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Keep this study
Lead
Novartis Pharmaceuticals
Age
18–75
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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
You may not be if
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
