Single center, open label, non-randomized, non-placebo controlled study to investigate the pharmacokinetics, metabolic disposition, and mass balance after single administration of 20 mg [14C]neladenoson bialanate (oral solution) in healthy male subjects.
Completed
- Conditions
- heart failure10019280
- Registration Number
- NL-OMON44620
- Lead Sponsor
- Bayer AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
Inclusion Criteria
healthy male subjects
light skin (Caucasian)
18 - 55 years of age, inclusive
BMI 18.0 - 29.9 kilograms/meter2
smoking less than 10 cigarettes per day
Exclusion Criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Measure the cumulative amount (as well as the time course) of drug-related,<br /><br>radioactive-labeled material excreted in urine and feces<br /><br>following a single oral dose of 20 mg neladenoson bialanate blended with<br /><br>radiolabeled [14C]neladenoson bialanate.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Assess the safety and tolerability of 20 mg neladenoson bialanate administered<br /><br>as an oral solution in healthy male subjects.</p><br>