Pelvic Inflammatory Disease Clinical Trial
Official title:
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
Verified date | March 2019 |
Source | Bayer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | March 29, 2018 |
Est. primary completion date | November 30, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 50 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Germany | CRS Clinical Research Services Berlin GmbH | Berlin |
Lead Sponsor | Collaborator |
---|---|
Bayer |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Up to 25 days after last drug administration | |
Primary | Severity of treatment-emergent adverse events | The intensity of an AE is classified according to the following categories: Mild Moderate Severe |
Up to 25 days after last drug administration | |
Primary | 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) | Baseline to up to 14 days post drug administration | |
Primary | Maximum drug concentration in plasma after single dose administration (Cmax) | Maximum drug concentration in plasma in mg/L after single dose administration of BAY1834845 | Baseline to up to 14 days post drug administration |
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