Back to resultsBAY1830839: First in Man, Single Dose Escalation, Safety & Tolerability and Pharmacokinetics
Primary Purpose
Arthritis, Rheumatoid
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
BAY1830839
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Arthritis, Rheumatoid
Eligibility Criteria
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
Sites / Locations
- CRS Clinical Research Services Berlin GmbH
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
BAY1830839
Placebo
Arm Description
Single Dose escalations
Matching Placebo
Outcomes
Primary Outcome Measures
AUC of BAY1830839 in plasma
AUC: area under the plasma concentration vs time curve from zero to infinity after single dose.
Cmax of BAY1830839 in plasma
maximum observed drug concentration in plasma after single dose administration
Frequency of treatment-emergent adverse events
Severity of treatment-emergent adverse events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03540615
Brief Title
BAY1830839: First in Man, Single Dose Escalation, Safety & Tolerability and Pharmacokinetics
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
June 28, 2018 (Actual)
Primary Completion Date
February 5, 2019 (Actual)
Study Completion Date
August 1, 2019 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Dose escalation with safety assessment following each dose step.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BAY1830839
Arm Type
Experimental
Arm Description
Single Dose escalations
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching Placebo
Intervention Type
Drug
Intervention Name(s)
BAY1830839
Intervention Description
Dose escalation in healthy male subjects
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo
Primary Outcome Measure Information:
Title
AUC of BAY1830839 in plasma
Description
AUC: area under the plasma concentration vs time curve from zero to infinity after single dose.
Time Frame
Day 1, 2, 3, 4, 6 ,7, 9, and 12
Title
Cmax of BAY1830839 in plasma
Description
maximum observed drug concentration in plasma after single dose administration
Time Frame
Day 1, 2, 3, 4, 6 ,7, 9, and 12
Title
Frequency of treatment-emergent adverse events
Time Frame
From first application of study intervention up to 30 days after end of treatment
Title
Severity of treatment-emergent adverse events
Time Frame
From first application of study intervention up to 30 days after end of treatment
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
CRS Clinical Research Services Berlin GmbH
City
Berlin
ZIP/Postal Code
13353
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Learn more about this trial
BAY1830839: First in Man, Single Dose Escalation, Safety & Tolerability and Pharmacokinetics
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