check_circleStudy Completed

Clinical Pharmacology

Bayer Identifier:

13786

ClinicalTrials.gov Identifier:

NCT01473108

EudraCT Number:

2010-018500-90

EU CT Number:

Not Available
Study to investigate the natriuretic effects, safety, tolerability and pharmacokinetics of BAY94-8862

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.

Key Participants Requirements

Sex

Male

Age

18 - 46 Years
  • - Healthy male white subjects
    - 18 to 46 years of age
    - Body mass index (BMI): 18 - 29.9 kg/m²
  • - 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
67
Trial Dates
March 2010 - May 2011
Phase
Phase 1
Could I Receive a placebo
Yes
Products
Finerenone (BAY94-8862)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Neuss, 41460, Germany

Primary Outcome

  • Log10 (10*urinary Na+/K+ ratio) (Parameter for natriuresis)
    date_rangeTime Frame:
    Up to 26 hours post-dose
    enhanced_encryption
    Safety Issue:
    No
  • AUC (Area under the concentration vs time curve from zero to infinity after single (first) dose for both BAY 94-8862 and eplerenone)
    date_rangeTime Frame:
    Up to 60 hours after administration
    enhanced_encryption
    Safety Issue:
    No
  • Cmax (Maximum observed drug concentration in measured matrix after single dose administration for both BAY 94-8862 and eplerenone)
    date_rangeTime Frame:
    Up to 60 hours after administration
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of participants with adverse events
    date_rangeTime Frame:
    Up to 28 days
    enhanced_encryption
    Safety Issue:
    Yes

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

Additional Information

Click here to find results for studies related to Bayer products