One-center, Randomized, Placebo-controlled, Double Blind, Parallel Group Study to Investigate the Safety, Tolerability and Pharmacokinetics of Increasing Single Oral Doses (5-1000 mg, Solution) of BAY1214784 Including the Relative Bioavailability of BAY1214784 Administered as Solution With Two Different Concentrations in 56 Healthy Postmenopausal Women

Bayer0 sites48 target enrollmentSeptember 2014

ConditionsClinical Trials, Phase I as Topic

InterventionsBAY1214784 Placebo

DrugsBAY1214784 Placebo

Overview

Phase: Phase 1
Intervention: BAY1214784
Conditions: Clinical Trials, Phase I as Topic
Sponsor: Bayer
Enrollment: 48
Primary Endpoint: Severity of adverse events (mild, moderate, severe)
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

September 2014

End Date

March 2015

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility Criteria

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