NCT01950481

Effect of Hepatic Impairment on LDK378 Pharmacokinetics

A Phase I, Open Label, Multi-center, Single Dose Study to Evaluate the Pharmacokinetics of LDK378 in Subjects With Hepatic Impairment Compared to Subjects With Normal Hepatic Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Normal Hepatic Function
• Impaired Hepatic Function

Interventions

Type	Name	Description
DRUG	LDK378	Oral LDK378 750 mg once

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2013-09-25
• Last updated: 2020-12-19

Locations

5 sites across 1 country: United States