NCT03054402

First in Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and to Explore Pharmacodynamics of BAY1834845

Randomized, Placebo-controlled, Double-blind Study to Investigate the Safety, Tolerability, Pharmacokinetics and to Explore Pharmacodynamics of Increasing Single Oral Doses of BAY1834845 Including Relative Bioavailability of a Liquid Versus a Solid Dosage in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study is a first in human study that will investigate the safety, tolerability and pharmacokinetics and explore the pharmacodynamics of ascending single doses of BAY1834845 using a placebo controlled, randomized, single center design.

Conditions

• Pelvic Inflammatory Disease

Interventions

Type	Name	Description
DRUG	BAY1834845	Escalating doses of BAY1834845 including comparison of solution and tablet in one dose group
DRUG	Placebo	Single dose of placebo

Timeline

• Start date: 2017-02-13
• Primary completion: 2017-11-30
• Completion: 2018-03-29
• First posted: 2017-02-15
• Last updated: 2019-03-27

Locations

1 site across 1 country: Germany