Renal InsufficiencyPhase 1NCT05283746
A Study of Epetraborole Tablets in Subjects With Degrees of Renal Function
A Phase 1 study testing Epetraborole in people with Renal Insufficiency, run by AN2 Therapeutics, Inc at 3 sites in United States.
Trial summary
This is a Phase 1 study to evaluate the pharmacokinetics (PK), safety and tolerability of epetraborole tablets in adult subjects with normal renal function, subjects with various degrees of renal impairment, and subjects with end-stage renal disease (ESRD) receiving intermittent hemodialysis (IHD) therapy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Renal Insufficiency
- What is being tested?
- Epetraborole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Feb 2022to 27 Jun 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All subjects:
- Adult males or females of 18 years of age or older at the time of Screening
- Willing and able to provide written informed consent
- BMI between 18.0 and 40.0 kg/m2 (inclusive) and weight of at least 50.0 kg
- Have suitable venous access for blood sampling
- Light-, non- or ex-smoker (A light smoker is defined as someone using 10.0 nicotine units or less per day for at least 90 days prior to the first study drug administration. An ex smoker is defined as someone who completely stopped using nicotine products for at least 180 days prior to the first study drug administration)
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- Ability and willingness to abstain from alcohol from 48 hours prior to the first study drug administration until discharge from the clinical unit
- Be willing and able to comply with all study assessments and adhere to the protocol schedule, including the entire confinement period and the follow-up visit
- If female of childbearing potential, must agree to and comply with using 1 barrier method (eg, female condom or male partner using a condom) with 1 other highly effective method of birth control (eg, oral contraceptive, implant, injectable, indwelling intrauterine device, vasectomized partner), or sexual abstinence, for the duration of the study (from signing of consent to the follow-up visit) and for 30 days after last study drug administration. Females of childbearing potential must also agree not to donate ova or oocytes (ie, human eggs) during the study, and for 1 menstrual cycle after completion of the study. To be considered of non-childbearing potential, a female must have had a tubal ligation, hysterectomy, bilateral salpingo oophrectomy, or be menopaused (last menstruation >12 months prior to the first study drug administration and follicle stimulating hormone in menopausal range). Provision of written documentation is not required for female sterilization and oral confirmation is adequate.
- Male subjects, if sexually active with a female partner of childbearing potential, must agree to and comply with using 1 barrier method of birth control (eg, male condom) with 1 other highly effective method of birth control in their partner (eg, oral contraceptive; implant, injectable, indwelling intrauterine device), or sexual abstinence, and must not donate sperm, for the duration of the study (from signing of consent to the follow-up visit) and for 90 days after last study drug administration
- Cohort 1:
- Medically and hemodynamically stable without CS abnormalities at the screening visit or Day -1, based on physical examination, vital signs, 12-lead ECG, and laboratory results
- Normal renal function with eGFR ≥ 90 mL/min/1.73m2, calculated using the CKD-EPI equation. A 24-hour urine collection for creatinine clearance test may be conducted prior to Day -1 to confirm the healthy renal function status if, as judged by an Investigator, the result of the eGFR calculated using the CKD-EPI equation at Screening does not reflect the subject's true renal function.
- Cohorts 2 to 4:
- Renal impairment with eGFR ≥ 60 and < 90 mL/min/1.73m2 (Cohort 2), ≥ 30 and < 60 mL/min/1.73m2 (Cohort 3), or < 30 mL/min/1.73m2 (Cohort 4), calculated using the CKD-EPI equation.
- Cohort 5:
- Subjects with ESRD (eGFR < 15 mL/min/1.73m2) receiving IHD at least 3 times per week for at least 3 months at Screening.
- Cohorts 2 to 5:
- Medically and hemodynamically stable without CS acute or chronic illness other than renal impairment that may impact the assessment of PK and safety as assessed by the Investigator, based on physical examination, vital signs, 12-lead ECG, and laboratory results
Who cannot join
- All subjects:
- Female who is lactating or is pregnant according to the pregnancy test at Screening or prior to the first study drug administration
- Any CS medical history or abnormal findings upon physical examination, or clinical laboratory tests, not specifically excluded in other criteria below that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject
- QTcF interval duration > 500 msec obtained as an average from the triplicate ECGs taken at least 1 minute apart after at least 5 minutes in a semi-supine, quiet rest position at Screening or prior to the first study drug administration
- Results of biochemistry tests for alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin greater than 1.5 × the upper limit of normal (ULN) for the reference laboratory, or history of chronic liver disease, cirrhosis, or biliary disease. For subjects with Gilbert's Syndrome, the subject may be included in the study at the discretion of the Investigator if the bilirubin levels are within the range for this condition.
- Recent history (within 6 months) of known or suspected Clostridioides difficile infection
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- History of seizure disorder except childhood history of febrile seizures
- Positive drug/alcohol testing at Screening or prior to the first study drug administration unless the positive drug screen is due to prescription drug use that is approved by the Investigator and the Sponsor's Medical Monitor
- Positive testing for HIV, hepatitis B surface antigen, or hepatitis C virus antibody at Screening
- History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months prior to Screening
- History of hypersensitivity reaction or anaphylaxis to any medication, unless deemed not CS by an Investigator
- Donation of blood or plasma within 30 days prior to the first study drug administration, or loss of whole blood of more than 500 mL within 30 days prior to the first study drug administration
- Receipt of an investigational drug within 30 days or 5 half-lives prior to the first administration of study drug, whichever is longer
- Any other condition or prior therapy, which, in the opinion of an Investigator, would make the volunteer unsuitable for this study, including unable to cooperate fully with the requirements of the study protocol or likely to be non-compliant with any study requirements
- Cohort 1:
- Hemoglobin, hematocrit, white blood cell count, or platelet count less than the lower limit of normal range of the reference laboratory, unless deemed not CS by an Investigator
- Current or anticipated concomitant medications, defined as the use of any over the counter (OTC) medications within 7 days prior to study drug administration or use of prescription medications, health supplements, and herbal remedies taken within 14 days prior to study drug administration Exceptions: Hormonal contraceptives and intermittent, as-needed acetaminophen or non-steroidal anti-inflammatory drugs (NSAIDs) for the treatment of transient headache or other minor ache/pain. Discussion between the Principal Investigator and the Sponsor's Medical Monitor is encouraged regarding the acceptability of any medications prior to study drug administration.
- Cohorts 2 to 5:
- Hemoglobin < 10.0 g/dL, white blood cell < 3,000 cells/L, or platelet count < 100,000 cells/L
- Current or anticipated concomitant medications with the exception of hormonal contraceptives, as-needed acetaminophen or NSAIDs for the treatment of transient, minor aches/pain, or any medication deemed essential for the management of renal impairment and the treatment of concomitant stable medical conditions as per the discretion of the Investigator.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Advanced Pharma CR
Miami, Florida, 33147
Orlando Clinical Research Center
Orlando, Florida, 32809
Nucleus Network
Saint Paul, Minnesota, 55114
About this study
Official title: A Phase 1, Multicenter, Open-Label, Parallel-Group Study to Assess the Safety and Pharmacokinetics of Oral Epetraborole Tablets in Adult Subjects With Varying Degrees of Renal Function
This is a Phase 1 study to evaluate the pharmacokinetics (PK), safety and tolerability of epetraborole tablets in adult subjects with normal renal function, subjects with various degrees of renal impairment, and subjects with end-stage renal disease (ESRD) receiving intermittent hemodialysis (IHD) therapy.
Read the detailed description
This is a multicenter, open-label, non-randomized, parallel group study in which a total of 40 subjects will be enrolled in one of 5 cohorts (8 subjects per cohort). Subjects will be enrolled based on their estimated glomerular filtration rate (eGFR) calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
- Cohort 1: Normal renal function (eGFR ≥ 90 mL/min/1.73 m2)
- Cohort 2: Mild renal impairment (eGFR ≥ 60 and < 90 mL/min/1.73 m2)
- Cohort 3: Moderate renal impairment (eGFR ≥ 30 and < 60 mL/min/1.73 m2)
- Cohort 4: Severe renal impairment (eGFR < 30 mL/min/1.73 m2)
- Cohort 5: ESRD (eGFR < 15 mL/min/1.73 m2) receiving IHD. Subjects must be stable and receiving IHD at least 3 times a week for at least 3 months prior to Screening.
- Conditions
- Renal Insufficiency
- Being tested
- Epetraborole
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpetraboroleDrug
Also called AN2-501971
Epetraborole hydrochloride 250 mg tablets for oral administration
| Study group | Role | What they receive |
|---|---|---|
| Open Label | Experimental | All subjects in Cohorts 1-4 receive 500 mg epetraborole once; Subjects on Cohort 5 receive 500 mg epetraborole twice Receives: Drug: Epetraborole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize the PK Profile of Epetraborole and M3: Maximum Plasma Concentration
Determination of the maximum observed plasma concentration (Cmax)
Measured: Cohorts 1-4: Day 1 to Day 4; Cohort 5: Day 1 - Day 8
Characterize the PK Profile of Epetraborole and M3: Area Under the Plasma Concentration Versus Time Curve from Time 0 to the Last Time Point Evaluated
Determine the area under the plasma concentration versus time curve from time 0 to the last time point evaluated (AUC0-t)
Measured: Cohorts 1-4: Day 1 to Day 4; Cohort 5: Day 1 - Day 8
Characterize the PK Profile of Epetraborole and M3: Area Under the Plasma Concentration Versus Time Curve from Time 0 to 24 hours
Determine the area under the plasma concentration versus time curve from time 0 to 24 hours (AUC0-24)
Measured: Cohorts 1-4: Day 1 to Day 4; Cohort 5: Day 1 - Day 8
Characterize the PK Profile of Epetraborole and M3: Area Under the Plasma Concentration Versus Time Curve from Time 0 to Infinity
Determine area under the drug concentration versus time curve, from time zero to infinity (AUC0-∞)
Measured: Cohorts 1-4: Day 1 to Day 4; Cohort 5: Day 1 - Day 8
Characterize the PK Profile of Epetraborole and M3: Apparent total plasma clearance of drug
Determine the apparent total plasma clearance of drug (CL/F)
Measured: Cohorts 1-4: Day 1 to Day 4; Cohort 5: Day 1 - Day 8
Characterize the PK Profile of Epetraborole and M3: Time to Maximum Plasma Concentration
Determination the time to maximum plasma concentration (Tmax)
Measured: Cohorts 1-4: Day 1 to Day 4; Cohort 5: Day 1 - Day 8
Characterize the PK Profile of Epetraborole: Plasma from Hemodialysis Flow
Determine the AUC from 0 to the last quantifiable concentration AUClast immediately after the end of dialysis period from inflow (arterial) line
Measured: Cohort 5: Day 5
Characterize the PK Profile of Epetraborole:Plasma from Hemodialysis Flow
Determine the AUC from 0 to the last quantifiable concentration AUClast immediately after the end of dialysis period from inflow (venous) line
Measured: Cohort 5: Day 5
Characterize the PK Profile of Epetraborole and M3 in Urine: Cumulative drug excreted in urine over time
Determine the cumulative amount excreted over all time intervals (0 to T), calculated as the sum of all amounts excreted from each interval (t1-t2)
Measured: Cohorts 1-4: Day 1 to Day 4
Characterize the PK Profile of Epetraborole and M3 in Urine: Unchanged drug excreted in urine during the time interval
Determine the fraction of unchanged drug excreted in urine during the time interval (expressed in %, calculated) for parent drug only
Measured: Cohorts 1-4: Day 1 to Day 4; Cohort 5: Day 1 - Day 8
Characterize the PK Profile of Epetraborole and M3 in Urine: Renal Clearance
Determine renal clearance (Ae(0-t)/ AUC0-T) for parent drug only
Measured: Cohorts 1-4: Day 1 to Day 4; Cohort 5: Day 1 - Day 8
Characterize the PK Profile of Epetraborole and M3 in Dialysate: Concentration in full dialysate
Determine amount of drug measured in the whole dialysate volume during dialysis period
Measured: Cohort 5: Day 5
Characterize the PK Profile of Epetraborole and M3 in Urine: Dialysis clearance
Determine the Dialysis clearance over the dialysis period
Measured: Cohort 5: Day 5
Evaluate the Incidence of Treatment Emergent Adverse Events at Baseline and Through Study Completion
Incidence, relatedness, and severity of adverse events
Measured: Cohorts 1-4: Day 1 to Day 4; Cohort 5: Day 1 - Day 8
Evaluate Changes in Clinical Laboratory Tests from Baseline Through Study Completion
Incidence of changes in clinical laboratory measurements from baseline
Measured: Cohorts 1-4: Day 1 to Day 4; Cohort 5: Day 1 - Day 8
Evaluate Change in Vital Signs from Baseline Through Study Completion
Incidence of changes in blood pressure, pulse, respiratory rate, and temperature
Measured: Cohorts 1-4: Day 1 to Day 4; Cohort 5: Day 1 - Day 8
Evaluate Changes in 12-lead ECG Measurements from Baseline Through Study Completion
Incidence of changes in 12-lead ECG parameters from baseline
Measured: Cohorts 1-4: Day 1 to Day 4; Cohort 5: Day 1 - Day 8
Evaluate Physical Examination Abnormalities from Baseline Through Study Completion
Incidence of physical exam abnormalities
Measured: Cohorts 1-4: Day 1 to Day 4; Cohort 5: Day 1 - Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start21 Feb 2022
- Primary completion10 Jun 2022
- Study completion27 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InsufficiencyStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- AN2 Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kimberly S Cruz, MD, Principal investigator, Advanced Pharma CR LLCThomas C Marbury, MD, Principal investigator, Orlando Clinical Research CenterGeorge C Canas, MD, Principal investigator, Nucleus Network Pty Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283746
- Sponsor's protocol ID
- EBO-102
- Status last verified
- Jul 2022
- First submitted
- 17 Feb 2022
- Last updated
- 15 Jul 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 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Open-Label, Parallel-Group Study to Assess the Safety and Pharmacokinetics of Oral Epetraborole Tablets in Adult Subjects With Varying Degrees of Renal Function
- ClinicalTrials.gov ID
- NCT05283746
- Acronym / sponsor ID
- EBO-102
- Conditions
- Renal Insufficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AN2 Therapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 10 Jun 2022 (actual)
- Study completion
- 27 Jun 2022 (actual)
- First posted
- 17 Mar 2022 (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.
This is a Phase 1 study to evaluate the pharmacokinetics (PK), safety and tolerability of epetraborole tablets in adult subjects with normal renal function, subjects with various degrees of renal impairment, and subjects with end-stage renal disease (ESRD) receiving intermittent hemodialysis (IHD) therapy.
Detailed description
This is a multicenter, open-label, non-randomized, parallel group study in which a total of 40 subjects will be enrolled in one of 5 cohorts (8 subjects per cohort). Subjects will be enrolled based on their estimated glomerular filtration rate (eGFR) calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
- Cohort 1: Normal renal function (eGFR ≥ 90 mL/min/1.73 m2)
- Cohort 2: Mild renal impairment (eGFR ≥ 60 and < 90 mL/min/1.73 m2)
- Cohort 3: Moderate renal impairment (eGFR ≥ 30 and < 60 mL/min/1.73 m2)
- Cohort 4: Severe renal impairment (eGFR < 30 mL/min/1.73 m2)
- Cohort 5: ESRD (eGFR < 15 mL/min/1.73 m2) receiving IHD. Subjects must be stable and receiving IHD at least 3 times a week for at least 3 months prior to Screening.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label | Experimental | Drug: EpetraboroleAll subjects in Cohorts 1-4 receive 500 mg epetraborole once; Subjects on Cohort 5 receive 500 mg epetraborole twice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- All subjects:
Key exclusion criteria (20 listed)
- Female who is lactating or is pregnant according to the pregnancy test at Screening or prior to the first study drug administration
- Any CS medical history or abnormal findings upon physical examination, or clinical laboratory tests, not specifically excluded in other criteria below that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject
- QTcF interval duration > 500 msec obtained as an average from the triplicate ECGs taken at least 1 minute apart after at least 5 minutes in a semi-supine, quiet rest position at Screening or prior to the first study drug administration
- Results of biochemistry tests for alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin greater than 1.5 × the upper limit of normal (ULN) for the reference laboratory, or history of chronic liver disease, cirrhosis, or biliary disease. For subjects with Gilbert's Syndrome, the subject may be included in the study at the discretion of the Investigator if the bilirubin levels are within the range for this condition.
- Recent history (within 6 months) of known or suspected Clostridioides difficile infection
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 |
|---|---|---|
| EpetraboroleAlso: AN2-501971Epetraborole hydrochloride 250 mg tablets for oral administration | Drug | Open Label |
Primary outcome
Characterize the PK Profile of Epetraborole and M3: Maximum Plasma Concentration
Time frame: Cohorts 1-4: Day 1 to Day 4; Cohort 5: Day 1 - Day 8
Determination of the maximum observed plasma concentration (Cmax)
Characterize the PK Profile of Epetraborole and M3: Area Under the Plasma Concentration Versus Time Curve from Time 0 to the Last Time Point Evaluated
Time frame: Cohorts 1-4: Day 1 to Day 4; Cohort 5: Day 1 - Day 8
Determine the area under the plasma concentration versus time curve from time 0 to the last time point evaluated (AUC0-t)
Characterize the PK Profile of Epetraborole and M3: Area Under the Plasma Concentration Versus Time Curve from Time 0 to 24 hours
Time frame: Cohorts 1-4: Day 1 to Day 4; Cohort 5: Day 1 - Day 8
Determine the area under the plasma concentration versus time curve from time 0 to 24 hours (AUC0-24)
Characterize the PK Profile of Epetraborole and M3: Area Under the Plasma Concentration Versus Time Curve from Time 0 to Infinity
Time frame: Cohorts 1-4: Day 1 to Day 4; Cohort 5: Day 1 - Day 8
Determine area under the drug concentration versus time curve, from time zero to infinity (AUC0-∞)
Characterize the PK Profile of Epetraborole and M3: Apparent total plasma clearance of drug
Time frame: Cohorts 1-4: Day 1 to Day 4; Cohort 5: Day 1 - Day 8
Determine the apparent total plasma clearance of drug (CL/F)
Characterize the PK Profile of Epetraborole and M3: Time to Maximum Plasma Concentration
Time frame: Cohorts 1-4: Day 1 to Day 4; Cohort 5: Day 1 - Day 8
Determination the time to maximum plasma concentration (Tmax)
Characterize the PK Profile of Epetraborole: Plasma from Hemodialysis Flow
Time frame: Cohort 5: Day 5
Determine the AUC from 0 to the last quantifiable concentration AUClast immediately after the end of dialysis period from inflow (arterial) line
Characterize the PK Profile of Epetraborole:Plasma from Hemodialysis Flow
Time frame: Cohort 5: Day 5
Determine the AUC from 0 to the last quantifiable concentration AUClast immediately after the end of dialysis period from inflow (venous) line
Characterize the PK Profile of Epetraborole and M3 in Urine: Cumulative drug excreted in urine over time
Time frame: Cohorts 1-4: Day 1 to Day 4
Determine the cumulative amount excreted over all time intervals (0 to T), calculated as the sum of all amounts excreted from each interval (t1-t2)
Characterize the PK Profile of Epetraborole and M3 in Urine: Unchanged drug excreted in urine during the time interval
Time frame: Cohorts 1-4: Day 1 to Day 4; Cohort 5: Day 1 - Day 8
Determine the fraction of unchanged drug excreted in urine during the time interval (expressed in %, calculated) for parent drug only
Characterize the PK Profile of Epetraborole and M3 in Urine: Renal Clearance
Time frame: Cohorts 1-4: Day 1 to Day 4; Cohort 5: Day 1 - Day 8
Determine renal clearance (Ae(0-t)/ AUC0-T) for parent drug only
Characterize the PK Profile of Epetraborole and M3 in Dialysate: Concentration in full dialysate
Time frame: Cohort 5: Day 5
Determine amount of drug measured in the whole dialysate volume during dialysis period
Characterize the PK Profile of Epetraborole and M3 in Urine: Dialysis clearance
Time frame: Cohort 5: Day 5
Determine the Dialysis clearance over the dialysis period
Evaluate the Incidence of Treatment Emergent Adverse Events at Baseline and Through Study Completion
Time frame: Cohorts 1-4: Day 1 to Day 4; Cohort 5: Day 1 - Day 8
Incidence, relatedness, and severity of adverse events
Evaluate Changes in Clinical Laboratory Tests from Baseline Through Study Completion
Time frame: Cohorts 1-4: Day 1 to Day 4; Cohort 5: Day 1 - Day 8
Incidence of changes in clinical laboratory measurements from baseline
Evaluate Change in Vital Signs from Baseline Through Study Completion
Time frame: Cohorts 1-4: Day 1 to Day 4; Cohort 5: Day 1 - Day 8
Incidence of changes in blood pressure, pulse, respiratory rate, and temperature
Evaluate Changes in 12-lead ECG Measurements from Baseline Through Study Completion
Time frame: Cohorts 1-4: Day 1 to Day 4; Cohort 5: Day 1 - Day 8
Incidence of changes in 12-lead ECG parameters from baseline
Evaluate Physical Examination Abnormalities from Baseline Through Study Completion
Time frame: Cohorts 1-4: Day 1 to Day 4; Cohort 5: Day 1 - Day 8
Incidence of physical exam abnormalities
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 15 Jul 2022.
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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.
Kimberly S Cruz, MD principal investigator
Advanced Pharma CR LLC
Thomas C Marbury, MD principal investigator
Orlando Clinical Research Center
George C Canas, MD principal investigator
Nucleus Network Pty Ltd.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Epetraborole in people with Renal Insufficiency, run by AN2 Therapeutics, Inc at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 20 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 15 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize the PK Profile of Epetraborole and M3: Maximum Plasma Concentration (time frame: Cohorts 1-4: Day 1 to Day 4; Cohort 5: Day 1 - Day 8). The study lists 18 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 15 Jul 2022.