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Pharmacokinetics and Safety of Vilaprisan in Renal Impairment

Endometriosis Clinical Trial

Official title:
An Open-label, Single-dose Study to Evaluate the Pharmacokinetics and Safety of Vilaprisan in Subjects With Decreased Renal Function in Comparison With Matched Subjects With Normal Renal Function

Clinical Trial Summary

The purpose of the study is to evaluate the pharmacokinetics of vilaprisan in subjects with moderate to severe renal impairment compared with matched subjects with normal renal function.

Clinical Trial Description

This is a multiple-center, open-label, non-randomized, single-dose study in 3 parallel groups of subjects with moderately or severely impaired renal function or normal renal function matched with regard to sex, age, race and weight. PK blood and urine sampling for determination of vilaprisan concentrations in plasma and urine, respectively, will be preformed at pre-defined time points up to 14 days post-dose. Safety and tolerability will be assessed through adverse events, clinical laboratory tests, vital signs, 12-lead electrocardiograms and physical examinations. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03411980
Study type Interventional
Source Bayer
Contact
Status Completed
Phase Phase 1
Start date February 2, 2018
Completion date February 6, 2019
View Details
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