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 @ 2:42 PM
Ignite Modification Date:
2025-12-24 @ 2:42 PM
NCT ID:
NCT02014259
Eligibility Criteria:
Inclusion Criteria:
* Male or female aged 18-85 years (both inclusive) at the time of signing inform consent
* Subject with normal renal function or renal impairment (mild, moderate, severe or end-stage renal disease requiring dialysis)
* For subject with normal renal function: good general health (as judged by the investigator)
* Body mass index (BMI) 18.5-40.0 kg/m\^2 (both inclusive)
Exclusion Criteria:
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods
* History of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease
* Uncontrolled hypertension (defined as systolic blood pressure above or equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg)
* Any blood draw or donation of blood or plasma in excess of 400 mL within the 3 months preceding the screening visit (Visit 2)
* History of significant drug abuse, or a positive drug test at the screening visit (Visit 2)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT02014259
Study Brief:
Protocol Section:
NCT02014259