check_circleStudy Completed

Heart Failure

Bayer Identifier:

15481

ClinicalTrials.gov Identifier:

NCT01687920

EudraCT Number:

2012-003055-10

EU CT Number:

Not Available
Dose proportionality study with BAY94-8862 IR (immediate release) tablets

Trial purpose

This study should estimate the dose proportionality of BAY94-8862 IR tablets.

Key Participants Requirements

Sex

Male

Age

18 - 46 Years
  • - Healthy male subject
    - Age: 18 to 46 years (inclusive) at the first screening examination
    - Ethnicity: White
    - Body mass index (BMI): >= 18 and <= 29.9 kg / m²
  • - Clinically relevant findings in the ECG (electrocardiogram) such as a second- or third-degree AV block, prolongation of the QRS complex over 120 msec
    - Systolic blood pressure below 100 or above 140 mmHg
    - Diastolic blood pressure below 50 or above 90 mmHg
    - Heart rate below 50 or above 95 beats/ min
    - Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), human immune deficiency virus antibodies (anti-HIV 1+2)
    - Participation in another clinical study during the preceding 3 months (Last Treatment from previous study to First Treatment of new study)

Trial summary

Enrollment Goal
25
Trial Dates
September 2012 - March 2013
Phase
Phase 1
Could I Receive a placebo
No
Products
Finerenone (BAY94-8862)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
CRS Clinical-Research-Services Mönchengladbach GmbHMönchengladbach, 41061, Germany

Primary Outcome

  • Dose proportionality of BAY94-8862 exposure in plasma when given as 1.25, 2.5, 5.0, 7.5 and 10 mg IR tablets
    date_rangeTime Frame:
    0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 28 & 48 h
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of participants with adverse events as a measure of safety and tolerability of BAY94-8862
    date_rangeTime Frame:
    Up to 48 h
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Single center, randomized, open-label, 5-fold crossover study in healthy male subjects to investigate the pharmacokinetic dose proportionality of BAY94-8862 given as 5 different single oral IR tablet doses (1.25, 2.5, 5.0, 7.5 and 10 mg)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
5

Additional Information

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