Effect of Hepatic Impairment on LDE225..
NCT01764776 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33
Last updated 2020-12-19
Summary
This study is to evaluate the pharmacokinetics and safety of 800 mg of LDE225 in subjects with impaired hepatic function and healthy subjects with normal hepatic function.
Conditions
- Normal Hepatic Function
- Impaired Hepatic Function
Interventions
- DRUG
-
LDE225
LDE225
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis Pharmaceuticals · Novartis Pharmaceuticals
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2013-03-31
- Primary Completion
- 2015-03-31
- Completion
- 2015-03-31
Countries
- United States
- Belgium
- Bulgaria
- Germany
- Israel
Study Locations
More Related Trials
-
STUDY OF PF-06882961 IN PARTICIPANTS WITH AND WITHOUT VARYING DEGREES OF HEPATIC IMPAIREMENT
NCT04604496 ·Status: COMPLETED ·Phase: PHASE1
-
A Pharmacokinetic and Safety Study of E7080 in Subjects With Mild (10 mg), Moderate (10 mg), and Severe Hepatic Impairment (5 mg) and Normal Hepatic Function (10 mg)
NCT02421042 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Effect of Hepatic Impairment on JNJ-42847922 in Adult Participants
NCT04960124 ·Status: COMPLETED ·Phase: PHASE1
-
Effect Of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of PF-06865571 In Subjects With Hepatic Impairment and in Healthy Subjects
NCT04091061 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics of WCK 2349 In Patients With Hepatic Impairment
NCT02244827 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics of LCQ908 in Patients With Hepatic Impairment
NCT01594957 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetic Study of Icenticaftor in Participants With Hepatic Impairment
NCT04587622 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Learn About the Study Medicine (Called Lorlatinib) in People With Liver Dysfunction
NCT05224609 ·Status: COMPLETED ·Phase: PHASE1
-
Study on the Safety of Neladenoson Bialanate, How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Dug Given as a Single Oral Dose in Participants With Liver Impairment and Healthy Participants Matched for Age-, Gender-, and Weight
NCT04322253 ·Status: TERMINATED ·Phase: PHASE1
-
Evaluation Of Hepatic Impairment On AG-013736 Pharmacokinetics
NCT00692341 ·Status: COMPLETED ·Phase: PHASE1
-
HI Study to Assess and Compare the Pharmacokinetic Parameters of MD1003 in Hepatic Impaired Patients and Healthy Subjects
NCT04252417 ·Status: TERMINATED ·Phase: PHASE1
-
Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Mild and Moderate Hepatic Impairment Compared to Healthy Subjects
NCT03440424 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluate the Pharmacokinetics of CC-220 in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared With Healthy Subjects
NCT03824678 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluation of Renal Function Impairment on the Pharmacokinetics of LEE011
NCT02431481 ·Status: COMPLETED ·Phase: PHASE1
-
Effect of Moderate Hepatic Impairment on the Pharmacokinetics and Metabolism of a Single Dose of Licarbazepine
NCT00424671 ·Status: COMPLETED ·Phase: PHASE1
-
A STUDY TO COMPARE THE PHARMACOKINETICS OF PF-06835919 IN PARTICIPANTS WITH AND WITHOUT HEPATIC IMPAIRMENT
NCT04193436 ·Status: COMPLETED ·Phase: PHASE1
-
A Trial to Evaluate the Pharmacokinetics of ABL001 in Healthy and Hepatic Impaired Subjects
NCT02857868 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of TMC207 in Patients With Moderately Impaired Hepatic Function
NCT01012284 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics of Leritrelvir(RAY1216) in Participants With Hepatic Impairment
NCT06161259 ·Status: COMPLETED ·Phase: PHASE1
-
Impact of Hepatic Impairment on the Pharmacokinetics of Deferasirox.
NCT00432627 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Investigate the Effect of Mild and Moderate Hepatic Impairment on the Safety and Tolerability of Fezolinetant Compared to Participants With Normal Hepatic Function
NCT04482270 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of RAY1225 in Participants With Impaired Liver Function
NCT06577415 ·Status: RECRUITING ·Phase: PHASE1
-
A Study of TAK-279 in Adults With or Without Liver Damage
NCT05976321 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluate Severe Hepatic Impairment on Dacomitinib PK
NCT03865446 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess Pharmacokinetics of Preladenant in Participants With Chronic Hepatic Impairment (P06513)
NCT01465412 ·Status: COMPLETED ·Phase: PHASE1