Arthroplasty, Replacement, KneePhase 1NCT02914353
Study to Evaluate Safety, PK and PD of Single and Multiple Ascending Doses of EP-7041 in Healthy Subjects
A Phase 1 study testing EP=7041 in people with Arthroplasty, Replacement, Knee, run by eXIthera Pharmaceuticals at 1 site in Australia.
Trial summary
This First-In-Human study will evaluate the safety and tolerability, pharmacokinetic profile, and pharmacodynamic effects of EP-7041, a novel Factor XIa inhibitor, following IV administration of single ascending doses in healthy normal volunteers, and following continuous IV infusions of multiple ascending doses in… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- EP=7041
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteAustralia
- Study dates
- Jul 2016to May 2017
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female, non-smoker (no use of tobacco products within 3 months prior to screening), ≥18 and ≤60 years of age, with Body Mass Index (BMI) > 18.5 and < 32.0 kg/m2 and a weight of at least 60 kg but not greater than 100 kg.
- Healthy as defined by:
- No history of abnormal bleeding episodes, e.g. nosebleeds, or abnormally heavy periods, or extensive bleeding after injury, surgery or dental work.
- A normal short physical examination and normal vital signs (heart rate (HR), blood pressure (BP) and tympanic body temperature).
- Normal laboratory tests (hematology, biochemistry, urinalysis, coagulation tests (aPTT and PT).
- the absence of clinically significant illness and surgery within 4 weeks prior to dosing.
- the absence of clinically significant history of neurological, endocrinal, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
Who cannot join
- Any clinically significant abnormality or abnormal laboratory test results found during medical screening which, at the investigator's discretion, warrants exclusion or positive test for hepatitis B, hepatitis C, or HIV.
- Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to drug administration.
- Positive pregnancy test at screening or check-in (Day -1).
- Clinically significant ECG abnormalities or vital sign abnormalities (systolic blood pressure lower than 90 or over 160 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 40 or over 100 bpm) at screening or check-in (Day -1).
- Participation in a clinical trial involving the administration of an investigational or marketed drug within 30 days (90 days for biologics), or five (5) half-lives, whichever is longer, prior to the first dosing or concomitant participation in an investigational study involving no drug administration.
- Hemoglobin or hematocrit clinically significantly less than lower limits of normal at screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate The Safety Tolerability, Pharmacokinetics, and Pharmacodynamcs of Single and Multiple Ascending Doses of EP-7041 in Hea;Thy Subjects
This First-In-Human study will evaluate the safety and tolerability, pharmacokinetic profile, and pharmacodynamic effects of EP-7041, a novel Factor XIa inhibitor, following IV administration of single ascending doses in healthy normal volunteers, and following continuous IV infusions of multiple ascending doses in healthy normal volunteers.
Read the detailed description
This will be a single-center, Phase 1a/1b, placebo-controlled, randomized, double-blind, integrated sequential ascending dose / multiple ascending dose study.
The study will be divided into two parts: the single ascending dose evaluation in healthy normal volunteers will constitute Part A and the multiple ascending doses evaluation in healthy normal volunteers will constitute Part B. The two study parts will be performed sequentially with partial overlapping.
Part A will include up to 6 cohorts (1 cohort per dose level; 4 planned cohorts and 2 optional adaptive cohorts). Each cohort will include 8 subjects - 6 on active drug and 2 on placebo - resulting in a maximum number of 48 subjects in the study - 32 planned and 16 optional. Subjects in each cohort will receive a single IV slow bolus (50 mL over 5 minutes) administration of study medication or placebo. The dose of EP-7041 will be sequentially escalated cohort by cohort in Part A . A staggered dosing schedule will be used for each cohort of Part A: 2 sentinel subjects (1 active and 1 placebo) will be dosed first and the remaining 6 subjects will be dosed the next day (5 active and 1 placebo).
Part B will include up to 4 cohorts (1 cohort per dose level; 3 planned cohorts and 1 optional adaptive cohort). As in Part A, each cohort of Part B will include 6 subjects on active drug and 2 on placebo, for a total of 8 subjects per cohort. Part B will therefore involve, at maximum, 32 subjects, with 24 planned subjects an 8 optional subjects. Subjects in each cohort of Part B will receive a total of 5 sequential 24-hour IV infusions of EP-7041 or matching placebo.
Evaluation of safety and tolerability to EP-7041 will include adverse events (i.e., seriousness, severity, relationship to EP-7041), vital signs, ECG, clinical laboratory parameters, physical examination, local response to each injection, and body weight.
Pharmacokinetic analyses will be performed with measurements of EP-7041 plasma concentrations, following single and multiple IV doses.
Pharmacodynamic effects of EP-7041 will be evaluated through the measurement of aPTT and PT in all subjects at multiple times throughout the course of both studies.
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- EP=7041, Placebo
- Keywords
- Factor X!a, anticoagulant, thromboembolism, venous thromboembolism, embolism and thrombosis, enzyme inhibitors, hematologic agent
- Medical subject headings
- Thromboembolism, Venous Thromboembolism, Embolism and Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EP=7041Drug
Factor X!a Inhibitor
PlaceboDrug
Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| Experimental - EP-7041 | Experimental | Single Ascending Dose: Single IV dose for each cohort; dose range 0.01 mg/kg to 1.0 mg/kg
Multiple Ascending Dose: 0.01 mg/kg/h - 5 x 24 h continuous infusion up to 0.6 mg/kg/h - 5 x 24 h continuous infusion Receives: Drug: EP=7041 |
| Placebo - Sterile Saline | Placebo comparator | Single Ascending Dose: Single IV dose for each cohort;
Multiple Ascending Dose: 5 x 24 h continuous infusion for each cohort Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 following a single IV bolus of EP-7041
Assessment of safety and tolerability to EP-7041, administered as a single IV bolus, will be based on adverse events. Each AE will be graded with respect to its relationship to treatment using five categories: not related, unlikely, possible, probable, and highly probable. Each AE will also be graded on a three-point severity scale: mild, moderate, and severe. Adverse events will be coded by body system and preferred term using the MedDRA (Medical Dictionary for Regulatory Activities) dictionary. Assessments as to the effect of EP-7041 on vital signs, 12-lead ECG, telemetry, clinical laboratory parameters, physical examination, and local response to each injection, and body weight will also be made.
The number and percentage of subjects experiencing adverse events will be tabulated for each treatment group by body system and preferred term. The number and percentage of subjects experiencing AEs will also be tabulated by relationship to drug treatment and by severity. If an AE is
Measured: Adverse events will be collected and documented during the course of the study. For a period of 30 days following the last study drug administration, adverse events will also be documented if reported.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 following a continuous IV infusion of EP-7041 administered over 5 days
Assessment of safety and tolerability to EP-7041, administered as a continuous IV infusion over 5 days, will be based on adverse events. Each AE will be graded with respect to its relationship to treatment using five categories: not related, unlikely, possible, probable, and highly probable. Each AE will also be graded on a 3-point severity scale: mild, moderate, and severe. Adverse events will be coded by body system and preferred term using the Medical Dictionary for Regulatory Activities dictionary. Assessments as to the effect of EP-7041 on vital signs, 12-lead ECG, telemetry, clinical laboratory parameters, physical examination, and local response to each injection, and body weight will also be made. The number and percentage of subjects experiencing adverse events will be tabulated for each treatment group by body system and preferred term.
The number and percentage of subjects experiencing AEs will also be tabulated by relationship to drug treatment and by severity.
Measured: Adverse events will be collected and documented during the course of the study. For a period of 30 days following the last study drug administration, adverse events will also be documented if reported.
Secondary outcomes (17)
Measurement of Maximum Plasma Concentration Achieved Following a Single IV Bolus of EP-7041
Maximum Plasma Concentration (Cmax)
Measured: 24 hours
Measurement of Time of Maximum Plasma Concentration Following a Single IV Bolus of EP-7041
Time of Maximum Plasma Concentration (Tmax)
Measured: 24 hours
Measurement of Plasma Half-Life Following a Single IV Bolus of EP-7041
Plasma Half-Life (T½)
Measured: 24 hours
Measurement of ClearanceFollowing a Single IV Bolus of EP-7041
Clearance (CL)
Measured: 24 hours
Measurement of the Area Under the Plasma Concentration versus Time Curve Following a Single IV Bolus of EP-7041
Area Under the Curve (AUC)
Measured: 24 hours
Measurement of the Elimination Rate Constant Following a Single IV Bolus of EP-7041
Elimination Rate Constant (Kel)
Measured: 24 hours
Measurement of the Apparent Volume of Distribution Following a Single IV Bolus of EP-7041
Apparent Volume of Distribution (Vd)
Measured: 24 hours
Measurement of the Steady-State Concentration with a the Initiation of Continuous IV 5-day Infusion of EP-7041
Concentration at Steady State (Css)
Measured: 6 days
Measurement of the Time to Reach a Steady-State Concentration Following a the Initiation of Continuous IV 5-day Infusion of EP-7041
Time to Reach Concentration at Steady State (Tss)
Measured: 6 days
Measurement of the Clearance During the Course of a Continuous IV 5-day Infusion of EP-7041
Clearance (CL)
Measured: 6 days
Measurement of the Plasma Half-Life Following the Discontinuation of Continuous IV 5-day Infusion of EP-7041
Plasma Half-Life (T½)
Measured: 6 day
Measurement of Clotting Biomarker Activated Partial Thromboplastin Time Following a Single IV Bolus of EP-7041
Activated Partial Thromboplastin Time (aPTT)
Measured: 1 day
Measurement of Clotting Biomarker Activated Partial Thromboplastin Time During the Course of a Continuous IV 5-day Infusion of EP-7041
Activated Partial Thromboplastin Time (aPTT)
Measured: 6 days
Measurement of Clotting Biomarker Prothrombin Following a Single IV Bolus of EP-7041
Prothrombin Time (PT)
Measured: 1 day
Measurement of Clotting Biomarker Prothrombin During the Course of a Continuous IV 5-day Infusion of EP-7041
Prothrombin Time (PT)
Measured: 6 day
Measurement of Clotting Biomarker International Normalized Ratio Following a Single IV Bolus of EP-7041
International Normalized Ratio (INR)
Measured: 1 day
Measurement of Clotting Biomarker International Normalized Ratio During the Course of a Continuous IV 5-day Infusion of EP-7041
International Normalized Ratio (INR)
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study startJul 2016
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, KneeStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- eXIthera Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IDT CMAX Clinical Trials, Syneos Health, CPR Pharma Services Pty Ltd, Australia
- Responsible party
- Sponsor
- Investigators
- Sepehr Shakib, MD, Principal investigator, IDT CMAX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02914353
- Sponsor's protocol ID
- EXI-111
- Status last verified
- May 2017
- First submitted
- 19 Sep 2016
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate The Safety Tolerability, Pharmacokinetics, and Pharmacodynamcs of Single and Multiple Ascending Doses of EP-7041 in Hea;Thy Subjects
- ClinicalTrials.gov ID
- NCT02914353
- Acronym / sponsor ID
- EXI-111
- Conditions
- Arthroplasty, Replacement, Knee
- Keywords
- Factor X!a, anticoagulant, thromboembolism, venous thromboembolism, embolism and thrombosis, enzyme inhibitors, hematologic agent
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- eXIthera PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- IDT CMAX Clinical Trials, Syneos Health, CPR Pharma Services Pty Ltd, Australia
- Study start
- Jul 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 26 Sep 2016 (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.
This First-In-Human study will evaluate the safety and tolerability, pharmacokinetic profile, and pharmacodynamic effects of EP-7041, a novel Factor XIa inhibitor, following IV administration of single ascending doses in healthy normal volunteers, and following continuous IV infusions of multiple ascending doses in healthy normal volunteers.
Detailed description
This will be a single-center, Phase 1a/1b, placebo-controlled, randomized, double-blind, integrated sequential ascending dose / multiple ascending dose study.
The study will be divided into two parts: the single ascending dose evaluation in healthy normal volunteers will constitute Part A and the multiple ascending doses evaluation in healthy normal volunteers will constitute Part B. The two study parts will be performed sequentially with partial overlapping.
Part A will include up to 6 cohorts (1 cohort per dose level; 4 planned cohorts and 2 optional adaptive cohorts). Each cohort will include 8 subjects - 6 on active drug and 2 on placebo - resulting in a maximum number of 48 subjects in the study - 32 planned and 16 optional. Subjects in each cohort will receive a single IV slow bolus (50 mL over 5 minutes) administration of study medication or placebo. The dose of EP-7041 will be sequentially escalated cohort by cohort in Part A . A staggered dosing schedule will be used for each cohort of Part A: 2 sentinel subjects (1 active and 1 placebo) will be dosed first and the remaining 6 subjects will be dosed the next day (5 active and 1 placebo).
Part B will include up to 4 cohorts (1 cohort per dose level; 3 planned cohorts and 1 optional adaptive cohort). As in Part A, each cohort of Part B will include 6 subjects on active drug and 2 on placebo, for a total of 8 subjects per cohort. Part B will therefore involve, at maximum, 32 subjects, with 24 planned subjects an 8 optional subjects. Subjects in each cohort of Part B will receive a total of 5 sequential 24-hour IV infusions of EP-7041 or matching placebo.
Evaluation of safety and tolerability to EP-7041 will include adverse events (i.e., seriousness, severity, relationship to EP-7041), vital signs, ECG, clinical laboratory parameters, physical examination, local response to each injection, and body weight.
Pharmacokinetic analyses will be performed with measurements of EP-7041 plasma concentrations, following single and multiple IV doses.
Pharmacodynamic effects of EP-7041 will be evaluated through the measurement of aPTT and PT in all subjects at multiple times throughout the course of both studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental - EP-7041 | Experimental | Drug: EP=7041Single Ascending Dose: Single IV dose for each cohort; dose range 0.01 mg/kg to 1.0 mg/kg Multiple Ascending Dose: 0.01 mg/kg/h - 5 x 24 h continuous infusion up to 0.6 mg/kg/h - 5 x 24 h continuous infusion |
| Placebo - Sterile Saline | Placebo comparator | Drug: PlaceboSingle Ascending Dose: Single IV dose for each cohort; Multiple Ascending Dose: 5 x 24 h continuous infusion for each cohort |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female, non-smoker (no use of tobacco products within 3 months prior to screening), ≥18 and ≤60 years of age, with Body Mass Index (BMI) > 18.5 and < 32.0 kg/m2 and a weight of at least 60 kg but not greater than 100 kg.
- Healthy as defined by:
Key exclusion criteria (6 listed)
- Any clinically significant abnormality or abnormal laboratory test results found during medical screening which, at the investigator's discretion, warrants exclusion or positive test for hepatitis B, hepatitis C, or HIV.
- Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to drug administration.
- Positive pregnancy test at screening or check-in (Day -1).
- Clinically significant ECG abnormalities or vital sign abnormalities (systolic blood pressure lower than 90 or over 160 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 40 or over 100 bpm) at screening or check-in (Day -1).
- Participation in a clinical trial involving the administration of an investigational or marketed drug within 30 days (90 days for biologics), or five (5) half-lives, whichever is longer, prior to the first dosing or concomitant participation in an investigational study involving no drug administration.
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 |
|---|---|---|
| EP=7041Factor X!a Inhibitor | Drug | Experimental - EP-7041 |
| PlaceboNormal Saline | Drug | Placebo - Sterile Saline |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 following a single IV bolus of EP-7041
Time frame: Adverse events will be collected and documented during the course of the study. For a period of 30 days following the last study drug administration, adverse events will also be documented if reported.
Assessment of safety and tolerability to EP-7041, administered as a single IV bolus, will be based on adverse events. Each AE will be graded with respect to its relationship to treatment using five categories: not related, unlikely, possible, probable, and highly probable. Each AE will also be graded on a three-point severity scale: mild, moderate, and severe. Adverse events will be coded by body system and preferred term using the MedDRA (Medical Dictionary for Regulatory Activities) dictionary. Assessments as to the effect of EP-7041 on vital signs, 12-lead ECG, telemetry, clinical laboratory parameters, physical examination, and local response to each injection, and body weight will also be made. The number and percentage of subjects experiencing adverse events will be tabulated for each treatment group by body system and preferred term. The number and percentage of subjects experiencing AEs will also be tabulated by relationship to drug treatment and by severity. If an AE is
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 following a continuous IV infusion of EP-7041 administered over 5 days
Time frame: Adverse events will be collected and documented during the course of the study. For a period of 30 days following the last study drug administration, adverse events will also be documented if reported.
Assessment of safety and tolerability to EP-7041, administered as a continuous IV infusion over 5 days, will be based on adverse events. Each AE will be graded with respect to its relationship to treatment using five categories: not related, unlikely, possible, probable, and highly probable. Each AE will also be graded on a 3-point severity scale: mild, moderate, and severe. Adverse events will be coded by body system and preferred term using the Medical Dictionary for Regulatory Activities dictionary. Assessments as to the effect of EP-7041 on vital signs, 12-lead ECG, telemetry, clinical laboratory parameters, physical examination, and local response to each injection, and body weight will also be made. The number and percentage of subjects experiencing adverse events will be tabulated for each treatment group by body system and preferred term. The number and percentage of subjects experiencing AEs will also be tabulated by relationship to drug treatment and by severity.
17 secondary outcomes
Measurement of Maximum Plasma Concentration Achieved Following a Single IV Bolus of EP-7041
Time frame: 24 hours
Measurement of Time of Maximum Plasma Concentration Following a Single IV Bolus of EP-7041
Time frame: 24 hours
Measurement of Plasma Half-Life Following a Single IV Bolus of EP-7041
Time frame: 24 hours
Measurement of ClearanceFollowing a Single IV Bolus of EP-7041
Time frame: 24 hours
Measurement of the Area Under the Plasma Concentration versus Time Curve Following a Single IV Bolus of EP-7041
Time frame: 24 hours
Measurement of the Elimination Rate Constant Following a Single IV Bolus of EP-7041
Time frame: 24 hours
Measurement of the Apparent Volume of Distribution Following a Single IV Bolus of EP-7041
Time frame: 24 hours
Measurement of the Steady-State Concentration with a the Initiation of Continuous IV 5-day Infusion of EP-7041
Time frame: 6 days
Measurement of the Time to Reach a Steady-State Concentration Following a the Initiation of Continuous IV 5-day Infusion of EP-7041
Time frame: 6 days
Measurement of the Clearance During the Course of a Continuous IV 5-day Infusion of EP-7041
Time frame: 6 days
Measurement of the Plasma Half-Life Following the Discontinuation of Continuous IV 5-day Infusion of EP-7041
Time frame: 6 day
Measurement of Clotting Biomarker Activated Partial Thromboplastin Time Following a Single IV Bolus of EP-7041
Time frame: 1 day
Measurement of Clotting Biomarker Activated Partial Thromboplastin Time During the Course of a Continuous IV 5-day Infusion of EP-7041
Time frame: 6 days
Measurement of Clotting Biomarker Prothrombin Following a Single IV Bolus of EP-7041
Time frame: 1 day
Measurement of Clotting Biomarker Prothrombin During the Course of a Continuous IV 5-day Infusion of EP-7041
Time frame: 6 day
Measurement of Clotting Biomarker International Normalized Ratio Following a Single IV Bolus of EP-7041
Time frame: 1 day
Measurement of Clotting Biomarker International Normalized Ratio During the Course of a Continuous IV 5-day Infusion of EP-7041
Time frame: 6 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 31 May 2017.
- Individual participant dataSharing planned: No
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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.
Sepehr Shakib, MD principal investigator
IDT CMAX
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 EP=7041 in people with Arthroplasty, Replacement, Knee, run by eXIthera Pharmaceuticals at 1 site in Australia.
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 7 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 31 May 2017. 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 Australia. 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?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 following a single IV bolus of EP-7041 (time frame: Adverse events will be collected and documented during the course of the study. For a period of 30 days following the last study drug administration, adverse events will also be documented if reported.). 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?
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 May 2017.