Dose Proportionality Study With BAY94-8862 IR (Immediate Release) Tablets
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
BAY94-8862 (1.25mg)
BAY94-8862 (2.5mg)
BAY94-8862 (5mg)
BAY94-8862 (7.5mg)
BAY94-8862 (10mg)
Sponsored by
About this trial
This is an interventional other trial for Heart Failure focused on measuring Cardiac disorders
Eligibility Criteria
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)
Sites / Locations
- CRS Clinical-Research-Services Mönchengladbach GmbH
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
BAY94-8862 (1.25mg)
BAY94-8862 (2.5mg)
BAY94-8862 (5mg)
BAY94-8862 (7.5mg)
BAY94-8862 (10mg)
Arm Description
single dose BAY94-8862 IR tablet 1.25mg
single dose BAY94-8862 IR tablet 2.5mg
single dose BAY94-8862 IR tablet 5mg
single dose BAY94-8862 IR tablet 7.5mg
single dose BAY94-8862 IR tablet 10mg
Outcomes
Primary Outcome Measures
Dose proportionality of BAY94-8862 exposure in plasma when given as 1.25, 2.5, 5.0, 7.5 and 10 mg IR tablets
Secondary Outcome Measures
Number of participants with adverse events as a measure of safety and tolerability of BAY94-8862
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01687920
Brief Title
Dose Proportionality Study With BAY94-8862 IR (Immediate Release) Tablets
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 17, 2012 (Actual)
Primary Completion Date
November 28, 2012 (Actual)
Study Completion Date
March 21, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study should estimate the dose proportionality of BAY94-8862 IR tablets.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Cardiac disorders
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BAY94-8862 (1.25mg)
Arm Type
Experimental
Arm Description
single dose BAY94-8862 IR tablet 1.25mg
Arm Title
BAY94-8862 (2.5mg)
Arm Type
Experimental
Arm Description
single dose BAY94-8862 IR tablet 2.5mg
Arm Title
BAY94-8862 (5mg)
Arm Type
Experimental
Arm Description
single dose BAY94-8862 IR tablet 5mg
Arm Title
BAY94-8862 (7.5mg)
Arm Type
Experimental
Arm Description
single dose BAY94-8862 IR tablet 7.5mg
Arm Title
BAY94-8862 (10mg)
Arm Type
Experimental
Arm Description
single dose BAY94-8862 IR tablet 10mg
Intervention Type
Drug
Intervention Name(s)
BAY94-8862 (1.25mg)
Intervention Type
Drug
Intervention Name(s)
BAY94-8862 (2.5mg)
Intervention Type
Drug
Intervention Name(s)
BAY94-8862 (5mg)
Intervention Type
Drug
Intervention Name(s)
BAY94-8862 (7.5mg)
Intervention Type
Drug
Intervention Name(s)
BAY94-8862 (10mg)
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Number of participants with adverse events as a measure of safety and tolerability of BAY94-8862
Time Frame
Up to 48 h
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
46 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
Facility Name
CRS Clinical-Research-Services Mönchengladbach GmbH
City
Mönchengladbach
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
41061
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://clinicaltrials.bayer.com/
Description
Click here to find results for studies related to Bayer products
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Dose Proportionality Study With BAY94-8862 IR (Immediate Release) Tablets
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