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 @ 5:32 PM
Ignite Modification Date:
2025-12-24 @ 5:32 PM
NCT ID:
NCT03773068
Eligibility Criteria:
Inclusion criteria:
* Healthy male subject
* Age: 18 to 55 years (inclusive) at the time of informed consent and first dose of study medication
* Body mass index (BMI) above/equal to 18 and below/equal to 30 kg/m\^2 at Screening
* Body weight of at least 45 kg at Screening
Exclusion criteria:
* Presence or history of clinically relevant cardiovascular, central nervous system (CNS), hepatic, hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma hypoxemia, hypertension, seizures, or allergic skin rash
* Known hypersensitivity to the study drugs
* Known severe allergies or significant non-allergic drug reactions
* Febrile illness within 1 week before study drug administration
* Current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs
* Subject has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to Screening
* Poor peripheral venous access
* Regular use of medicines within 6 months prior to screening
* Clinically relevant findings in the electrocardiogram (ECG), physical examination or laboratory examination
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT03773068
Study Brief:
Protocol Section:
NCT03773068