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 @ 12:21 PM
Ignite Modification Date:
2025-12-24 @ 12:21 PM
NCT ID:
NCT04349761
Eligibility Criteria:
Inclusion Criteria:
* Written Informed Consent.
* Stable medical history and general health.
* Body weight between 60 - 100 kg and Body Mass Index (BMI) of 18-31 kg/m2.
* Estimated GFR (eGFR) - mL/min/1.73m2 or estimated creatinine clearance (CLcr) (mL) ≥90.
* Normal hepatic function.
* Adequate peripheral venous access.
* Test negative for HIV, hepatitis C virus antibodies, and hepatitis B surface antigen (HBsAg).
* Test negative for drugs of abuse.
* Willing and able to complete all study assessments and procedures and to communicate effectively with the Investigator and study center staff.
* Willing to use effective contraception from Day -1 until 90 days after receiving study medication.
Exclusion Criteria:
* Allergy to any product ingredients.
* Unable to swallow capsules.
* Elective medical procedure during study.
* Abusing drugs or alcohol and/or history of drug or alcohol dependence within 6 months of study entry.
* History of seizure disorder requiring medical treatment after 18 years of age.
* Current smoker or smokeless tobacco user.
* Participation in drug or medical device clinical study within 30 days of study. entry or 5 times half-life of study drug, whichever is longer.
* Medically significant standard clinical laboratory assessments.
* Significant medical condition which might interfere with the study or put subject at significant risk.
* QTcF \>450 ms or clinically significant ECG abnormalities.
* Elevation of blood pressure (BP) - Supine BP \>145mmHg; Diastolic BP. \>92mmHg;l heart rate (HR) \>100 bpm.
* Gastrointestinal malabsorption.
* Abnormal thyroid function (TSH, T4 and/or T3 levels): elevated thyroid antibodies (anti- TPO and/or anti-Thyroglobulin); thyroid goiter, or known thyroid nodule(s) at Baseline; \>Abnormal renal function (estimated GFR \>90mL/min/1.73m2 or estimated creatinine clearance \<90mL) and/or abnormal hepatic function at Baseline.
* Treatment with any prescription or nonprescription drugs, including vitamins, minerals, or herbal and dietary supplements, within 14 days or 5 half-lives of Day 1, whichever is longer - except Tylenol.
* Use within 30 days prior to Day 1 of any drugs or substances, including grapefruit juice, that are known to strongly inhibit or induce cytochrome P450 (CYP) enzymes.
* Donation of blood or blood product within 56 days of Day 1.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04349761
Study Brief:
Protocol Section:
NCT04349761