Effect of Hepatic Impairment on LDK378 Pharmacokinetics

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Pharmacokinetics and safety of 750 mg of LDK378 given once orally in subjects with impaired hepatic function and healthy subjects with normal hepatic function.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Ceritinib

Criteria

Inclusion Criteria (all groups):

• Male Subjects between 18-70 years of age

• Female subjects between 18-70 years of age who are postmenopausal or sterile

• Body Mass Index (BMI) of 18.0- 36.0 kg/m2, with body weight ≥ 50 kg.

Inclusion (group mild, moderate and severe hepatic impairment):

• Subjects with confirmed cirrhosis

Exclusion Criteria (all groups):

• impaired cardiac function

• concurrent severe and/or uncontrolled medical conditions

Exclusion Criteria (moderate, mild and severe groups):

• Clinical evidence of severe ascites

• Use of PPIs within 10 days prior to 2 days after LDK378 dosing