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

• Status: Completed
• Trial end date: 2018-03-29
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer

Criteria

Inclusion Criteria:

• Healthy male subject

• Age: 18 to 50 years (inclusive) at the first screening visit

• Body mass index (BMI) : 18.5 ≤ BMI ≤ 30 kg/m²

Exclusion Criteria:

• Clinically relevant findings in the physical examination

• Relevant diseases within the last 4 weeks prior to the first study drug administration

• Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal

• Use of systemic or topical medicines or substances which oppose the study objectives or which might influence them within 4 weeks before first study drug administration