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

Bayer64 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Arthritis, Rheumatoid

Interventions

BAY1830839DRUG

Dose escalation in healthy male subjects

PlaceboDRUG

Matching placebo

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

CRS Clinical Research Services Berlin GmbH

Berlin, Germany

Outcomes

Primary Outcomes

AUC of BAY1830839 in plasma

AUC: area under the plasma concentration vs time curve from zero to infinity after single dose.

Time 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

Time frame: Day 1, 2, 3, 4, 6 ,7, 9, and 12

Frequency of treatment-emergent adverse events

Time frame: From first application of study intervention up to 30 days after end of treatment

Severity of treatment-emergent adverse events

Time frame: From first application of study intervention up to 30 days after end of treatment

Data from ClinicalTrials.gov

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