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
2 other identifiers
interventional
67
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 29, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 17, 2011
CompletedFirst Submitted
Initial submission to the registry
August 18, 2011
CompletedFirst Posted
Study publicly available on registry
November 17, 2011
CompletedFebruary 9, 2022
January 1, 2022
8 months
August 18, 2011
January 27, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Log10 (10*urinary Na+/K+ ratio) (Parameter for natriuresis)
Up to 26 hours post-dose
AUC (Area under the concentration vs time curve from zero to infinity after single (first) dose for both BAY 94-8862 and eplerenone)
Up to 60 hours after administration
Cmax (Maximum observed drug concentration in measured matrix after single dose administration for both BAY 94-8862 and eplerenone)
Up to 60 hours after administration
Secondary Outcomes (1)
Number of participants with adverse events
Up to 28 days
Study Arms (5)
Finerenone (20 mg solution)
EXPERIMENTAL3-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.
Finerenone (10 mg solution)
EXPERIMENTAL3-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.
Finerenone (5 mg solution)
EXPERIMENTAL3-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.
Finerenone (20 mg as tablets)
EXPERIMENTAL3-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.
Finerenone (2.5 mg solution)
EXPERIMENTAL3-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.
Interventions
2.5, 5, 10, 20 mg polyethylene glycol (PEG) solution of BAY 94-8862
20 mg BAY 94-8862 administered as 2 x 10 mg IR tablets
Single oral dose of 50 mg eplerenone
Matching placebo (solution/tablet) corresponding to BAY 94-8862 dose in respective dose step
Eligibility Criteria
You may qualify if:
- Healthy male white subjects
- to 46 years of age
- Body mass index (BMI): 18 - 29.9 kg/m²
You may not qualify if:
- Clinically relevant findings in medical history or in the physical examination
- Systolic blood pressure below 100 or above 140 mmHg
- Diastolic blood pressure below 50 or above 90 mmHg
- Heart rate below 45 or above 95 beats / min
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (1)
Unknown Facility
Neuss, North Rhine-Westphalia, 41460, Germany
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2011
First Posted
November 17, 2011
Study Start
March 29, 2010
Primary Completion
November 30, 2010
Study Completion
May 17, 2011
Last Updated
February 9, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.