Trial Condition(s):

Clinical Trials, Phase I as Topic

BAY 1902607: Single dose escalation, safety and tolerability, pharmacokinetics, bioavailability, food effect

Bayer Identifier:

18922

ClinicalTrials.gov Identifier:

NCT03212586

EudraCT Number:

2017-000978-11

Study Completed

Trial Purpose

This study is a first-in-man study that will investigate the safety, tolerability and pharmacokinetics of ascending single doses of BAY1902607 using a placebo controlled, randomized, single center design. In addition the influence of food on the pharmacokinetics of BAY1902607 and the bioavailability between different pharmaceutical formulations will be investigated

Inclusion Criteria
- Healthy male subjects.
 - Age: 18 to 45 years (inclusive) .
 - Body mass index (BMI) : ≥18 and ≤30 kg/m^2.
 - Race: White.
Exclusion Criteria
- Any findings from the medical examination (including medical history, physical examination, vital signs, laboratory tests and ECG) deviating from normal and deemed by the investigator to be of clinical relevance.
- Relevant diseases within the 4 weeks before the first drug administration.
- Febrile illness within the week before the first taste test is conducted.

Trial Summary

Enrollment Goal
72
Trial Dates
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Phase
1
Could I receive a placebo?
Yes
Products
BAY1902607
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