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 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
NCT ID:
NCT02179866
Eligibility Criteria:
Inclusion Criteria:
* Healthy male participants, 35 to 64 years of age, inclusive
* For men with a female partner of child-bearing potential: Agreement to use two methods of contraception, including one barrier method e.g. condom, during the treatment period and for at least 3 months after the last dose of study drug
* Participants who do not intend to donate sperm until at least 3 months after the last dose of the study drug
Exclusion Criteria:
* History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer or cirrhosis
* Any personal or familial history of seizures, epilepsy or other convulsive condition, previous significant head trauma, or other factors predisposing to seizures
* Any major illness within one month before the screening examination or any febrile illness within one week prior to screening and up to first dose administration
* Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to a subject
* History or presence of any clinically relevant ECG abnormalities, cardiovascular or cerebrovascular disease
* History of myopathy or muscle disorder
* History or evidence of any medical condition potentially altering the absorption, metabolism or elimination of drugs
* Any CYP3A inhibitor within 2 weeks or within 5 times the elimination half-life, whichever is longer, prior to dosing
* Any CYP3A inducer within 4 weeks or within 5 times the elimination half-life, whichever is longer, prior to dosing
* Infrequent bowel movements (less than once per 24 hours on average)
* Regular work with ionizing radiation or radioactive material
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
35 Years
Maximum Age:
64 Years
Study:
NCT02179866
Study Brief:
Protocol Section:
NCT02179866