Trial Condition(s):

Pelvic Inflammatory Disease

First in human study to investigate the safety, tolerability, pharmacokinetics and to explore pharmacodynamics of BAY1834845

Bayer Identifier:

18384

ClinicalTrials.gov Identifier:

NCT03054402

EudraCT Number:

2016-002668-15

EU CT Number:

Not Available

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
70
Trial Dates
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Phase
1
Could I receive a placebo?
Yes
Products
BAY1834845
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

CRS Clinical Research Services Berlin GmbH

Berlin, Germany, 13353

Status
Completed

Trial Design