NCT02399202

A Phase I Study of Osilodrostat (LCI699) in Healthy Volunteers and Subjects With Impaired Renal Function

A Phase I, Open-label, Multi-center, Single Dose, Parallel Group Study to Evaluate the Pharmacokinetics and Safety of LCI699 in Subjects With Varying Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

To characterize the pharmacokinetics of LCI699 following a single oral dose in adult subjects with various degrees of impaired renal function.

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	osilodrostat

Timeline

• Start date: 2015-11-06
• Primary completion: 2016-03-21
• Completion: 2016-03-21
• First posted: 2015-03-26
• Last updated: 2020-12-19

Locations

2 sites across 2 countries: Bulgaria, Germany