Trial Condition(s):
Heart Failure
Dose proportionality study with BAY94-8862 IR (immediate release) tablets
Bayer Identifier:
15481
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Study Completed
Trial Purpose
This study should estimate the dose proportionality of BAY94-8862 IR tablets.
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Phase
1
Could I receive a placebo?
No
Products
Finerenone (BAY94-8862)
Accepts Healthy Volunteers
Yes
Where to Participate
Loading...
Locations
| Locations | |
|---|---|
Locations CRS Clinical-Research-Services Mönchengladbach GmbH Mönchengladbach, Germany, 41061 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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
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 tabletsTimeframe: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 28 & 48 h
Secondary Outcome
- Number of participants with adverse events as a measure of safety and tolerability of BAY94-8862Timeframe: Up to 48 h
Additional Information
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