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 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT02117505
Eligibility Criteria:
Inclusion Criteria:
* Female participants must be either: 1) not of childbearing potential: postmenopausal or surgically sterile at screening 2) of child-bearing potential: Must use highly effective contraception consisting of 2 forms of birth control (1 of which must be a barrier method) starting at screening, and agree to use highly effective contraception throughout the study period, and for 90 days after final study drug administration. Women, who are not heterosexually active at Screening, must agree to utilize a highly-effective method of birth control if they become heterosexually active during their participation in the study
* Must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening; and a negative urine pregnancy test on Day (-)1 of Period 1
* Female participants must agree not to donate ova starting at screening and throughout the study period, and for 90 days after the final study drug administration
* If a man who is sexually active with a woman of child-bearing potential and has not had a vasectomy, must agree to use an adequate contraception method as deemed appropriate by the Investigator (for example, vasectomy, double-barrier, partner using effective contraception) and to not donate sperm during the study and for 90 days after receiving the last dose of study drug
* Participants eligible according to the following tuberculosis (TB) screening criteria: 1) following tuberculosis (TB) screening criteria 2) have no signs or symptoms suggestive of active TB upon medical history and/or physical examination 3) have had no recent close contact with a person with active TB 4. Within 2 months prior to the first administration of study agent, have a negative T-spot or QuantiFERON-TB Gold test result
Exclusion Criteria:
* History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection
* Participant had major gastrointestinal (GI) surgery
* Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or at admission to the study center on Day (-) 1 of Period 1
* Participant has an aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) greater than or equal to (\>=) the upper limit of normal (ULN)
* History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (4th edition) (DSM-IV) criteria within 1 year before Screening or positive test result(s) for alcohol and/or drugs of abuse (such as barbiturates, opiates, cocaine, cannabinoids, amphetamines and benzodiazepines) at screening or Day (-) 1 of Period 1
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02117505
Study Brief:
Protocol Section:
NCT02117505