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 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
NCT ID:
NCT02897869
Eligibility Criteria:
Inclusion Criteria:
* Healthy male and female (of non-childbearing potential) subjects between 18 to 55 years of age (inclusive)
* BMI between 18.0-30.0 kg/m2
* Creatinine clearance estimated by Cockroft Gault formula \> 80 mL/min and \< 160 ml/min (for males), or \< 150ml/min (females)
* Non smokers
* Normal audiogram.
Exclusion Criteria:
* History or suspicion of alcohol and/or drug abuse in the last 5 years
* Within 2 months prior to screening: exposure to aminoglycoside antibiotic, chemotherapy, or current use of loop diuretics
* Regular consumption of large amounts of xanthine
* Any medication that inhibits active tubular secretion within 4 weeks prior to first dosing
* Infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV)
* Any signs of renal impairment
* Clinically significant abnormalities (e.g. cardiovascular, laboratory values)
* Clinically significant abnormal ECG
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02897869
Study Brief:
Protocol Section:
NCT02897869