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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-28

Study Completion Date

2019-08-01

Brief Summary

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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

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Detailed Description

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Conditions

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Arthritis, Rheumatoid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Dose escalation with safety assessment following each dose step.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BAY1830839

Single Dose escalations

Group Type EXPERIMENTAL

BAY1830839

Intervention Type DRUG

Dose escalation in healthy male subjects

Placebo

Matching Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo

Interventions

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BAY1830839

Dose escalation in healthy male subjects

Intervention Type DRUG

Placebo

Matching placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes