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:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
NCT ID:
NCT01876316
Eligibility Criteria:
Inclusion Criteria:
\- 1) Subjects in Japan and Korea deemed healthy as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, or clinical laboratory determinations.
2\) Body Mass Index (BMI) of 17.6 to 26.4 kg/m2, BMI = weight (kg)/ \[height (m)\]2.
Exclusion Criteria:
* 1\) Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population.
2\) Any of the following on 12-lead ECG prior to study drug administration, confirmed by repeat.
* Heart rate ≤ 45 bpmmsec or Heart rate ≥ 100 bpmmsec
* PR ≥ 210 msec
* QRS ≥ 120 msec
* QT ≥ 500 msec
* QTcF: male ≥ 450 msec, female ≥470msec
* Iincomplete right bundle branch block
* Marked Sinus Arrhythmia
* Wondering pacemaker
* Atrial rhythm
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
35 Years
Study:
NCT01876316
Study Brief:
Protocol Section:
NCT01876316