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 @ 12:22 PM
Ignite Modification Date:
2025-12-24 @ 12:22 PM
NCT ID:
NCT01579461
Eligibility Criteria:
Inclusion Criteria:
* Body Mass Index more than or equal to 18.0 and less than 32.0 kg/m2 (men and women)
* Subject is genotyped as an extensive metabolizer for CYP2D6
* For subjects with mild/moderate hepatic impairment: Hepatic dysfunction scored as mild impairment ((between 5-6 in the Child-Pugh's classification) and moderate impairment (between 7-9 in the Child-Pugh's classification)
* Healthy subject with normal hepatic function
Exclusion Criteria:
* Known or suspected hypersensitivity to mirabegron or any components of the formulations used
* A marked prolongation at screening of QT/QTC interval demonstrated by a mean QTcF interval \>450 ms for male subjects and a mean QTcF interval \>470 ms for female subjects (based on 3 ECGs)
* Abnormal pulse rate and/or blood pressure measurements at the pre-study visit taken in triplicate by means of an automatic device, after subject has been resting in supine position for 5 min: •Pulse rate \<40 or \>90 bpm; Mean systolic blood pressure \<90 or \>160 mmHg; Mean diastolic blood pressure \<40 or \>95 mmHg
* Healthy subjects: use of any prescribed or OTC drugs (except paracetamol, with a maximum of 3g/day) in the 2 weeks prior to admission to the clinical unit
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01579461
Study Brief:
Protocol Section:
NCT01579461