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Pharmacokinetics and Safety of Vilaprisan in Renal Impairment

NCT03411980 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2019-12-03

No results posted yet for this study

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.

Conditions

  • Uterine Fibroids
  • Endometriosis

Interventions

DRUG

Vilaprisan (BAY1002670)

Single oral dose (1 x 2 mg immediate-release, film-coated tablet)

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-02
Primary Completion
2018-10-10
Completion
2019-02-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03411980 on ClinicalTrials.gov