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

Sponsor: Bayer
Study ID: NCT01473108
Phase: PHASE1
Status: Completed

Conditions

Clinical Pharmacology

Eligibility Criteria

Sex: MALE
Age: 18 Years - 46 Years
Healthy Volunteers: Accepted

Interventions

Finerenone (BAY 94-8862) PEG solution — DRUG
2.5, 5, 10, 20 mg polyethylene glycol (PEG) solution of BAY 94-8862
Finerenone (BAY 94-8862) immediate release tablet — DRUG
20 mg BAY 94-8862 administered as 2 x 10 mg IR tablets
Eplerenone (Inspra®) — DRUG
Single oral dose of 50 mg eplerenone
Placebo — DRUG
Matching placebo (solution/tablet) corresponding to BAY 94-8862 dose in respective dose step

Study Details

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.

Key Dates

Start date: Mar 29, 2010
Status verified: Jan 2022
Primary completion: Nov 30, 2010
Completion: May 17, 2011

Study Design

Enrollment: 67 participants (actual)
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Arms

Experimental: Finerenone (20 mg solution)
3-fold crossover of single dose 20 mg BAY 94-8862 solution, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo.
Experimental: Finerenone (10 mg solution)
3-fold crossover of single dose 10 mg BAY 94-8862 solution, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo.
Experimental: Finerenone (5 mg solution)
3-fold crossover of single dose 5 mg BAY 94-8862 solution, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo.
Experimental: Finerenone (20 mg as tablets)
3-fold crossover of single dose 20 mg BAY 94-8862 as 2 x 10 mg tablet, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo.
Experimental: Finerenone (2.5 mg solution)
3-fold crossover of single dose 2.5 mg BAY 94-8862 solution, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo.

Primary Outcome Measure

Log10 (10*urinary Na+/K+ ratio) (Parameter for natriuresis) [ Time Frame: Up to 26 hours post-dose ]