check_circleStudy Completed
Pelvic Inflammatory Disease
Bayer Identifier:
18384
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
First in human study to investigate the safety, tolerability, pharmacokinetics and to explore pharmacodynamics of BAY1834845
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.
Key Participants Requirements
Sex
MaleAge
18 - 50 YearsTrial summary
Enrollment Goal
70Trial Dates
February 2017 - March 2018Phase
Phase 1Could I Receive a placebo
YesProducts
BAY1834845Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | CRS Clinical Research Services Berlin GmbH | Berlin, 13353, Germany |
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.date_rangeTime Frame:Up to 25 days after last drug administrationenhanced_encryptionYesSafety Issue:
- Severity of treatment-emergent adverse eventsThe intensity of an AE is classified according to the following categories: - Mild - Moderate - Severedate_rangeTime Frame:Up to 25 days after last drug administrationenhanced_encryptionYesSafety Issue:
- 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)date_rangeTime Frame:Baseline to up to 14 days post drug administrationenhanced_encryptionNoSafety Issue:
- Maximum drug concentration in plasma after single dose administration (Cmax)Maximum drug concentration in plasma in mg/L after single dose administration of BAY1834845date_rangeTime Frame:Baseline to up to 14 days post drug administrationenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
Basic ScienceAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2