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 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT02595268
Eligibility Criteria:
Inclusion Criteria:
* Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
* A female participant of childbearing potential must have a negative serum beta-human chorionic gonadotropin test at Screening and a negative urine pregnancy test on Day -1
* A female participant must agree not to donate eggs (ova, oocytes) throughout the study and for at least 90 days after receiving the last dose of study drug
* A male participant who is sexually active with a woman of childbearing potential must agree to use two effective methods of birth control, and all male participants must also agree not to donate sperm throughout the study and for 90 days after receiving the last dose of study drug
* Participant must have a body mass index (BMI; weight in kg divided by the square of height in meters) of 18.0 to 30.0 kilogram per square meter (kg/m\^2), extremes included
Exclusion Criteria:
* Participant has a history of any illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant or that could prevent, limit or confound the protocol specified assessments. This may include but is not limited to renal dysfunction \[calculated creatinine clearance below 60 milliliter per minute (mL/min) at Screening\], significant cardiac, vascular, pulmonary, gastrointestinal (such as significant diarrhea, gastric stasis, or constipation that in the Investigator's opinion could influence drug absorption or bioavailability), endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances, or a predisposition to myopathy
* Participants with one or more laboratory abnormalities as specified in protocol, at Screening as defined by the World Health Organization (WHO) Toxicity Grading Scale
* Participant with a past history of clinically significant heart arrhythmia (extrasystoli, tachycardia at rest) or of risk factors for Torsade de Pointes syndrome (example, hypokalemia, family history of long QT Syndrome)
* Participants with any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticaria
* Participants with a history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy witnessed in previous studies with experimental drugs
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02595268
Study Brief:
Protocol Section:
NCT02595268