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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02212080

Enrollment

Registered

2014-08-08

Start date

2014-09-30

Completion date

2015-03-31

Last updated

2015-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical Trials, Phase I as Topic

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.

Interventions

DRUGBAY1214784

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026