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This will be an open-label, non-randomized, single oral dose study in healthy male subjects.
All subjects will receive a single oral dose of 10 mL of [14C]-RPC1063 Solution (0.1 mg/mL), containing NMT 1.3 MBq (37 μCi) 14C.
Subjects will be screened for eligibility to participate in the study up to 28 days before dosing. Subjects will be admitted to the clinical unit on the morning of Day -1 prior to IMP administration. Subjects will be dosed on the morning of Day 1 following a standard breakfast, and will remain resident in the clinic until up to 168 h after dosing. It is planned that subjects will be released as a group when all subjects have achieved a mass balance cumulative recovery of >90% or if <1% of the dose administered has been collected in urine and faeces within 2 separate, consecutive 24 h periods. This may be earlier than 168 h post-dose but no sooner than 96 h post-dose. In this case, collection of all samples (blood, urine and faeces) will be stopped and the subjects will undergo discharge assessments. If this criteria has not been met by all subjects on Day 8, home collections of urine and faeces may be requested at the discretion of the investigator for individual subjects. A follow-up phone call will take place 5 to 10 days after discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]-RPC1063 Solution (0.1 g/mL) | Experimental | 1 mg; 10 mL [14C]-RPC1063 HCl oral dose containing NMT 1.3 MBq (37 μCi) 14C |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RPC1063 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of elimination of [14C]-RPC1063 | Total recovery of radioactivity in urine and feces expressed as a percentage of total radioactive dose in each 24 h interval and cumulatively | Up to 4 weeks |
| Pharmacokinetic- amount of drug excreted | Cumulative amount of drug excreted unchanged in the drug in urine | Up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic- Cmax | Maximum observed concentration | Up to 8 days |
| Pharmacokinetic- Tmax | Time at maximum observed concentration | Up to 8 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Tran, Pharm.D | Celgene Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Clinical | Nottingham | NG11 6JS | United Kingdom |
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| ID | Term |
|---|---|
| C000607776 | ozanimod |
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| Pharmacokinetic- AUC0-last | Area under the curve from 0 time to last measurable concentration | Up to 8 days |
| Pharmacokinetic- AUC0-inf | Area under the curve from 0 time extrapolated to infinity | Up to 8 days |
| Pharmacokinetic- λz | Elimination rate constant | Up to 8 days |
| Pharmacokinetic- t1/2 | Terminal elimination half-life | Up to 8 days |
| Pharmacokinetic- CL/F | Clearance, the apparent volume cleared of parent drug per unit time after extravascular administration | Up to 8 days |
| Pharmacokinetic- Vz/F | The apparent volume of distribution after extravascular administration | Up to 8 days |
| Pharmacokinetic- CLr | Renal clearance | Up to 8 days |
| Adverse Events (AEs) | Number of participants with adverse events | Approximately 2 months |