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 @ 7:44 PM
Ignite Modification Date:
2025-12-24 @ 7:44 PM
NCT ID:
NCT01832103
Eligibility Criteria:
Inclusion Criteria:
* Body mass index (BMI) 18 to 35 kg/m\^2
* Nonsmoker and/or have not used nicotine or nicotine-containing products
for at least 3 months prior to enrollment
* Estimated glomerular filtration rate (eGFR) 30 to 60 mL/min/1.73 m\^2
Exclusion Criteria:
* History of stroke, chronic seizures, or major neurological disorder
* Ongoing, clinically significant endocrine, gastrointestinal, cardiovascular,
hematological, hepatic, immunological, respiratory, or genitourinary abnormalities or diseases
* Systolic blood pressure (SBP) ≤95 mmHg or \>160 mmHg, or diastolic blood
pressure (DBP) ≤45 mmHg or \>95 mmHg
* History of neoplastic disease except for adequately treated non-melanomatous skin carcinoma
* Unable to refrain from, or anticipates the use of, strong/moderate cytochrome P450 3A4 (CYP3A4) inhibitors
* Consumes excessive amounts of alcohol, defined as greater than 3 glasses of alcoholic beverages, wine, or distilled spirits per day
* Consumes excessive amounts of caffeine, defined as greater than 6 servings of coffee, tea, cola, or other caffeinated beverages per day
* Had major surgery or donated blood within 8 weeks prior to enrollment
* Has participated in another investigational study within 4 weeks prior
* History of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerance to prescription or nonprescription drugs or food
* Currently a regular user of illicit drugs, or has a history of drug (including alcohol) abuse within approximately 6 months
* Has active or has a history of nephrolithiasis
* Has had a kidney removed or has a functioning renal transplant
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01832103
Study Brief:
Protocol Section:
NCT01832103