Pelvic Inflammatory Disease
Conditions
Brief summary
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.
Interventions
DRUGBAY1834845
Escalating doses of BAY1834845 including comparison of solution and tablet in one dose group
DRUGPlacebo
Single dose of placebo
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of treatment-emergent adverse events (TEAEs) | Up to 25 days after last drug administration | 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. |
| Severity of treatment-emergent adverse events | Up to 25 days after last drug administration | The intensity of an AE is classified according to the following categories: * Mild * Moderate * Severe |
| Area under the plasma concentration vs. time curve (AUC) | Baseline to up to 14 days post drug administration | 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) |
| Maximum drug concentration in plasma after single dose administration (Cmax) | Baseline to up to 14 days post drug administration | Maximum drug concentration in plasma in mg/L after single dose administration of BAY1834845 |
Countries
Germany
Outcome results
None listed