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:
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 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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations CRS Clinical Research Services Berlin GmbH Berlin, Germany, 13353 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
Randomized, placebo-controlled, double-blind study to investigate the safety, tolerability, pharmacokinetics and to explore pharmacodynamics of increasing single oral doses of BAY1834845 including relative bioavailability of a liquid versus a solid dosage in healthy male volunteers
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 events (TEAEs)AEs are considered to be treatment-emergent if they have started or worsened after first application of study medication up to 30 days after end of treatment with study medication.Timeframe: Up to 25 days after last drug administration
- Severity of treatment-emergent adverse eventsThe intensity of an AE is classified according to the following categories: - Mild - Moderate - SevereTimeframe: Up to 25 days after last drug administration
- Area under the plasma concentration vs. time curve (AUC)AUC from zero to infinity after single dose if possible or from time 0 to the last data point above lower limit of quantification (AUC (0-tlast)Timeframe: Baseline to up to 14 days post drug administration
- Maximum drug concentration in plasma after single dose administration (Cmax)Maximum drug concentration in plasma in mg/L after single dose administration of BAY1834845Timeframe: Baseline to up to 14 days post drug administration
Additional Information
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