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 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 12:24 AM
NCT ID:
NCT00736658
Eligibility Criteria:
Inclusion Criteria:
* Healthy Japanese males or females young (≥20 to ≤45 years inclusive) or elderly (≥65 to ≤80 years inclusive). Female subjects must be surgically sterile or post-menopausal.
* Body Mass Index (BMI) of ≥19 to ≤ 27 kg/m2 and weight of ≥45 to ≤90 kg
* Clinically normal physical findings including heart rate \> 45 bpm and laboratory values and normal resting ECG
Exclusion Criteria:
* History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study as judged by the investigator
* A family history of short or long QT syndrome (SQTS) or sudden cardiac death (SCD) amongst first degree relatives
* Subjects with orthostatic hypotension defined as a decrease of ≥ 25mmHg systolic blood pressure and/or a decrease of ≥15mmHg diastolic blood pressure within 5 minutes when going from a supine to standing position
* Clinically significant illness or clinically relevant trauma within 2 weeks prior to the administration of the investigational product as judged by the investigator
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
80 Years
Study:
NCT00736658
Study Brief:
Protocol Section:
NCT00736658