jun 26.
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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-986120 and Midazolam in people with Healthy Adult 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 3 inclusion and 13 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 7 Jul 2015. 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?
Safety and tolerability measured by number of subjects experience serious adverse events, deaths, adverse events leading to discontinuation, and potential clinically significant changes in electrocardiogram (ECG) parameters (time frame: Up to 168 days). 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?
On the ClinicalTrials.gov record for NCT02208882, 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 7 Jul 2015.