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

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

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

Study Overview

• Status: Completed
• Conditions: Arthritis, Rheumatoid
• Intervention / Treatment: Drug: Placebo; Drug: BAY1830839

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • CRS Clinical Research Services Berlin GMBH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Matching Placebo	Drug: Placebo; Matching placebo
Experimental: BAY1830839; Single Dose escalations	Drug: BAY1830839; Dose escalation in healthy male subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Frequency of treatment-emergent adverse events		From first application of study intervention up to 30 days after end of treatment
Severity of treatment-emergent adverse events		From first application of study intervention up to 30 days after end of treatment

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2018
• Primary Completion (Actual): February 5, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: May 15, 2018
• First Submitted That Met QC Criteria: May 29, 2018
• First Posted (Actual): May 30, 2018

Study Record Updates

• Last Update Posted (Actual): August 5, 2020
• Last Update Submitted That Met QC Criteria: August 4, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: 19150; 2017-001496-23 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No