BAY1830839: First in Man, Single Dose Escalation, Safety & Tolerability and Pharmacokinetics

Arthritis, Rheumatoid Clinical Trial

Official title:

Randomized, Placebo-controlled, Double-blind Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Increasing Single Oral Doses of BAY1830839 in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03540615
• Other study ID #: 19150
• Secondary ID: 2017-001496-23
• Status: Completed
• Phase: Phase 1
• Start date: June 28, 2018
• Est. completion date: August 1, 2019

Study information

• Verified date: August 2020
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objectives of this study are to investigate

• the safety and tolerability of increasing single oral doses of BAY 1830839 versus placebo under fasted conditions

• the pharmacokinetics after single ascending oral doses of BAY 1830839 under fasted conditions

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: August 1, 2019
• Est. primary completion date: February 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Body mass index (BMI) : =18.5 and =30 kg/m*2

Exclusion Criteria:

• Relevant diseases within the last 4 weeks prior to the first study drug administration

• Febrile illness within 4 weeks before the first study drug administration

• Known hypersensitivity to the study drugs or components of the preparations

• Clinically relevant findings in the physical examination

Related Conditions & MeSH terms

• Arthritis, Rheumatoid

Intervention

Drug:
• BAY1830839
Dose escalation in healthy male subjects
• Placebo
Matching 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	AUC of BAY1830839 in plasma	AUC: area under the plasma concentration vs time curve from zero to infinity after single dose.	Day 1, 2, 3, 4, 6 ,7, 9, and 12
Primary	Cmax of BAY1830839 in plasma	maximum observed drug concentration in plasma after single dose administration	Day 1, 2, 3, 4, 6 ,7, 9, and 12
Primary	Frequency of treatment-emergent adverse events		From first application of study intervention up to 30 days after end of treatment
Primary	Severity of treatment-emergent adverse events		From first application of study intervention up to 30 days after end of treatment

External Links

•   Click here to find information about studies related to Bayer Healthcare products conducted in Europe