First in Human Study in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of BAY1214784

Phase 1CompletedNCT02212080

Bayer48 enrolled

Overview

This study is a first in human study that will investigate the safety, tolerability and pharmacokinetics of ascending single doses of BAY1214784 using a placebo controlled, randomized, single center design. In addition the bioavailability of two different liquid formulations will be compared.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Clinical Trials, Phase I as Topic

Interventions

BAY1214784DRUG

Escalating doses of 5, 20, 60, 150, 300, 600, 1000 mg of BAY1214784; single dose administration; liquid dosage form

PlaceboDRUG

Dose 1, 2,3, 4, 5, 6 and 7 of respective placebos; single dose administration; liquid dosage form

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy female subjects * Age 45 to 65 years * Body mass index (BMI) above/equal 20 and below/equal 30 kg/m2 * Postmenopausal state Exclusion Criteria: * Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal * Known or suspected malignant or benign tumors * Known or suspected liver disorders, relevant kidney diseases, known cardiovascular diseases, known metabolic disorders * Regular use of medicines

Locations (2)

Unnamed facility

Mönchengladbach, North Rhine-Westphalia, Germany

Unnamed facility

Erfurt, Thuringia, Germany

Outcomes

Primary Outcomes

Number of adverse events

Time frame: Up to 2 weeks after dosing

Severity of adverse events (mild, moderate, severe)

Time frame: Up to 2 weeks after dosing

Data from ClinicalTrials.gov

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