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

Primary Purpose

Pelvic Inflammatory Disease

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

BAY1834845

Placebo

About this trial

This is an interventional basic science trial for Pelvic Inflammatory Disease

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

CRS Clinical Research Services Berlin GmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dose escalation/BAY1834845

Placebo

Arm Description

Subjects will receive a single dose of BAY1834845 in the morning of the PK profile day

Subjects will receive a single dose of placebo in the morning of the PK profile day

Outcomes

Primary Outcome Measures

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.

Severity of treatment-emergent adverse events

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

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)

Maximum drug concentration in plasma after single dose administration (Cmax)

Maximum drug concentration in plasma in mg/L after single dose administration of BAY1834845

Secondary Outcome Measures

Full Information

NCT ID

NCT03054402

First Posted

February 13, 2017

Last Updated

March 26, 2019

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT03054402

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

February 13, 2017 (Actual)

Primary Completion Date

November 30, 2017 (Actual)

Study Completion Date

March 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pelvic Inflammatory Disease

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dose escalation/BAY1834845

Arm Type

Experimental

Arm Description

Subjects will receive a single dose of BAY1834845 in the morning of the PK profile day

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Subjects will receive a single dose of placebo in the morning of the PK profile day

Intervention Type

Drug

Intervention Name(s)

BAY1834845

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Single dose of placebo

Primary Outcome Measure Information:

Title

Frequency of treatment-emergent adverse events (TEAEs)

Description

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

Title

Severity of treatment-emergent adverse events

Description

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

Title

Area under the plasma concentration vs. time curve (AUC)

Description

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

Title

Maximum drug concentration in plasma after single dose administration (Cmax)

Description

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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

Facility Name

CRS Clinical Research Services Berlin GmbH

City

Berlin

ZIP/Postal Code

13353

Country

Germany

12. IPD Sharing Statement

Links:

URL

https://clinicaltrials.bayer.com/

Description

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

Learn more about this trial

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

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