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 range18 Years – 55 Years
SexMALE
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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…