Study 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

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

Trial Dates

September 2012 - March 2013

Phase

Phase 1

Could I Receive a placebo

Products

Finerenone (BAY94-8862)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed	CRS Clinical-Research-Services Mönchengladbach GmbH	Mönchengladbach, 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
Time Frame:
0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 28 & 48 h
Safety Issue:
No

Secondary Outcome

Number of participants with adverse events as a measure of safety and tolerability of BAY94-8862
Time Frame:
Up to 48 h
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

Additional Information

Click here to find results for studies related to Bayer products