Trials / Completed
CompletedNCT01473108
Study to Investigate the Natriuretic Effects, Safety, Tolerability and Pharmacokinetics of BAY94-8862
Study to Investigate the Effectiveness of Different Single Oral Doses of BAY94-8862 on Natriuresis After Administration of 0.5 mg Fludrocortisone (Astonin H®) With 50 mg Eplerenone (Inspra®) as Active Control in Healthy Male Subjects in a Randomized, Single-blind, Placebo-controlled, Combined 3-fold Crossover and Parallel-group Design
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 67 (actual)
- Sponsor
- Bayer · Industry
- Sex
- Male
- Age
- 18 Years – 46 Years
- Healthy volunteers
- Accepted
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.
Detailed description
Clinical pharmacology
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2010-03-29
- Primary completion
- 2010-11-30
- Completion
- 2011-05-17
- First posted
- 2011-11-17
- Last updated
- 2022-02-09
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT01473108. Inclusion in this directory is not an endorsement.