Trial Condition(s):
Clinical Pharmacology
Study to investigate the natriuretic effects, safety, tolerability and pharmacokinetics of BAY94-8862
Bayer Identifier:
13786
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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.
Inclusion Criteria
- Healthy male white subjects - 18 to 46 years of age - Body mass index (BMI): 18 - 29.9 kg/m²
Exclusion Criteria
- 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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Neuss, Germany, 41460 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
Randomized
Blinding:
Single Blind
Assignment:
Crossover Assignment
Trial Arms:
5
Primary Outcome
- Log10 (10*urinary Na+/K+ ratio) (Parameter for natriuresis)Timeframe: 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)Timeframe: 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)Timeframe: Up to 60 hours after administration
Secondary Outcome
- Number of participants with adverse eventsTimeframe: Up to 28 days
Additional Information
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