check_circleStudy Completed

Arthritis, Rheumatoid

Bayer Identifier:

19150

ClinicalTrials.gov Identifier:

NCT03540615

EudraCT Number:

2017-001496-23

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

Key Participants Requirements

Sex

Male

Age

18 - 50 Years
  • - Body mass index (BMI) : ≥18.5 and ≤30 kg/m*2
  • - 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
64
Trial Dates
June 2018 - August 2019
Phase
Phase 1
Could I Receive a placebo
Yes
Products
BAY1830839
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
CRS Clinical Research Services Berlin GmbHBerlin, 13353, Germany

Primary Outcome

  • AUC of BAY1830839 in plasma
    AUC: 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 plasma
    maximum observed drug concentration in plasma after single dose administration
    date_rangeTime Frame:
    Day 1, 2, 3, 4, 6 ,7, 9, and 12
  • Frequency of treatment-emergent adverse events
    date_rangeTime Frame:
    From first application of study intervention up to 30 days after end of treatment
  • Severity of treatment-emergent adverse events
    date_rangeTime Frame:
    From first application of study intervention up to 30 days after end of treatment

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

Additional Information

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