NCT03411980

Pharmacokinetics and Safety of Vilaprisan in Renal Impairment

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Uterine Fibroids
• Endometriosis

Interventions

Type	Name	Description
DRUG	Vilaprisan (BAY1002670)	Single oral dose (1 x 2 mg immediate-release, film-coated tablet)

Timeline

• Start date: 2018-02-02
• Primary completion: 2018-10-10
• Completion: 2019-02-06
• First posted: 2018-01-26
• Last updated: 2019-12-03

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study