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BAY1830839: First in Man, Single Dose Escalation, Safety & Tolerability and Pharmacokinetics

NCT03540615 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2020-08-05

No results posted yet for this study

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

Conditions

  • Arthritis, Rheumatoid

Interventions

DRUG

BAY1830839

Dose escalation in healthy male subjects

DRUG

Placebo

Matching placebo

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-28
Primary Completion
2019-02-05
Completion
2019-08-01

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03540615 on ClinicalTrials.gov