ADME Study of Acoziborole in Healthy Subjects (NCT04270981) | Clinical Trial Compass
CompletedPhase 1
ADME Study of Acoziborole in Healthy Subjects
United Kingdom6 participantsStarted 2020-02-05
Plain-language summary
This is a single centre, open-label, single group, non-randomised, single oral dose study in healthy male subjects designed to assess the mass balance recovery, PK, metabolite profile and metabolite identification, and exploratory pharmacodynamics of acoziborole. It is planned to enrol 6 subjects.
All subjects will receive an oral dose of 960 mg \[14C\] acoziborole on a single occasion as 4 capsules containing a small amount of radioactivity (not more than \[NMT\] 1000 nCi \[37 KBq\] 14C).
Who can participate
Age range
18 Years – 55 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy Caucasian males.
* Age 18 to 55 years of age at the time of signing informed consent.
* Body mass index (BMI) of 18.0 to 30.0 kg/m2 as measured at screening.
* Must be willing and able to communicate and participate in the whole study.
* Must have regular bowel movements (i.e., average stool production of ≥1 and ≤3 stools per day).
* Normal blood pressure (BP): Systolic BP between 90 and 140 (160 if \>45 years old) mmHg (inclusive), diastolic BP 45 to 90 mmHg (inclusive), measured after 10 min rest in supine position at screening and pre-dose.
* A resting heart rate (HR) between 45 and 100 bpm (inclusive), measured after 10 min rest in supine position at screening and pre-dose.
* ECG recording without clinically significant abnormality, including QTcF measure of ≤450 msec at screening and pre-dose.
* Must provide written informed consent.
* Must agree to adhere to the contraception requirements
* Subjects must be able to swallow multiple capsules.
Exclusion Criteria:
* Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1.
* Subjects who are study site employees, or immediate family members of a study site or sponsor employee.
* History of any drug or alcohol abuse in the past 2 years
* Regular alcohol consumption \>21 units per week and (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type) as confirmed by a positive alcohol breath test at scr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.