ThrombosisPhase 1NCT02341638
Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986141 in Healthy Subjects
A Phase 1 study testing BMS-986141, Aspirin and Itraconazole in people with Thrombosis, run by Bristol-Myers Squibb at 2 sites in United States.
Trial summary
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a single and multiple oral doses of BMS-986141 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
- Thrombosis
- What is being tested?
- BMS-986141, Aspirin and Itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2014to Sep 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, drugs as specified in protocol
- Other protocol-defined exclusion criteria could apply
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ppd Development, Lp
Austin, Texas, 78744
West Coast Clinical Trials, Llc
Cypress, California, 90630
About this study
Official title: Randomized, Double-Blinded, Placebo-Controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986141 in Healthy Subjects
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a single and multiple oral doses of BMS-986141 in healthy subjects.
Read the detailed description
Maximum Age:
Part A SAD 65 years
Part B MAD 75 years
Part C MAD Japanese 75 years
- Conditions
- Thrombosis
- Being tested
- BMS-986141, Placebo, Aspirin, Itraconazole
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986141Drug
PlaceboDrug
AspirinDrug
ItraconazoleDrug
| Study group | Role | What they receive |
|---|---|---|
| Part A Panel 1: BMS-986141 or Placebo | Experimental | BMS-986141 or Placebo single dose by mouth as specified Receives: Drug: BMS-986141; Drug: Placebo |
| Part A Panel 2: BMS-986141 or Placebo | Experimental | BMS-986141 or Placebo single dose by mouth as specified Receives: Drug: BMS-986141; Drug: Placebo |
| Part A Panel 3: BMS-986141 or Placebo | Experimental | BMS-986141 or Placebo single dose by mouth as specified Receives: Drug: BMS-986141; Drug: Placebo |
| Part A Panel 4: BMS-986141 or Placebo | Experimental | BMS-986141 or Placebo single dose by mouth as specified Receives: Drug: BMS-986141; Drug: Placebo |
| Part A Panel 5: BMS-986141 or Placebo | Experimental | BMS-986141 or Placebo single dose by mouth as specified Receives: Drug: BMS-986141; Drug: Placebo |
| Part A Panel 6: BMS-986141 or Placebo | Experimental | BMS-986141 or Placebo single dose by mouth as specified Receives: Drug: BMS-986141; Drug: Placebo |
| Part A Panel 7: BMS-986141 | Experimental | Single dose by mouth as specified Receives: Drug: BMS-986141 |
| Part A Panel 8: BMS-986141 | Experimental | Single dose by mouth as specified Receives: Drug: BMS-986141 |
| Part B Panel 1: BMS-986141 or Placebo | Experimental | BMS-986141 or Placebo by mouth as specified Receives: Drug: BMS-986141; Drug: Placebo |
| Part B Panel 2: BMS-986141 or Placebo | Experimental | BMS-986141 or Placebo by mouth as specified Receives: Drug: BMS-986141; Drug: Placebo |
| Part B Panel 3: BMS-986141 or Placebo | Experimental | BMS-986141 or Placebo by mouth as specified Receives: Drug: BMS-986141; Drug: Placebo |
| Part C Panel 1: BMS-986141 or Placebo | Experimental | BMS-986141 or Placebo by mouth as specified Receives: Drug: BMS-986141; Drug: Placebo |
| Part C Panel 2: BMS-986141 or Placebo | Experimental | BMS-986141 or Placebo by mouth as specified Receives: Drug: BMS-986141; Drug: Placebo |
| Part C Panel 3: BMS-986141 or Placebo | Experimental | BMS-986141 or Placebo by mouth as specified Receives: Drug: BMS-986141; Drug: Placebo |
| Part D Panel 1: BMS-986141 and Aspirin | Experimental | BMS-986141 and Aspirin by mouth as specified Receives: Drug: BMS-986141; Drug: Aspirin |
| Part D Panel 1: Placebo matching BMS-986141 and Aspirin | Placebo comparator | BMS-986141 placebo and Aspirin by mouth as specified Receives: Drug: Placebo; Drug: Aspirin |
| Part E Panel 1: BMS-986141 and Itraconazole | Experimental | BMS-986141 and Itraconazole by mouth as specified Receives: Drug: BMS-986141; Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
Serious adverse event (SAE)
Adverse event (AE)
Electrocardiogram (ECG)
Measured: Up to 30 days post discontinuation of dosing or last participation in the study
Tolerability measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
Measured: Up to 30 days post discontinuation of dosing or last participation in the study
Safety measured by percent of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
Measured: Up to 30 days post discontinuation of dosing or last participation in the study
Tolerability measured by percent of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
Measured: Up to 30 days post discontinuation of dosing or last participation in the study
Secondary outcomes (17)
Maximum observed plasma concentration (Cmax) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551
Measured: Up to Day 14
Time of maximum observed plasma concentration (Tmax) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551
Measured: Up to Day 14
Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986141, BMT-162853, BMT-162856, and BMT-181551
Measured: Up to Day 14
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986141, BMT-162853, BMT-162856, and BMT-181551
Measured: Up to Day 14
Concentration at 24 hours (C24) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551
Measured: Up to Day 14
Half-life (T-HALF) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551
Measured: Up to Day 14
Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-986141, BMT-162853, BMT-162856, and BMT-181551
Measured: Up to Day 14
AUC accumulation index (AI_AUC) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551; ratio of AUC(TAU) at steady-state to AUC(TAU) after the first dose
Measured: Up to Day 14
Effective elimination half-life that explains the degree of AUC accumulation observed (T-HALFeff_AUC) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551
Measured: Up to Day 14
MR_Cmax of BMT-162853, BMT-162856, and BMT-181551
Ratio of metabolite Cmax to parent Cmax, corrected for molecular weight (MR_Cmax)
Measured: Up to Day 14
MR_AUC(INF) of BMT-162853, BMT-162856, and BMT-181551
Ratio of metabolite AUC(INF) to parent AUC(INF), corrected for molecular weight [MR_AUC(INF)]
Measured: Up to Day 14
MR_AUC(0-T) of BMT-162853, BMT-162856, and BMT-181551
Ratio of metabolite AUC(0-T) to parent AUC(0-T), corrected for molecular weight [MR_AUC(0-T)]
Measured: Up to Day 14
MR_AUC(TAU) of BMT-162853, BMT-162856, and BMT-181551
Ratio of metabolite AUC(TAU) to parent AUC(TAU), corrected for molecular weight [MR_AUC(TAU)]
Measured: Up to Day 14
Safety of multiple doses of BMS-986141 and aspirin in healthy subjects
Safety measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations.
Measured: Up to 30 days post discontinuation of dosing or last participation in the study
Tolerability of multiple doses of BMS-986141 and aspirin in healthy subjects
Tolerability measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
Measured: Up to 30 days post discontinuation of dosing or last participation in the study
Safety of BMS-986141 and itraconazole in healthy subjects
Safety measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
Measured: Up to 30 days post discontinuation of dosing or last participation in the study
Tolerability of BMS-986141 and itraconazole in healthy subjects
Tolerability measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
Measured: Up to 30 days post discontinuation of dosing or last participation in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startSep 2014
- Primary completionSep 2015
- Study completionSep 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 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 148 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
- NCT02341638
- Sponsor's protocol ID
- CV006-003
- Status last verified
- Sep 2015
- First submitted
- 14 Jan 2015
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Merali S, Wang Z, Frost C, Meadows-Shropshire S, Hawthorne D, Yang J, Seiffert D. First-in-human study to assess the safety, pharmacokinetics, and pharmacodynamics of BMS-986141, a novel, reversible, small-molecule, PAR4 agonist in non-Japanese and Japanese healthy participants. Platelets. 2023 Dec;34(1):2222846. doi: 10.1080/09537104.2023.2222846.
PubMed 37394920
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blinded, Placebo-Controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986141 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02341638
- Acronym / sponsor ID
- CV006-003
- Conditions
- Thrombosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 19 Jan 2015 (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, pharmacokinetics (PK) and pharmacodynamics (PD) of a single and multiple oral doses of BMS-986141 in healthy subjects.
Detailed description
Maximum Age:
Part A SAD 65 years
Part B MAD 75 years
Part C MAD Japanese 75 years
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 17
| Arm | Type | Receives |
|---|---|---|
| Part A Panel 1: BMS-986141 or Placebo | Experimental | Drug: BMS-986141, Drug: PlaceboBMS-986141 or Placebo single dose by mouth as specified |
| Part A Panel 2: BMS-986141 or Placebo | Experimental | Drug: BMS-986141, Drug: PlaceboBMS-986141 or Placebo single dose by mouth as specified |
| Part A Panel 3: BMS-986141 or Placebo | Experimental | Drug: BMS-986141, Drug: PlaceboBMS-986141 or Placebo single dose by mouth as specified |
| Part A Panel 4: BMS-986141 or Placebo | Experimental | Drug: BMS-986141, Drug: PlaceboBMS-986141 or Placebo single dose by mouth as specified |
| Part A Panel 5: BMS-986141 or Placebo | Experimental | Drug: BMS-986141, Drug: PlaceboBMS-986141 or Placebo single dose by mouth as specified |
| Part A Panel 6: BMS-986141 or Placebo | Experimental | Drug: BMS-986141, Drug: PlaceboBMS-986141 or Placebo single dose by mouth as specified |
| Part A Panel 7: BMS-986141 | Experimental | Drug: BMS-986141Single dose by mouth as specified |
| Part A Panel 8: BMS-986141 | Experimental | Drug: BMS-986141Single dose by mouth as specified |
| Part B Panel 1: BMS-986141 or Placebo | Experimental | Drug: BMS-986141, Drug: PlaceboBMS-986141 or Placebo by mouth as specified |
| Part B Panel 2: BMS-986141 or Placebo | Experimental | Drug: BMS-986141, Drug: PlaceboBMS-986141 or Placebo by mouth as specified |
| Part B Panel 3: BMS-986141 or Placebo | Experimental | Drug: BMS-986141, Drug: PlaceboBMS-986141 or Placebo by mouth as specified |
| Part C Panel 1: BMS-986141 or Placebo | Experimental | Drug: BMS-986141, Drug: PlaceboBMS-986141 or Placebo by mouth as specified |
| Part C Panel 2: BMS-986141 or Placebo | Experimental | Drug: BMS-986141, Drug: PlaceboBMS-986141 or Placebo by mouth as specified |
| Part C Panel 3: BMS-986141 or Placebo | Experimental | Drug: BMS-986141, Drug: PlaceboBMS-986141 or Placebo by mouth as specified |
| Part D Panel 1: BMS-986141 and Aspirin | Experimental | Drug: BMS-986141, Drug: AspirinBMS-986141 and Aspirin by mouth as specified |
| Part D Panel 1: Placebo matching BMS-986141 and Aspirin | Placebo comparator | Drug: Placebo, Drug: AspirinBMS-986141 placebo and Aspirin by mouth as specified |
| Part E Panel 1: BMS-986141 and Itraconazole | Experimental | Drug: BMS-986141, Drug: ItraconazoleBMS-986141 and Itraconazole 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 (2 listed)
- Concurrent or use within 2 weeks of study drug administration, of marketed or investigational, drugs as specified in protocol
- Other protocol-defined 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-986141 | Drug | Part A Panel 1: BMS-986141 or Placebo, Part A Panel 2: BMS-986141 or Placebo, Part A Panel 3: BMS-986141 or Placebo, Part A Panel 4: BMS-986141 or Placebo, Part A Panel 5: BMS-986141 or Placebo, Part A Panel 6: BMS-986141 or Placebo, Part A Panel 7: BMS-986141, Part A Panel 8: BMS-986141, Part B Panel 1: BMS-986141 or Placebo, Part B Panel 2: BMS-986141 or Placebo, Part B Panel 3: BMS-986141 or Placebo, Part C Panel 1: BMS-986141 or Placebo, Part C Panel 2: BMS-986141 or Placebo, Part C Panel 3: BMS-986141 or Placebo, Part D Panel 1: BMS-986141 and Aspirin, Part E Panel 1: BMS-986141 and Itraconazole |
| Placebo | Drug | Part A Panel 1: BMS-986141 or Placebo, Part A Panel 2: BMS-986141 or Placebo, Part A Panel 3: BMS-986141 or Placebo, Part A Panel 4: BMS-986141 or Placebo, Part A Panel 5: BMS-986141 or Placebo, Part A Panel 6: BMS-986141 or Placebo, Part B Panel 1: BMS-986141 or Placebo, Part B Panel 2: BMS-986141 or Placebo, Part B Panel 3: BMS-986141 or Placebo, Part C Panel 1: BMS-986141 or Placebo, Part C Panel 2: BMS-986141 or Placebo, Part C Panel 3: BMS-986141 or Placebo, Part D Panel 1: Placebo matching BMS-986141 and Aspirin |
| Aspirin | Drug | Part D Panel 1: BMS-986141 and Aspirin, Part D Panel 1: Placebo matching BMS-986141 and Aspirin |
| Itraconazole | Drug | Part E Panel 1: BMS-986141 and Itraconazole |
Primary outcome
Safety measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
Time frame: Up to 30 days post discontinuation of dosing or last participation in the study
Serious adverse event (SAE) Adverse event (AE) Electrocardiogram (ECG)
Tolerability measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
Time frame: Up to 30 days post discontinuation of dosing or last participation in the study
Safety measured by percent of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
Time frame: Up to 30 days post discontinuation of dosing or last participation in the study
Tolerability measured by percent of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
Time frame: Up to 30 days post discontinuation of dosing or last participation in the study
17 secondary outcomes
Maximum observed plasma concentration (Cmax) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551
Time frame: Up to Day 14
Time of maximum observed plasma concentration (Tmax) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551
Time frame: Up to Day 14
Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986141, BMT-162853, BMT-162856, and BMT-181551
Time frame: Up to Day 14
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986141, BMT-162853, BMT-162856, and BMT-181551
Time frame: Up to Day 14
Concentration at 24 hours (C24) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551
Time frame: Up to Day 14
Half-life (T-HALF) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551
Time frame: Up to Day 14
Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-986141, BMT-162853, BMT-162856, and BMT-181551
Time frame: Up to Day 14
AUC accumulation index (AI_AUC) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551; ratio of AUC(TAU) at steady-state to AUC(TAU) after the first dose
Time frame: Up to Day 14
Effective elimination half-life that explains the degree of AUC accumulation observed (T-HALFeff_AUC) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551
Time frame: Up to Day 14
MR_Cmax of BMT-162853, BMT-162856, and BMT-181551
Time frame: Up to Day 14
MR_AUC(INF) of BMT-162853, BMT-162856, and BMT-181551
Time frame: Up to Day 14
MR_AUC(0-T) of BMT-162853, BMT-162856, and BMT-181551
Time frame: Up to Day 14
MR_AUC(TAU) of BMT-162853, BMT-162856, and BMT-181551
Time frame: Up to Day 14
Safety of multiple doses of BMS-986141 and aspirin in healthy subjects
Time frame: Up to 30 days post discontinuation of dosing or last participation in the study
Tolerability of multiple doses of BMS-986141 and aspirin in healthy subjects
Time frame: Up to 30 days post discontinuation of dosing or last participation in the study
Safety of BMS-986141 and itraconazole in healthy subjects
Time frame: Up to 30 days post discontinuation of dosing or last participation in the study
Tolerability of BMS-986141 and itraconazole in healthy subjects
Time frame: Up to 30 days post discontinuation of dosing or last participation in the study
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 31 Mar 2017.
- Derived from this study: PubMed 37394920Merali S, Wang Z, Frost C, Meadows-Shropshire S, Hawthorne D, Yang J, Seiffert D. First-in-human study to assess the safety, pharmacokinetics, and pharmacodynamics of BMS-986141, a novel, reversible, small-molecule, PAR4 agonist in non-Japanese and Japanese healthy participants. Platelets. 2023 Dec;34(1):2222846. doi: 10.1080/09537104.2023.2222846.
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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
2 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-986141, Aspirin and Itraconazole in people with Thrombosis, run by Bristol-Myers Squibb at 2 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 3 inclusion and 2 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 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. Some participants in this study may receive a placebo. 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 measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations (time frame: Up to 30 days post discontinuation of dosing or last participation in the study). The study lists 4 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 NCT02341638, 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 31 Mar 2017.