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Study to Investigate the Natriuretic Effects, Safety, Tolerability and Pharmacokinetics of BAY94-8862

NCT01473108 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2022-02-09

No results posted yet for this study

Summary

Pharmacodynamics, pharmacokinetics, safety, and tolerability will be investigated in this single dose study. In 5 treatment groups, different dosages of BAY94-8862 will be given in healthy male subjects.

Conditions

  • Clinical Pharmacology

Interventions

DRUG

Finerenone (BAY 94-8862) PEG solution

2.5, 5, 10, 20 mg polyethylene glycol (PEG) solution of BAY 94-8862

DRUG

Finerenone (BAY 94-8862) immediate release tablet

20 mg BAY 94-8862 administered as 2 x 10 mg IR tablets

DRUG

Eplerenone (Inspra®)

Single oral dose of 50 mg eplerenone

DRUG

Placebo

Matching placebo (solution/tablet) corresponding to BAY 94-8862 dose in respective dose step

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
46 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-03-29
Primary Completion
2010-11-30
Completion
2011-05-17

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01473108 on ClinicalTrials.gov