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

Phase 1

Completed

• Conditions: Arthritis, Rheumatoid
• Interventions: Drug: Placebo; Drug: BAY1830839

• Registration Number: NCT03540615
• Lead Sponsor: Bayer

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-05-15
• Study First Submitted QC: 2018-05-29
• Study First Posted: 2018-05-30
• Study Start: 2018-06-28
• Primary Completion: 2019-02-05
• Study Completion: 2019-08-01
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-04
• Last Update Posted: 2020-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 64

Inclusion Criteria

• Body mass index (BMI) : ≥18.5 and ≤30 kg/m*2

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching Placebo
BAY1830839	BAY1830839	Single Dose escalations

Primary Outcome Measures

Name	Time	Method
Severity of treatment-emergent adverse events	From first application of study intervention up to 30 days after end of treatment
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
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.

Trial Locations

Locations (1)

CRS Clinical Research Services Berlin GmbH; 🇩🇪 Berlin, Germany