pijn pain
Conditions
Interventions
Active substance [14C]-GRT6006
2.33 MBq 14C labeled GRT6006
Sponsors
Grunenthal
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Gender: male Age: 45 * 65 years, inclusive BMI: 20.0 * 28.0 kg/m2, inclusive
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics The matrices to be analyzed for total radioactivity will be whole blood, plasma, expired air, urine, and feces. The analytes to be determined in whole blood and plasma are GRT6006, and optionally GRT6006 metabolites. Optionally, selected urine and feces samples will be analyzed for GRT6006 and GRT6006 metabolites. Expired air samples will be collected for the assay of radiocarbon dioxide. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety The following safety parameters will be assessed at defined time points: * Vital signs (blood pressure, pulse rate, respiratory rate). * Oxygen saturation (pulse oximetry). * 12-lead ECG. * Laboratory monitoring. * Physical examination including body temperature. * Continuous stationary monitoring (1-lead ECG, pulse rate, respiratory rate, oxygen saturation). * Ambulatory monitoring (pulse rate and oxygen saturation). * Adverse events at defined time points and spontaneously reported at any time. * Optional additional safety investigations from blood. | — |
Countries
Netherlands
Outcome results
None listed