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 @ 2:07 PM
Ignite Modification Date:
2025-12-24 @ 2:07 PM
NCT ID:
NCT03400995
Eligibility Criteria:
Inclusion Criteria:
* Healthy males
* Aged between 30 and 55 years of age, inclusive
* Body mass index of 18.0 to 35.0 kg/m2, inclusive, or, if outside the range, considered not clinically significant by the investigator and the medical monitor
* Must be willing and able to communicate and participate in the whole study
* Must have regular daily bowel movements
* Must provide written informed consent
* Must agree to use an adequate method of contraception
Exclusion Criteria:
* Subjects who have received any IMP in a clinical research study within the previous 3 months
* Subjects who are study site or sponsor employees, or immediate family members of a study site or sponsor employee
* Subjects who have previously been enrolled in this study
* History of any drug or alcohol abuse in the past 2 years
* Regular alcohol consumption \>21 units per week
* Current smokers and those who have smoked within the last 12 months
* Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
* Radiation exposure. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study
* Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
* Abnormal liver function as assessed by clinical chemistry
* Positive drugs of abuse test result
* Positive HBsAg, HCV Ab or HIV results
* Evidence of renal impairment at screening
* History of clinically significant cardiovascular, renal, hepatic, chronic respiratory, neurological, dermatological or GI disease, or psychiatric disorder, as judged by the investigator
* Any abnormality of ECG parameters
* Any abnormality of cardiac rhythm or history thereof
* Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
* Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed, unless it is active at screening or admission
* Donation or loss of greater than 400 mL of blood within the previous 3 months
* Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal or any other 'alternative' remedies in the 14 days before IMP administration
* Failure to satisfy the investigator of fitness to participate for any other reason
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
30 Years
Maximum Age:
55 Years
Study:
NCT03400995
Study Brief:
Protocol Section:
NCT03400995