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 @ 5:28 PM
Ignite Modification Date:
2025-12-24 @ 5:28 PM
NCT ID:
NCT02857868
Eligibility Criteria:
Key Inclusion criteria:
* Body mass index of 18-36 kg/m2, with body weight 50 kg and no more than 120 kg
* Vital signs (after at least 3 minutes rest in the supine position) within the following ranges (inclusive):
* Oral body temperature between 35.0 °C - 37.5 °C (95.0-99.5°F)
* Systolic BP ≥90 mmHg and ≤140 mmHg
* Diastolic BP ≥60 mmHg and ≤90 mmHg for healthy subjects and 50-100 mmHg for subjects with impaired hepatic function (groups 2-4)
* Pulse Rate: ≥50 and ≤90 bpm for healthy subjects (group 1) and ≥50 and ≤100 bpm for subjects with impaired hepatic function (groups 2-4)
* Healthy subjects with no clinically significant abnormalities as determined by past medical history, physical examination, vital signs, ECG, and clinical laboratory test
* Subjects with Child-Pugh Clinical Assessment Score as calculated per the Child-Pugh classification
Key Exclusion Criteria:
* Presence of clinically significant ECG abnormalities or a family history or presence of prolonged QT-interval syndrome
* History of cardiac disease
* Sexually active males must use a condom during intercourse while taking the drug and for 7 days after stopping
* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs
* Administration of strong or moderate CYP3A4 inhibitors or inducers (including St John's wort) within 14 days prior to dosing
Other protocol-defined inclusion/exclusion criteria may apply.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02857868
Study Brief:
Protocol Section:
NCT02857868