First in Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and to Explore Pharmacodynamics of BAY1834845

Bayer70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Pelvic Inflammatory Disease

Interventions

BAY1834845DRUG

Escalating doses of BAY1834845 including comparison of solution and tablet in one dose group

PlaceboDRUG

Single dose of placebo

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

CRS Clinical Research Services Berlin GmbH

Berlin, Germany

Outcomes

Primary Outcomes

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.

Time frame: Up to 25 days after last drug administration

Severity of treatment-emergent adverse events

The intensity of an AE is classified according to the following categories: * Mild * Moderate * Severe

Time frame: 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)

Time frame: 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 BAY1834845

Time frame: Baseline to up to 14 days post drug administration

Data from ClinicalTrials.gov

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