A non-randomized, single-center trial to determine the excretion balance and the metabolic profile of 14C-GRT6006 in healthy male subjects.
Completed
- Conditions
- pijnpain
- Registration Number
- NL-OMON35855
- Lead Sponsor
- Grunenthal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
Inclusion Criteria
Gender: male
Age: 45 * 65 years, inclusive
BMI: 20.0 * 28.0 kg/m2, inclusive
Exclusion Criteria
Suffering from: hepatitis B, 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 90 days from the start of the study or in case of donating more than 1.5 liter 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>Pharmacokinetics<br /><br><br /><br>The matrices to be analyzed for total radioactivity will be whole blood,<br /><br>plasma, expired air, urine, and feces.<br /><br><br /><br>The analytes to be determined in whole blood and plasma are GRT6006, and<br /><br>optionally GRT6006 metabolites.<br /><br><br /><br>Optionally, selected urine and feces samples will be analyzed for GRT6006 and<br /><br>GRT6006 metabolites.<br /><br><br /><br>Expired air samples will be collected for the assay of radiocarbon dioxide.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Safety<br /><br><br /><br>The following safety parameters will be assessed at defined time points:<br /><br>* Vital signs (blood pressure, pulse rate, respiratory rate).<br /><br>* Oxygen saturation (pulse oximetry).<br /><br>* 12-lead ECG.<br /><br>* Laboratory monitoring.<br /><br>* Physical examination including body temperature.<br /><br>* Continuous stationary monitoring (1-lead ECG, pulse rate, respiratory rate,<br /><br>oxygen saturation).<br /><br>* Ambulatory monitoring (pulse rate and oxygen saturation).<br /><br>* Adverse events at defined time points and spontaneously reported at any time.<br /><br>* Optional additional safety investigations from blood.</p><br>