Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-24 @ 7:18 PM
NCT ID:
NCT03886103
Eligibility Criteria:
Inclusion Criteria:
* Healthy Caucasian males
* Age 30 to 65 years
* BMI 18.5 to 32.0 kg/m2 and body weight of 55 to 95 kg.
* Must be willing and able to communicate and participate in the whole study
* Must have regular bowel movements (ie, average stool production of ≥1 and ≤3 stools per day)
* Must provide written informed consent
* Regular alcohol consumption of 4-14 units of alcohol per week (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)
* Must agree to adhere to the contraception
Exclusion Criteria:
* Subjects who have received any IMP in a clinical research study within the previous 3 months or 90 days prior to Day 1
* any drug or alcohol abuse
* Current smokers and those who have smoked within the last 12 months.
* Radiation exposure, including that from the present study, excluding background adiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years.
* No occupationally exposedworker, as defined in the Ionizing Radiation Regulations 2017, shall participate in the study
* Clinically significant abnormal biochemistry, hematology, coagulation or urinalysis as judged by the investigator
* Positive test for HIV, HBV, HBC
* eGFR \<80 mL/min
* History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or GI disease, neurological or psychiatric disorder, as judged by the investigator
* Known sensitivity to any of the constituents or excipients of the study drug or history of relevant drug and/or food allergy (anaphylactic, anaphylactoid reactions)
* History of drug-induced Torsade de Pointe or presence of a familial long QT syndrome
* Mental handicap
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
30 Years
Maximum Age:
65 Years
Study:
NCT03886103
Study Brief:
Protocol Section:
NCT03886103