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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03540615

Enrollment

Registered

2018-05-30

Start date

2018-06-28

Completion date

2019-08-01

Last updated

2020-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Rheumatoid

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

Interventions

DRUGBAY1830839

Dose escalation in healthy male subjects

DRUGPlacebo

Matching placebo

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Dose escalation with safety assessment following each dose step.

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
AUC of BAY1830839 in plasma	Day 1, 2, 3, 4, 6 ,7, 9, and 12	AUC: area under the plasma concentration vs time curve from zero to infinity after single dose.
Cmax of BAY1830839 in plasma	Day 1, 2, 3, 4, 6 ,7, 9, and 12	maximum observed drug concentration in plasma after single dose administration
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	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026