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The main purpose of this study is to determine the mass balance recovery and the metabolite profile of a single dose of carbon-14 ([14C]) GRT6019
This is an open-label, non-randomized, single-dose study in healthy male participants. It is planned to enroll a total of ten participants to ensure data in a minimum of six participants. The estimated time for duration of study will be up to 11 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]GRT6019 | Experimental | Participants will be dosed on the morning of Day 1 following an overnight fast of a minimum of 8 h. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]GRT6019 | Drug | Single administration in a single dosing period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative amount of total radioactivity excreted (CumAe) | To determine the mass balance recovery of total radioactivity in all excreta (urine and faeces) after a single dose of [14C]GRT6019 | Day -1 (Admission), Day 1 up to Days 47-48. |
| Cumulative amount of total radioactivity excreted expressed as a percentage of the radioactive dose administered (Cum%Ae) | To determine the mass balance recovery of total radioactivity in all excreta (urine and faeces) after a single dose of [14C]GRT6019 | Day -1 (Admission), Day 1 up to Days 47-48. |
| Metabolite profling and structural identification | To perform metabolite profiling, structural identification, and quantification analysis from plasma, urine and faecal samples | Day -1 (Admission), Day 1 up to Days 47-48. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Grünenthal Clinical Trial Information | Contact | +49 241 569 3223 | clinical-trials@grunenthal.com | |
| Transparency and Public Disclosure Coordinator | Contact | clinical-trials@grunenthal.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences | Recruiting | Nottingham | NG11 6JS | United Kingdom |
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