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

Pelvic Inflammatory Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03054402
• Other study ID #: 18384
• Secondary ID: 2016-002668-15
• Status: Completed
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Pelvic Inflammatory Disease

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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