NCT03493269

A Multiple Dose Study of BAY1834845 in Healthy Male Subjects and in Patients With Psoriasis

A Randomized, Double-blind, Placebo-controlled Study to Assess Safety, Tolerability, Pharmacokinetics and Exploratory Pharmacodynamics of Multiple Oral Doses of BAY1834845 in Healthy Male Subjects and in Female and Male Patients With Psoriasis Over an Extended Treatment Duration

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

To assess safety and tolerability of multiple oral doses of BAY1834845 in healthy male subjects (Part 1) and in patients with psoriasis (Part 2). To assess the pharmacokinetic (PK) properties of total BAY1834845 in plasma after oral multiple doses of BAY1834845 in healthy male subjects (Part 1) and patients with psoriasis (Part 2).

Conditions

• Healthy Volunteers
• Psoriasis

Interventions

Type	Name	Description
DRUG	BAY1834845	Orally administered.
OTHER	Matching Placebo	Orally administered.
DRUG	Midazolam	Part 1: Orally administered 1mg as a single dose.

Timeline

• Start date: 2018-04-16
• Primary completion: 2020-09-16
• Completion: 2021-02-05
• First posted: 2018-04-10
• Last updated: 2021-02-26

Locations

2 sites across 1 country: Germany