Dose Proportionality Study With BAY94-8862 IR (Immediate Release) Tablets
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)
2 other identifiers
interventional
25
1 country
1
Brief Summary
This study should estimate the dose proportionality of BAY94-8862 IR tablets.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 heart-failure
Started Sep 2012
Shorter than P25 for phase_1 heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2012
CompletedStudy Start
First participant enrolled
September 17, 2012
CompletedFirst Posted
Study publicly available on registry
September 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 28, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2013
CompletedFebruary 7, 2022
January 1, 2022
2 months
September 14, 2012
January 27, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dose proportionality of BAY94-8862 exposure in plasma when given as 1.25, 2.5, 5.0, 7.5 and 10 mg IR tablets
0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 28 & 48 h
Secondary Outcomes (1)
Number of participants with adverse events as a measure of safety and tolerability of BAY94-8862
Up to 48 h
Study Arms (5)
BAY94-8862 (1.25mg)
EXPERIMENTALsingle dose BAY94-8862 IR tablet 1.25mg
BAY94-8862 (2.5mg)
EXPERIMENTALsingle dose BAY94-8862 IR tablet 2.5mg
BAY94-8862 (5mg)
EXPERIMENTALsingle dose BAY94-8862 IR tablet 5mg
BAY94-8862 (7.5mg)
EXPERIMENTALsingle dose BAY94-8862 IR tablet 7.5mg
BAY94-8862 (10mg)
EXPERIMENTALsingle dose BAY94-8862 IR tablet 10mg
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (1)
CRS Clinical-Research-Services Mönchengladbach GmbH
Mönchengladbach, North Rhine-Westphalia, 41061, Germany
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2012
First Posted
September 19, 2012
Study Start
September 17, 2012
Primary Completion
November 28, 2012
Study Completion
March 21, 2013
Last Updated
February 7, 2022
Record last verified: 2022-01