Pharmacokinetics of LCQ908 in Patients With Hepatic Impairment
NCT ID: NCT01594957
Last Updated: 2020-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
53 participants
INTERVENTIONAL
2012-04-30
2013-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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LCQ908 (mild hepatic impairment plus healthy volunteers)
Healthy subjects will be matched pair-wise by, sex, race, age (±10 years) and weight (±20%) to subjects with mild hepatic impairment and will receive a single dose of LCQ908.
LCQ908
Participants will receive a single oral dose of LCQ908
LCQ908 (moderate hepatic impairment plus healthy volunteers)
Healthy subjects will be matched pair-wise by, sex, race, age (±10 years) and weight (±20%) to subjects with moderate hepatic impairment and will receive a single dose of LCQ908.
LCQ908
Participants will receive a single oral dose of LCQ908
LCQ908 (severe hepatic impairment plus healthy volunteers)
Healthy subjects will be matched pair-wise by, sex, race, age (±10 years) and weight (±20%) to subjects with severe hepatic impairment and will receive a single dose of LCQ908.
LCQ908
Participants will receive a single oral dose of LCQ908
Interventions
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LCQ908
Participants will receive a single oral dose of LCQ908
Eligibility Criteria
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Inclusion Criteria
• 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.
Exclusion Criteria
* 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.
ALL
Yes
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Miami, Florida, United States
Novartis Investigative Site
Orlando, Florida, United States
Countries
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References
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Hirano M, Meyers D, Golla G, Pal P, Pinot P, Lin T, Majumdar T, Rebello S, Sunkara G, Chen J. Effect of Hepatic Impairment on the Pharmacokinetics of Pradigastat, a Diacylglycerol Acyltransferase 1 (DGAT1) Inhibitor. Clin Pharmacokinet. 2015 Jul;54(7):761-70. doi: 10.1007/s40262-015-0235-9.
Related Links
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Results for CCLCQ908B2101 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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CLCQ908B2101
Identifier Type: -
Identifier Source: org_study_id