check_circleStudy Completed
Arthritis, Rheumatoid
Bayer Identifier:
19150
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
BAY1830839: First in Man, single dose escalation, safety & tolerability and pharmacokinetics
Trial purpose
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
• 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
Key Participants Requirements
Sex
MaleAge
18 - 50 YearsTrial summary
Enrollment Goal
64Trial Dates
June 2018 - August 2019Phase
Phase 1Could I Receive a placebo
YesProducts
BAY1830839Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | CRS Clinical Research Services Berlin GmbH | Berlin, 13353, Germany |
Primary Outcome
- AUC of BAY1830839 in plasmaAUC: area under the plasma concentration vs time curve from zero to infinity after single dose.date_rangeTime Frame:Day 1, 2, 3, 4, 6 ,7, 9, and 12
- Cmax of BAY1830839 in plasmamaximum observed drug concentration in plasma after single dose administrationdate_rangeTime Frame:Day 1, 2, 3, 4, 6 ,7, 9, and 12
- Frequency of treatment-emergent adverse eventsdate_rangeTime Frame:From first application of study intervention up to 30 days after end of treatment
- Severity of treatment-emergent adverse eventsdate_rangeTime Frame:From first application of study intervention up to 30 days after end of treatment
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
Basic ScienceAllocation
RandomizedBlinding
N/AAssignment
Sequential AssignmentTrial Arms
2