NCT02894385

Effect of Hepatic and Renal Impairment on the Pharmacokinetics, Safety and Tolerability of BAY1841788 (ODM-201)

A Phase I, Non-randomized, Open-label, Single-dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of BAY 1841788 (ODM-201) in Male Subjects With Hepatic Impairment, Renal Impairment and Normal Hepatic and Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 45 Years – 79 Years
• Healthy volunteers: Accepted

Summary

Evaluate the potential effect of hepatic or renal impairment on the pharmacokinetics, safety and tolerability of BAY 1841788 (ODM-201).

Detailed description

The study was closed after Part 1 because additional investigation in volunteers with moderate renal impairment in Part 2 was not deemed to be ethically or scientifically justified.

Conditions

• Pharmacokinetics
• Hepatic Insufficiency
• Renal Insufficiency

Interventions

Type	Name	Description
DRUG	BAY1841788	600 mg single dose, administered as 2 x 300 mg tablets on Day 00.

Timeline

• Start date: 2016-09-13
• Primary completion: 2017-04-10
• Completion: 2017-12-15
• First posted: 2016-09-09
• Last updated: 2019-01-07

Locations

2 sites across 1 country: Germany