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 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 12:19 AM
NCT ID:
NCT02390258
Eligibility Criteria:
Inclusion Criteria:
* For Parts 1 and 3 healthy, male subjects aged 18 to 45 years, inclusive. For Part 2 healthy, male and female subjects aged 45 to 65 years, inclusive.
* Females must be of non-childbearing potential
Exclusion Criteria:
* Subject has a known heart disease.
* Subject has any of QTcF \> 450 msec, PR ≥ 210 msec or QRS ≥ 120 msec at screening (determined from median of three readings).
* For Part 1 only: subject has resting heart rate outside of the range 45 to 80 beats per minute (bpm) at screening (determined from median of three readings).
* Subject has any other condition which, in the investigator's opinion will interfere with the trial.
* Subject has a systolic blood pressure (BP) \<80 or \>160 mmHg at screening or a diastolic BP \>90 or \<45 mmHg at screening.
* Subject has a clinically significant abnormal laboratory test result at screening.
* Female subject who is pregnant or breast feeding and female subjects of childbearing potential.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02390258
Study Brief:
Protocol Section:
NCT02390258