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

Phase 1

Completed

• Conditions: Clinical Trials, Phase I as Topic
• Interventions: Drug: Placebo; Drug: BAY1214784

• Registration Number: NCT02212080
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-07
• Study First Submitted QC: 2014-08-07
• Study First Posted: 2014-08-08
• Study Start: 2014-09
• Status Verified: 2015-03
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-03-10
• Last Update Posted: 2015-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo Dose 1 to 7 of BAY1214784
BAY1214784	BAY1214784	Dose 1 to 7 of BAY1214784

Primary Outcome Measures

Name	Time	Method
Severity of adverse events (mild, moderate, severe)	Up to 2 weeks after dosing
Number of adverse events	Up to 2 weeks after dosing