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

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

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 Overview

• Status: Completed
• Conditions: Pelvic Inflammatory Disease
• Intervention / Treatment: Drug: Placebo; Drug: BAY1834845

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • CRS Clinical Research Services Berlin GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose escalation/BAY1834845; Subjects will receive a single dose of BAY1834845 in the morning of the PK profile day	Drug: BAY1834845; Escalating doses of BAY1834845 including comparison of solution and tablet in one dose group
Placebo Comparator: Placebo; Subjects will receive a single dose of placebo in the morning of the PK profile day	Drug: Placebo; Single dose of placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find results for studies related to Bayer products.

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2017
• Primary Completion (Actual): November 30, 2017
• Study Completion (Actual): March 29, 2018

Study Registration Dates

• First Submitted: February 13, 2017
• First Submitted That Met QC Criteria: February 13, 2017
• First Posted (Actual): February 15, 2017

Study Record Updates

• Last Update Posted (Actual): March 27, 2019
• Last Update Submitted That Met QC Criteria: March 26, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Adnexal Diseases; Pelvic Inflammatory Disease; Pelvic Infection
• Other Study ID Numbers: 18384; 2016-002668-15 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No