NCT02212080

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 8, 2014

Completed
24 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 11, 2015

Status Verified

March 1, 2015

Enrollment Period

6 months

First QC Date

August 7, 2014

Last Update Submit

March 10, 2015

Conditions

Clinical Trials, Phase I as Topic

Outcome Measures

Primary Outcomes (2)

  • Number of adverse events

    Up to 2 weeks after dosing

  • Severity of adverse events (mild, moderate, severe)

    Up to 2 weeks after dosing

Study Arms (2)

BAY1214784

EXPERIMENTAL

Dose 1 to 7 of BAY1214784

Drug: BAY1214784

Placebo

PLACEBO COMPARATOR

Placebo Dose 1 to 7 of BAY1214784

Drug: Placebo

Interventions

BAY1214784DRUG

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

BAY1214784
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy female subjects
  • Age 45 to 65 years
  • Body mass index (BMI) above/equal 20 and below/equal 30 kg/m2
  • Postmenopausal state

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Mönchengladbach, North Rhine-Westphalia, 41061, Germany

Location

Unknown Facility

Erfurt, Thuringia, 99084, Germany

Location

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2014

First Posted

August 8, 2014

Study Start

September 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

March 11, 2015

Record last verified: 2015-03

Locations

DE(2)