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 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT02442258
Eligibility Criteria:
Inclusion Criteria: All Subjects
* Females must have negative results for pregnancy tests performed:
* At Screening on a urine specimen, and
* On a serum sample obtained on Study Day -2 (prior to dosing).
* Body Mass Index (BMI) is ≥ 18 to ≤ 38 kg/m2, inclusive.
* Body Weight \> 50 kg.
Subjects with Normal Renal Function
In addition to the main inclusion criteria above for all subjects, the following criteria must be met for subjects with normal renal function enrolled in Group 5:
* Judged to be in general good health based upon the results of a medical history, physical examination, and 12-lead electrocardiogram (ECG).
* At screening, estimated GFR (by MDRD equation) should be ≥ 90 mL/min/1.73 m2.
Subject with Renal Impairment
In addition to the main inclusion criteria for all subjects, the following criteria must be met for all subjects with renal impairment enrolled in Groups 1, 2, 3, 4 and 6:
* Judged to be in stable condition and acceptable for study participation based upon the results of a medical history, physical examination, laboratory profile and ECG.
* Presence of chronic renal impairment as indicated by medical history and a screening estimated GFR (by MDRD equation) \< 90 mL/min/1.73 m2.
* Subjects with ESRD undergoing hemodialysis should have been receiving dialysis for at least 1 month.
Exclusion Criteria: - History of significant sensitivity to any drug.
* Pregnant or breastfeeding female.
* Recent (6-month) history of drug or alcohol abuse.
* Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab) or HIV antibodies (HIV Ab). Negative HIV status will be confirmed at Screening and the results will be maintained confidentially by the study site.
* Subjects on strict vegetarian diet.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02442258
Study Brief:
Protocol Section:
NCT02442258