NCT03092999

Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of BAY1002670 (Vilaprisan)

Investigation of Pharmacokinetics, Safety, and Tolerability of Vilaprisan (BAY1002670) in Subjects With Hepatic Impairment (Classified as Child-Pugh A or B) Compared to Sex, Age, and Weight-matched Healthy Subjects Following a Single Oral Dose

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

Summary

Evaluate the potential effect of hepatic impairment on the pharmacokinetics, safety and tolerability of BAY1002670 (vilaprisan)

Conditions

• Leiomyoma

Interventions

Type	Name	Description
DRUG	Vilaprisan (BAY1002670)	2 mg tablet, single dose, oral administration

Timeline

• Start date: 2017-03-28
• Primary completion: 2017-07-17
• Completion: 2017-07-17
• First posted: 2017-03-28
• Last updated: 2017-08-18

Locations

2 sites across 1 country: Germany