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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT03569267
Eligibility Criteria:
Inclusion Criteria:
* Males or females, of any race, between 18 and 60 years of age, inclusive, at Screening.
* Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive, at Screening.
* In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG, vital sign measurements, and clinical laboratory evaluations (congenital non haemolytic hyperbilirubinaemia \[eg, Gilbert's syndrome\] is not acceptable) at Screening and/or Check in as assessed by the Investigator (or designee).
* Female subjects will be non pregnant and non lactating.
* Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
Exclusion Criteria:
* Male subjects who do not agree, or whose partners of childbearing potential do not agree, to use a male barrier method of contraception (ie, a male condom with spermicide) in addition to a second method of acceptable contraception used by their female partners or to refrain from donating sperm from Check in until 90 days after the Follow up Visit .
* Female subjects of childbearing potential who do not agree to use a highly effective method of birth control in conjunction with male barrier method contraception (ie, a male condom with spermicide) or to refrain from donating ova from the time of signing the ICF until 90 days after the Follow up Visit.
* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
* Subjects with serum creatinine \>ULN.
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
* History of alcoholism or drug/chemical abuse within 2 years prior to Check in.
* Alcohol consumption of \>28 units per week for males and \>21 units for females. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1⁄6 gill (25 mL) of spirits.
* Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at Screening and/or Check in.
* Positive hepatitis panel and/or positive human immunodeficiency test at Screening. Subjects whose results are compatible with prior immunisation and not infection may be included at the discretion of the Investigator.
* Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 3 months (or 5 half lives, whichever is longer) prior to Check in.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03569267
Study Brief:
Protocol Section:
NCT03569267