Trial Condition(s):
Arthritis, Rheumatoid
BAY1830839: First in Man, single dose escalation, safety & tolerability and pharmacokinetics
Bayer Identifier:
19150
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations CRS Clinical Research Services Berlin GmbH Berlin, Germany, 13353 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
Randomized, placebo-controlled, double-blind study to investigate the safety, tolerability, and pharmacokinetics of increasing single oral doses of BAY1830839 in healthy male subjects
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Basic Science
Allocation:
Randomized
Blinding:
N/A
Assignment:
Sequential Assignment
Trial Arms:
2
Primary Outcome
- AUC of BAY1830839 in plasmaAUC: area under the plasma concentration vs time curve from zero to infinity after single dose.Timeframe: Day 1, 2, 3, 4, 6 ,7, 9, and 12
- Cmax of BAY1830839 in plasmamaximum observed drug concentration in plasma after single dose administrationTimeframe: Day 1, 2, 3, 4, 6 ,7, 9, and 12
- Frequency of treatment-emergent adverse eventsTimeframe: From first application of study intervention up to 30 days after end of treatment
- Severity of treatment-emergent adverse eventsTimeframe: From first application of study intervention up to 30 days after end of treatment
Additional Information
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