Pharmacokinetics of LCQ908 in Patients With Hepatic Impairment
Completed · Phase 1
Conditions studied: Hepatic Impairment
In brief
This study will compare the pharmacokinetics of LCQ908 in subjects with varying degrees of hepatic impairment to healthy subjects.
Key facts
- Study ID
- NCT01594957
- Run by
- Novartis Pharmaceuticals
- People needed
- 53
- Starts
- 2012-04-01
- Expected to finish
- 2013-04-01
- Last updated by the study team
- 2020-12-19
Who can join
Age: any. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Individuals with hepatic impairment only
- Hepatic impairment evidenced by a Child-Pugh score
- Mild hepatic impairment defined Child-Pugh Class A (5-6 points)
- Moderate hepatic impairment defined Child-Pugh Class B (7-9 points)
- Severe hepatic impairment defined Child-Pugh Class C (10-15 points).
- Healthy subjects only
- Good health determined.
You may not qualify if…
- All Individuals
- A past medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome.
- Female subjects must be of non child bearing potential or use an effective method of contraception.
- Individuals with hepatic impairment
- History of drug or alcohol abuse within 3 months prior to dosing.
- History or presence of significant uncontrolled disease of any major organ class.
- Any surgical or medical condition other than hepatic impairment which might alter the drug metabolism.
- Healthy subjects
- History or presence of significant uncontrolled disease of any major organ class.
- Any surgical or medical condition other than hepatic impairment which might alter the drug metabolism.
- History or presence of hepatitis B or C and/or positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result at screening.
- Other protocol-defined inclusion/exclusion criteria may apply.
Where it is running
- Novartis Investigative Site — Miami, Florida, United States
- Novartis Investigative Site — Orlando, Florida, United States
Full record on ClinicalTrials.gov
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