Healthy VolunteersPhase 1NCT05995444
A Study to Assess the Effects of Epetraborole on the QT Interval in Healthy Adult Subjects
A Phase 1 study testing Epetraborole and Moxifloxacin in people with Healthy Volunteers, run by AN2 Therapeutics, Inc at 1 site in United States.
Trial summary
A single-center, 4-way crossover study to evaluate the effect of single therapeutic and supratherapeutic oral doses of epetraborole on the heart rate (HR) corrected QT interval (QTc) by assessing concentration-QT (C-QT) relationship using exposure-response modeling. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Epetraborole and Moxifloxacin
- 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
- 5 Jun 2023to 3 Aug 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Adult, male or female, 18-65 years of age, inclusive, at the screening visit.
- Subjects must agree to follow protocol-specified contraception guidance
- Continuous non smoker for at least 3 months prior to the first dosing based on subject self-reporting
- Body mass index (BMI) 18.0 and 32.0 kg/m2 at the screening visit.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, and vital signs, as deemed by the Investigator or designee.
- No clinically significant history or presence of ECG findings as judged by the Investigator or designee at the screening visit and first check-in
Who cannot join
- Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- History or presence of clinically significant medical or psychiatric condition or disease that, in the opinion of the Investigator or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
- Presence of bacterial infections requiring the use of antibiotic therapy within 3 months prior to the first dosing.
- History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing.
- 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 the first dosing.
- History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds (e.g., fluoroquinolones, epetraborole excipients), or allergy to ECG electrode adhesive patches or adhesive dressings/medical tape.
Show all 20Show fewer
- History or presence of any of the following, deemed clinically significant by the Investigator or qualified designee:
- Ventricular pre-excitation syndrome (Wolff Parkinson White syndrome)
- Arrhythmia or history of arrhythmia requiring medical intervention
- Risk factors for TdP (e.g., heart failure, cardiomyopathy, family history of Long QT Syndrome, or sudden unexpected cardiac death at a young age)
- Sick sinus syndrome, second- or third-degree atrioventricular block, myocardial infarction, pulmonary congestion, symptomatic or significant cardiac arrhythmia, prolonged QTcF interval, or conduction abnormalities
- Is lactating or has a positive pregnancy test at the screening visit or first check-in (females only).
- Positive urine drug or alcohol results at the screening visit or first check-in.
- Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at the screening visit.
- Positive results for coronavirus disease 2019 (COVID-19) at first check-in.
- Unable to refrain from or anticipates the use of any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning
- 14 days prior to the first dosing.
- 13. Has been on a diet incompatible with the on-study diet, in the opinion of the Investigator or designee, within the 30 days prior to the first dosing.
- 14. Donation of blood or blood products or significant blood loss within 56 days prior to the first dosing or plans to donate blood products through the follow-up contact.
- 15. Participation in another clinical study and received an investigational agent within 30 days or within 5 half-lives (if known), prior to the first dosing, whichever is longer. The 30-day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of Period 1 of the current study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Single-Dose, Randomized, Placebo- and Positive-Control, Four-Way, Crossover Study for the Evaluation of the Effect of Epetraborole on QT Intervals in Healthy Adult Subjects
A single-center, 4-way crossover study to evaluate the effect of single therapeutic and supratherapeutic oral doses of epetraborole on the heart rate (HR) corrected QT interval (QTc) by assessing concentration-QT (C-QT) relationship using exposure-response modeling.
Read the detailed description
On Day 1 of each period, subjects will receive 1 of 4 treatments: a single therapeutic dose of epetraborole (Treatment A), a single supratherapeutic dose of epetraborole (Treatment B), a single dose of epetraborole-matching placebo (Treatment C), or a single dose of moxifloxacin (Treatment D). Cardiodynamic ECGs and PK blood samples for epetraborole, metabolite M3, and moxifloxacin (as applicable) will be collected predose and for 24 hours postdose in each period.
There will be a washout of at least 10 days between doses.
- Conditions
- Healthy Volunteers
- Being tested
- Epetraborole and matching placebo, Epetraborole, Placebo, Moxifloxacin
- Keywords
- QTc, Epetraborole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epetraborole and matching placeboDrug
Also called Therapeutic
Treatment A (Therapeutic): 500 mg epetraborole (2 x 250 mg tablets) and epetraborole matching-placebo (6 tablets)
EpetraboroleDrug
Also called Supratherapeutic
Treatment B (Supratherapeutic): 2000 mg epetraborole (8 x 250 mg tablets)
PlaceboDrug
Also called Placebo Control
Treatment C (Placebo control): Epetraborole matching-placebo (8 tablets)
MoxifloxacinDrug
Also called Positive Control
Treatment D (Positive control): 400 mg moxifloxacin (1 x 400 mg tablet)
| Study group | Role | What they receive |
|---|---|---|
| 500 mg epetraborole | Experimental | 500 mg epetraborole Receives: Drug: Epetraborole |
| 2000 mg epetraborole | Experimental | 2000 mg epetraborole Receives: Drug: Epetraborole |
| Epetraborole-matching placebo | Placebo comparator | Epetraborole-matching placebo Receives: Drug: Epetraborole and matching placebo; Drug: Placebo |
| 400 mg moxifloxacin | Active comparator | 400 mg moxifloxacin Receives: Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes to QTc interval
Effect of epetraborole plasma concentrations on the QTc interval using linear mixed effect exposure-response modeling, including the predicted ddQTc at Cmax values corresponding to exposure levels of interest.
Measured: Study Day -1 to Study Day 2
Secondary outcomes (25)
Effect of epetraborole plasma concentrations on other ECG parameters on QTc
Measure the Effect of epetraborole plasma concentrations on other ECG parameters on QTc
Measured: Study Day -1 to Study Day 2
Assay sensitivity
Assay sensitivity assessment with ddQTc at the geometric mean Cmax value predicted from a linear mixed effect model evaluating the relationship between QTc and moxifloxacin plasma concentrations (exposure-response modeling).
Measured: Study Day -1 to Study Day 2
Analysis of dQTc
QTc interval using a mixed effect analysis of covariance (ANCOVA) carried out as appropriate to analyze dQTc at each time point post baseline.
Measured: Study Day -1 to Study Day 2
PK Concentration analysis for epetraborole and metabolite M3 of AUC0 t
Analysis of PK Concentration for epetraborole and metabolite M3 of AUC0 t
Measured: Study Day -1 to Study Day 2
Evaluation of TEAEs
TEAEs
Measured: Study Day 1 through Study Day 14
Safety Vital Signs changes of body temperature
Measure Safety Vital Signs changes of body temperature
Measured: Study Day 1 through Study Day 14
Orthostatic Vital Signs changes of Heart Rate from supine to standing position.
Measure Orthostatic Vital Signs changes of Heart Rate from supine to standing position.
Measured: Study Day 1 through Study Day 14
Effect of epetraborole plasma concentrations on other ECG parameters on, PR
Measure the Effect of epetraborole plasma concentrations on other ECG parameters on, PR
Measured: Study Day -1 to Study Day 2
Effect of epetraborole plasma concentrations on other ECG parameters on QRS duration
Measure the Effect of epetraborole plasma concentrations on other ECG parameters on QRS duration.
Measured: Study Day -1 to Study Day 2
Effect of epetraborole plasma concentrations on other ECG parameters on HR.
Measure the Effect of epetraborole plasma concentrations on other ECG parameters on HR.
Measured: Study Day -1 to Study Day 2
PK Concentration analysis for epetraborole and metabolite M3 of AUC0 inf
Analysis of PK Concentration for epetraborole and metabolite M3 of AUC0 inf
Measured: Study Day -1 to Study Day 2
PK Concentration analysis for epetraborole and metabolite M3 of AUC%extrap
Analysis of PK Concentration for epetraborole and metabolite M3 of AUC%extrap
Measured: Study Day -1 to Study Day 2
PK Concentration analysis for epetraborole and metabolite M3 of Cmax
Analysis of PK Concentration for epetraborole and metabolite M3 of Cmax
Measured: Study Day -1 to Study Day 2
PK Concentration analysis for epetraborole and metabolite M3 of Tmax
Analysis of PK Concentration for epetraborole and metabolite M3 of Tmax
Measured: Study Day -1 to Study Day 2
PK Concentration analysis for epetraborole and metabolite M3 of Kel
Analysis of PK Concentration for epetraborole and metabolite M3 of Kel
Measured: Study Day -1 to Study Day 2
PK Concentration analysis for epetraborole and metabolite M3 of t½
Analysis of PK Concentration for epetraborole and metabolite M3 of t½
Measured: Study Day -1 to Study Day 2
PK Concentration analysis for epetraborole and metabolite M3 of CL/F (parent only),
Analysis of PK Concentration for epetraborole and metabolite M3 of CL/F (parent only),
Measured: Study Day -1 to Study Day 2
PK Concentration analysis for epetraborole and metabolite M3 of Vz/F (parent only)
Analysis of PK Concentration for epetraborole and metabolite M3 of Vz/F (parent only
Measured: Study Day -1 to Study Day 2
PK Concentration analysis for epetraborole and metabolite M3 of MR AUC0 t
Analysis of PK Concentration for epetraborole and metabolite M3 of MR AUC0 t
Measured: Study Day -1 to Study Day 2
PK Concentration analysis for epetraborole and metabolite M3 of MR AUC0 inf
Analysis of PK Concentration for epetraborole and metabolite M3 of MR AUC0 inf
Measured: Study Day -1 to Study Day 2
PK Concentration analysis for epetraborole and metabolite M3 of MR Cmax
Analysis of PK Concentration for epetraborole and metabolite M3 of MR Cmax
Measured: Study Day -1 to Study Day 2
Safety Vital Signs changes of respiratory rate
Measure Safety Vital Signs changes of respiratory rate
Measured: Study Day 1 through Study Day 14
Safety Vital Signs changes of blood pressure
Measure Safety Vital Signs changes of blood pressure (systolic and diastolic)
Measured: Study Day 1 through Study Day 14
Safety Vital Signs changes of heart rate
measure Safety Vital Signs changes of heart rate
Measured: Study Day 1 through Study Day 14
Orthostatic Vital Signs changes of blood pressure from supine to standing position.
Measure Orthostatic Vital Signs changes of blood pressure from supine to standing position (systolic and diastolic).
Measured: Study Day 1 through Study Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start5 Jun 2023
- Primary completion26 Jul 2023
- Study completion3 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Screening of subjects will occur within 28 days prior to the first dosing. Subjects will be housed on Day -1, at the time indicated by the CRU, until completion of study procedures on Day 2 of each period. On Day 1 of each period, subjects will receive 1 of 4 treatments: a single therapeutic dose of epetraborole (Treatment A), a single supratherapeutic dose of epetraborole (Treatment B), a single dose of epetraborole matching-placebo (Treatment C), or a single dose of moxifloxacin (Treatment D). Cardiodynamic ECGs and PK blood samples for epetraborole, metabolite M3, and moxifloxacin (as applicable) will be collected predose and for 24 hours postdose in each period. There will be a washout of at least 10 days between doses. Safety will be monitored throughout the study by repeated clinical and laboratory evaluations, including a follow-up visit approximately 14 days after the last dose.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- AN2 Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995444
- Sponsor's protocol ID
- EBO-104
- Status last verified
- Aug 2023
- First submitted
- 27 Jun 2023
- Last updated
- 21 Dec 2023
- 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 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Dose, Randomized, Placebo- and Positive-Control, Four-Way, Crossover Study for the Evaluation of the Effect of Epetraborole on QT Intervals in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05995444
- Acronym / sponsor ID
- EBO-104
- Conditions
- Healthy Volunteers
- Keywords
- QTc, Epetraborole
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AN2 Therapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 26 Jul 2023 (actual)
- Study completion
- 3 Aug 2023 (actual)
- First posted
- 16 Aug 2023 (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.
A single-center, 4-way crossover study to evaluate the effect of single therapeutic and supratherapeutic oral doses of epetraborole on the heart rate (HR) corrected QT interval (QTc) by assessing concentration-QT (C-QT) relationship using exposure-response modeling.
Detailed description
On Day 1 of each period, subjects will receive 1 of 4 treatments: a single therapeutic dose of epetraborole (Treatment A), a single supratherapeutic dose of epetraborole (Treatment B), a single dose of epetraborole-matching placebo (Treatment C), or a single dose of moxifloxacin (Treatment D). Cardiodynamic ECGs and PK blood samples for epetraborole, metabolite M3, and moxifloxacin (as applicable) will be collected predose and for 24 hours postdose in each period.
There will be a washout of at least 10 days between doses.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Screening of subjects will occur within 28 days prior to the first dosing. Subjects will be housed on Day -1, at the time indicated by the CRU, until completion of study procedures on Day 2 of each period. On Day 1 of each period, subjects will receive 1 of 4 treatments: a single therapeutic dose of epetraborole (Treatment A), a single supratherapeutic dose of epetraborole (Treatment B), a single dose of epetraborole matching-placebo (Treatment C), or a single dose of moxifloxacin (Treatment D). Cardiodynamic ECGs and PK blood samples for epetraborole, metabolite M3, and moxifloxacin (as applicable) will be collected predose and for 24 hours postdose in each period. There will be a washout of at least 10 days between doses. Safety will be monitored throughout the study by repeated clinical and laboratory evaluations, including a follow-up visit approximately 14 days after the last dose.
| Arm | Type | Receives |
|---|---|---|
| 500 mg epetraborole | Experimental | Drug: Epetraborole500 mg epetraborole |
| 2000 mg epetraborole | Experimental | Drug: Epetraborole2000 mg epetraborole |
| Epetraborole-matching placebo | Placebo comparator | Drug: Epetraborole and matching placebo, Drug: PlaceboEpetraborole-matching placebo |
| 400 mg moxifloxacin | Active comparator | Drug: Moxifloxacin400 mg moxifloxacin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Adult, male or female, 18-65 years of age, inclusive, at the screening visit.
- Subjects must agree to follow protocol-specified contraception guidance
- Continuous non smoker for at least 3 months prior to the first dosing based on subject self-reporting
- Body mass index (BMI) 18.0 and 32.0 kg/m2 at the screening visit.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, and vital signs, as deemed by the Investigator or designee.
Key exclusion criteria (20 listed)
- Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- History or presence of clinically significant medical or psychiatric condition or disease that, in the opinion of the Investigator or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
- Presence of bacterial infections requiring the use of antibiotic therapy within 3 months prior to the first dosing.
- History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing.
- 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 the first dosing.
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 |
|---|---|---|
| Epetraborole and matching placeboAlso: TherapeuticTreatment A (Therapeutic): 500 mg epetraborole (2 x 250 mg tablets) and epetraborole matching-placebo (6 tablets) | Drug | Epetraborole-matching placebo |
| EpetraboroleAlso: SupratherapeuticTreatment B (Supratherapeutic): 2000 mg epetraborole (8 x 250 mg tablets) | Drug | 2000 mg epetraborole, 500 mg epetraborole |
| PlaceboAlso: Placebo ControlTreatment C (Placebo control): Epetraborole matching-placebo (8 tablets) | Drug | Epetraborole-matching placebo |
| MoxifloxacinAlso: Positive ControlTreatment D (Positive control): 400 mg moxifloxacin (1 x 400 mg tablet) | Drug | 400 mg moxifloxacin |
Primary outcome
Changes to QTc interval
Time frame: Study Day -1 to Study Day 2
Effect of epetraborole plasma concentrations on the QTc interval using linear mixed effect exposure-response modeling, including the predicted ddQTc at Cmax values corresponding to exposure levels of interest.
25 secondary outcomes
Effect of epetraborole plasma concentrations on other ECG parameters on QTc
Time frame: Study Day -1 to Study Day 2
Assay sensitivity
Time frame: Study Day -1 to Study Day 2
Analysis of dQTc
Time frame: Study Day -1 to Study Day 2
PK Concentration analysis for epetraborole and metabolite M3 of AUC0 t
Time frame: Study Day -1 to Study Day 2
Evaluation of TEAEs
Time frame: Study Day 1 through Study Day 14
Safety Vital Signs changes of body temperature
Time frame: Study Day 1 through Study Day 14
Orthostatic Vital Signs changes of Heart Rate from supine to standing position.
Time frame: Study Day 1 through Study Day 14
Effect of epetraborole plasma concentrations on other ECG parameters on, PR
Time frame: Study Day -1 to Study Day 2
Effect of epetraborole plasma concentrations on other ECG parameters on QRS duration
Time frame: Study Day -1 to Study Day 2
Effect of epetraborole plasma concentrations on other ECG parameters on HR.
Time frame: Study Day -1 to Study Day 2
PK Concentration analysis for epetraborole and metabolite M3 of AUC0 inf
Time frame: Study Day -1 to Study Day 2
PK Concentration analysis for epetraborole and metabolite M3 of AUC%extrap
Time frame: Study Day -1 to Study Day 2
PK Concentration analysis for epetraborole and metabolite M3 of Cmax
Time frame: Study Day -1 to Study Day 2
PK Concentration analysis for epetraborole and metabolite M3 of Tmax
Time frame: Study Day -1 to Study Day 2
PK Concentration analysis for epetraborole and metabolite M3 of Kel
Time frame: Study Day -1 to Study Day 2
PK Concentration analysis for epetraborole and metabolite M3 of t½
Time frame: Study Day -1 to Study Day 2
PK Concentration analysis for epetraborole and metabolite M3 of CL/F (parent only),
Time frame: Study Day -1 to Study Day 2
PK Concentration analysis for epetraborole and metabolite M3 of Vz/F (parent only)
Time frame: Study Day -1 to Study Day 2
PK Concentration analysis for epetraborole and metabolite M3 of MR AUC0 t
Time frame: Study Day -1 to Study Day 2
PK Concentration analysis for epetraborole and metabolite M3 of MR AUC0 inf
Time frame: Study Day -1 to Study Day 2
PK Concentration analysis for epetraborole and metabolite M3 of MR Cmax
Time frame: Study Day -1 to Study Day 2
Safety Vital Signs changes of respiratory rate
Time frame: Study Day 1 through Study Day 14
Safety Vital Signs changes of blood pressure
Time frame: Study Day 1 through Study Day 14
Safety Vital Signs changes of heart rate
Time frame: Study Day 1 through Study Day 14
Orthostatic Vital Signs changes of blood pressure from supine to standing position.
Time frame: Study Day 1 through Study Day 14
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 21 Dec 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Epetraborole and Moxifloxacin in people with Healthy Volunteers, run by AN2 Therapeutics, Inc 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 6 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 21 Dec 2023. 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. 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?
Changes to QTc interval (time frame: Study Day -1 to Study Day 2). 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 21 Dec 2023.