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 @ 2:53 PM
Ignite Modification Date:
2025-12-24 @ 2:53 PM
NCT ID:
NCT01468259
Eligibility Criteria:
Inclusion Criteria:
* Informed Consent
* Male or Female between 18 and 79 years
* Female subject of childbearing potential not surgically sterile or min 2 years postmenopausal must use approved contraceptives
* BMI 20 to 40 kg per m2
* Refrain from exercise
* eGFR per protocol for condition
* Sufficient venous access
* Stable medication dosing 14 days prior to and during study
* Healthy control subjects must show good general health per protocol
* Subjects will be matched Healthy to Renal Impaired by demographics data
Exclusion Criteria:
* Inability to complete study
* Insufficient venous access
* Clinically significant illness within 4 weeks of study
* History of clinically unstable disease except renal impairment in those subjects
* Medical or surgical conditions that may inhibit absorption of IP
* Laboratory value or medical issue which may interfere with study data or be hazardous for the subject
* Medication that may interfere with drug absorption or elimination process 4 weeks prior to study
* Consumption of grapefruit products within 7 days prior and after study
* Dose changes of medications 14 days prior to and during study
* Active alcohol abuse or drug addiction
* Positive alcohol test at screening or after
* Excessive xanthine consumption
* Positive serology test Hepatitis B or Hepatitis C or HIV
* Excessive nicotine usage
* Positive urine screen for drugs of abuse without prescription
* Clinically relevant abnormal 12 lead ECG
* Donation of bood or plasma or platelets within 30 days of study
* Clinical trial with another agent within 30 days or 5 half lives whichever is longer
* Informed consent unavailable or withdrawn
* Any condition the investigator feels would interfere with study data or subjects health
* Employee or relative of study center or center staff or investigator
* Any condition that may increase risk for subject
* Clinically significant lab value
* Clinically significant acute or chronic disease other than renal impairment in those subjects that may interfere with data or health
* Medication dose change within 14 days of study
* Seated BP greater than 180 over 105
* Healthy subject with history of renal impairment
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT01468259
Study Brief:
Protocol Section:
NCT01468259