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500 mg epetraborole for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by AN2 Therapeutics, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study day 1 through study day 14
Awards & highlights

Study Summary

This trial studies heart rate & electrical activity of the heart when given a drug to see if it's safe.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study day 1 through study day 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and study day 1 through study day 14 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes to QTc interval
Secondary outcome measures
Analysis of dQTc
Assay sensitivity
Effect of epetraborole plasma concentrations on other ECG parameters on HR.
+22 more

Side effects data

From 2012 Phase 1 trial • 328 Patients • NCT01999114
53%
Infrequent bowel movements
45%
Nausea
42%
Headache
27%
Dizziness
24%
Vomiting
18%
Application site pruritus
15%
Application site irritation
14%
Abdominal discomfort
12%
Decreased appetite
11%
Somnolence
9%
Application site erythema
9%
Application site papules
8%
Fatigue
8%
Haematochezia
8%
Feeling hot
8%
Pruritus
8%
Hiccups
6%
Feeling drunk
6%
Diarrhoea
6%
Application site pustules
6%
Oropharyngeal pain
6%
Abdominal pain
6%
Dysuria
5%
Application site pain
3%
Flatulence
3%
Application site rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
BTDS
BTDS With Naltrexone
Naltrexone
Moxifloxacin
Placebo

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: 500 mg epetraboroleExperimental Treatment1 Intervention
500 mg epetraborole
Group II: 2000 mg epetraboroleExperimental Treatment1 Intervention
2000 mg epetraborole
Group III: 400 mg moxifloxacinActive Control1 Intervention
400 mg moxifloxacin
Group IV: Epetraborole-matching placeboPlacebo Group2 Interventions
Epetraborole-matching placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Epetraborole
2022
Completed Phase 1
~120

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AN2 Therapeutics, IncLead Sponsor
4 Previous Clinical Trials
605 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research opportunity extend to individuals over 35 years in age?

"This medical study is searching for participants who are within the age range of 18 and 65."

Answered by AI

Have any potential participants been accepted into this experiment yet?

"Clinicaltrials.gov shows that this clinical trial is actively searching for patients; the study was first put up on June 5th 2023 and revised most recentlyon August 8th 2023."

Answered by AI

Is eligibility for this clinical experiment open to me?

"This research project's criterion for admission is relatively straightforward: the patient must be of sound health and lie within the age range of 18 - 65. The current enrolment goal is 24 individuals."

Answered by AI

What are the potential risks associated with consuming 500 mg of epetraborole?

"Due to limited clinical research, 500 mg epetraborole was assigned a score of 1 in terms of safety. As it is only undergoing its first phase trial, data for both efficacy and safety are still emerging."

Answered by AI

What is the current enrollment of participants in this research endeavor?

"Indeed, the data furnished on clinicaltrials.gov affirms that enrollment is ongoing for this research programme, which was first announced on June 5th 2023 and most recently updated August 8th of the same year. This study requires 24 individuals at 1 test site to join in order to be successful."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Assess the Effects of Epetraborole on the QT Interval in Healthy Adult Subjects
2023. "A Study to Assess the Effects of Epetraborole on the QT Interval in Healthy Adult Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05995444.
~13 spots leftby Apr 2025
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