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
2 other identifiers
interventional
64
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2018
CompletedFirst Posted
Study publicly available on registry
May 30, 2018
CompletedStudy Start
First participant enrolled
June 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 5, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedAugust 5, 2020
August 1, 2020
7 months
May 15, 2018
August 4, 2020
Conditions
Outcome Measures
Primary Outcomes (4)
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
Study Arms (2)
BAY1830839
EXPERIMENTALSingle Dose escalations
Placebo
PLACEBO COMPARATORMatching Placebo
Interventions
Eligibility Criteria
You may qualify if:
- Body mass index (BMI) : ≥18.5 and ≤30 kg/m\*2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (1)
CRS Clinical Research Services Berlin GmbH
Berlin, 13353, Germany
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2018
First Posted
May 30, 2018
Study Start
June 28, 2018
Primary Completion
February 5, 2019
Study Completion
August 1, 2019
Last Updated
August 5, 2020
Record last verified: 2020-08