Trial Condition(s):

Clinical Trials, Phase I as Topic

First in human study to investigate the safety and tolerability, pharmacokinetics, itraconazole drug-drug-interaction and food effect of BAY1817080

Bayer Identifier:

18183

ClinicalTrials.gov Identifier:

NCT02817100

EudraCT Number:

2016-000253-12

Study Completed

Trial Purpose

This study is a first in human study that will investigate the safety, tolerability and pharmacokinetics of ascending single doses of BAY1817080 using a placebo controlled, randomized, single center design. In addition the influence of itraconazole and food on the pharmacokinetics of BAY1817080 will be investigated.

Inclusion Criteria
- Healthy male subjects
 - Age: 18 to 45 years (inclusive) 
 - Body mass index (BMI) : ≥18 and ≤30 kg/m²
 - Race: White
Exclusion Criteria
- Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
 - Relevant diseases within the last 4 weeks prior to the first drug administration
 - Existing chronic diseases requiring medication
 - Known or suspected malignant tumors or carcinoma in situ (including history of malignant tumors, with a status after treatment), known or suspected benign tumors of the liver and pituitary (including after treatment)
 - 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 any drugs which might influence the results of the trial within 14 days prior to administration or during the trial until follow-up including drugs which might affect the pharmacokinetics

Trial Summary

Enrollment Goal
88
Trial Dates
black-arrow
Phase
1
Could I receive a placebo?
Yes
Products
BAY1817080
Accepts Healthy Volunteers
Yes

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

CRS Clinical Research Services Berlin GmbH

Berlin, Germany, 13353

Status
Completed
 

Trial Design