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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03054402
Other study ID # 18384
Secondary ID 2016-002668-15
Status Completed
Phase Phase 1
First received
Last updated
Start date February 13, 2017
Est. completion date March 29, 2018

Study information

Verified date March 2019
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BAY1834845
Escalating doses of BAY1834845 including comparison of solution and tablet in one dose group
Placebo
Single dose of placebo

Locations

Country Name City State
Germany CRS Clinical Research Services Berlin GmbH Berlin

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

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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