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

Clinical Trials, Phase I as Topic Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02212080
• Other study ID #: 16924
• Secondary ID: 2014-000412-34
• Status: Completed
• Phase: Phase 1
• First received: August 7, 2014
• Last updated: March 10, 2015
• Start date: September 2014
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Clinical Trials, Phase I as Topic

Intervention

Drug:
• BAY1214784
Escalating doses of 5, 20, 60, 150, 300, 600, 1000 mg of BAY1214784; single dose administration; liquid dosage form
• Placebo
Dose 1, 2,3, 4, 5, 6 and 7 of respective placebos; single dose administration; liquid dosage form

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events		Up to 2 weeks after dosing	Yes
Primary	Severity of adverse events (mild, moderate, severe)		Up to 2 weeks after dosing	Yes

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