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 @ 4:49 AM
Ignite Modification Date:
2025-12-25 @ 4:49 AM
NCT ID:
NCT02096718
Eligibility Criteria:
Inclusion criteria:
* Despite renal impairment (group 1 and 2) healthy males or females according to the investigators assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests.
* Glomerular filtration rate (GFR), estimated according to:
\-- MDRD (Modification of Diet in Renal Disease)-formula:
* eGFR (estimated Glomerular Filtration Rate) \[ml/min/1.73m²\]= 175 x Serum Creatinine-1.154 x age-0.203 (if male)
* eGFR\[ml/min/1.73m²\]= 175 x Serum Creatinine-1.154 x age-0.203 x 0.742 (if female)
* 30 to 59 mL/min for moderate renal impairment group 1
* 15 to 29 mL/min for severe renal impairment group 2
* = 90 mL/min for healthy volunteers group 3
* Age =18 and =79 years
Exclusion criteria:
* Any finding of the medical examination (including Blood Pressure (BP), Pulse Rate (PR) and Electrocardiogram (ECG)) deviating from normal and of clinical relevance, e.g. repeated measurement of systolic blood pressure \< 90 mmHg (millimeter of mercury) or \> 140 mmHg, diastolic blood pressure \< 50 mmHg or \> 90 mmHg, repeated measurement of pulse rate \< 45 bpm (beats per minute) or \> 90 bpm.
* Any evidence of a clinically relevant concomitant disease.
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, dermatological or hormonal disorders.
* Relevant gastrointestinal tract surgery (except appendectomy).
* Diseases of the central nervous system (such as epilepsy, seizures) or psychiatric disorders or neurological disorders.
* History of photosensitivity or recurrent rash.
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT02096718
Study Brief:
Protocol Section:
NCT02096718