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

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer

Criteria

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