Skip to main content
OpenTrials
Completed

NCT Number: NCT02212080

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Clinical Trials, Phase I as Topic

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Mönchengladbach, North Rhine-Westphalia, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BAY1214784

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Number of adverse events

    Time frame: Up to 2 weeks after dosing

  2. Severity of adverse events (mild, moderate, severe)

    Time frame: Up to 2 weeks after dosing

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 8, 2014
Registry last updated
Mar 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.