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

Bayer

Status and phase: Completed; Phase 1

Conditions: Clinical Trials, Phase I as Topic

Treatments: Drug: Placebo; Drug: BAY1214784

Study type: Interventional

Funder types: Industry

Identifiers

NCT02212080

2014-000412-34 (EudraCT Number)

16924

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

BAY1214784

Experimental group

Description:

Dose 1 to 7 of BAY1214784

Treatment:

Drug: BAY1214784

Placebo

Placebo Comparator group

Description:

Placebo Dose 1 to 7 of BAY1214784

Treatment:

Drug: Placebo