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:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT03444818
Eligibility Criteria:
Inclusion Criteria:
* 30 to 55 years of age
* Body mass index between 18.5 and 30.0 kilograms per meters squared (kg/m\^2), and a total body weight between 50 and 100 kilograms (kg)
* In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead electrocardiogram, vital sign measurements, and clinical laboratory evaluations
* Males will agree to use contraception
* Able to comprehend and willing to sign an informed consent form and to abide by the study restrictions
Exclusion Criteria:
* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, and hernia repair will be allowed)
* Significant history or clinical manifestation of hemorrhoids
* History of alcoholism or drug/chemical abuse within 2 years prior to Check-in
* Positive hepatitis panel and/or positive human immunodeficiency virus test
* Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days prior to Check-in
* Use or intend to use any prescription medications/products within 14 days prior to Check-in
* Participants in receipt of a live vaccine within 30 days prior to the first dose administration or who plan to receive a live vaccine during the study and for 14 days after the dose of study drug
* Use of tobacco or nicotine containing products within 3 months prior to Check-in
* Receipt of blood products within 2 months prior to Check-in
* Donation of blood from 3 months prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening
* Participants with exposure to significant diagnostic or therapeutic radiation or current employment in a job requiring radiation exposure monitoring within 12 months prior to Check-in
* Participants who have participated in any clinical trial involving a radiolabelled investigational product within 12 months prior to Check-in
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
30 Years
Maximum Age:
55 Years
Study:
NCT03444818
Study Brief:
Protocol Section:
NCT03444818