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

Phase 1

Completed

• Conditions: Pelvic Inflammatory Disease
• Interventions: Drug: Placebo; Drug: BAY1834845

• Registration Number: NCT03054402
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-02-13
• Study First Submitted: 2017-02-13
• Study First Submitted QC: 2017-02-13
• Study First Posted: 2017-02-15
• Primary Completion: 2017-11-30
• Study Completion: 2018-03-29
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-26
• Last Update Posted: 2019-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 70

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subjects will receive a single dose of placebo in the morning of the PK profile day
Dose escalation/BAY1834845	BAY1834845	Subjects will receive a single dose of BAY1834845 in the morning of the PK profile day

Primary Outcome Measures

Name	Time	Method
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
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)
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.

Trial Locations

Locations (1)

CRS Clinical Research Services Berlin GmbH; 🇩🇪 Berlin, Germany