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| ID | Type | Description | Link |
|---|---|---|---|
| 1010456 | Registry Identifier | IRAS ID |
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Part 1 aims to investigate the relative bioavailability of a new formulation and to assess potential food effects following oral administration of SYT-510. Part 1 will then guide dosing in Part 2, a multiple dose study which aims to assess safety, tolerability and pharmacokinetic of multiple SYT-510 administrations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Relative bioavailability and food effect | Experimental | Randomised, open label, single-dose, three period, three-sequence crossover study to evaluate the relative bioavailability (rBA) of a new oral formulation of SYT-510 under fasting conditions and the effect of food in healthy participants. |
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| Part 2: Multiple Ascending Dose | Experimental | Randomised, double-blind, placebo-controlled multiple ascending dose (MAD) study in healthy participants to assess the safety, tolerability and pharmacokinetics (PK) of SYT-510 after repeated administrations. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYT-510 | Drug | Oral formulation A fasted |
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| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Maximum Observed Concentration (Cmax) of SYT-510 | Up to 72 hours post-dose | |
| Part 1: Area under the concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUC0-tlast) of SYT-510 | Up to 72 hours post-dose | |
| Part 1: AUC of SYT-510 | Up to several days post last dose | |
| Part 2: Incidence and severity of treatment related adverse event, including abnormal laboratory events to evaluate the safety and tolerability profile of multiple ascending doses of SYT-510 | Up to Day 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Incidence and severity of treatment related adverse event, including abnormal laboratory events to evaluate the safety and tolerability profile of single doses of SYT-510 | Up to Day 4 | |
| Part 2: Maximum observed concentration (Cmax) of SYT-510 | Up to Day 14 |
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Inclusion Criteria:
Exclusion Criteria:
Male and female participants of non-childbearing potential
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Richmond Pharmacology Ltd | London | United Kingdom |
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| SYT-510 | Drug | Oral formulation B fasted |
|
| SYT-510 | Drug | Oral formulation A fed |
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| Placebo | Drug | Oral formulation |
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| Part 2: Time of maximal plasma concentration (tmax) of SYT-510 | Up to Day 14 |
| Part 2: AUCtau of SYT-510 | Up to Day 14 |
| Part 2: Terminal elimination half-life (t1/2) of SYT-510 | Up to several days post last dose |
| Part 2: Accumulation ratio of SYT-510 | Up to Day 14 |