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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-002615-65 | EudraCT Number | ||
| 18pc0101026h0001 | Other Grant/Funding Number | The Japan Agency for Medical Research and Development |
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| Name | Class |
|---|---|
| Quotient Sciences | INDUSTRY |
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This single centre, open-label, non-randomised, single period, single-dose study in healthy male subjects was designed and conducted to assess the mass balance recovery, PK, metabolite profile and metabolite identification of SJP-0008.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]SJP-0008 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]SJP-0008 | Drug | Single oral dose of [14C]SJP-0008 |
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| Measure | Description | Time Frame |
|---|---|---|
| Mass balance recovery of total radioactivity in all excreta after a single oral dose of [14C]SJP-0008 | Mass balance recovery of total radioactivity in all excreta by analysing the total radioactivity and metabolic profile in plasma, urine and faeces samples. | Until the mass balance criteria for all participants have been met (estimated up to Day 10) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) of SJP-0008 and SNJ-2026 | Up to Day 8 | |
| Area under the concentration-time curve from time zero to last measurable concentration (AUC0-last) of SJP-0008 and SNJ-2026 | Up to Day 8 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Somasekhara Menakuru | Quotient Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences | Ruddington | Nottingham | NG11 6JS | United Kingdom |
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| Area under concentration-time curve from time zero to infinity (AUC0-inf) of SJP-0008 and SNJ-2026 | Up to Day 8 |
| Area under the concentration-time curve from time of the last measurable concentration to infinity as a percentage of the area under the curve extrapolated to infinity (AUCextrap) of SJP-0008 and SNJ-2026 | Up to Day 8 |
| Time to maximum plasma concentration (Tmax) of SJP-0008 and SNJ-2026 | Up to Day 8 |
| Half-life (T1/2) of SJP-0008 and SNJ-2026 | Up to Day 8 |
| First order rate constant associated with the terminal (log-linear) portion of the curve (Lambda-z) of SJP-0008 and SNJ-2026 | Up to Day 8 |
| Percentage of participants with adverse events (AEs) | Until the mass balance criteria for all participants have been met (estimated up to Day 10) |