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:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations CRS Clinical Research Services Berlin GmbH Berlin, Germany, 13353 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Trial Design
Randomized, placebo-controlled, double-blind, parallel group study to investigate the safety, tolerability and pharmacokinetics of increasing single oral doses (10 - 1500 mg, tablets) of BAY1817080 including the effect of food and itraconazole on the relative bioavailability of BAY1817080 in healthy men
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Basic Science
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Frequency of treatment-emergent adverse eventsTimeframe: Up to 4 months
- Severity of treatment-emergent adverse eventsTimeframe: Up to 4 months
Additional Information
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