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| Name | Class |
|---|---|
| Hammersmith Medicines Research | OTHER |
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This Phase 1 clinical trial will assess the safety, tolerability and pharmacokinetics (PK) of a solid capsule form of NTP42:KVA4 in male and female healthy volunteers. In a randomised, 3-way cross-over study, the Trial will involve 3 dose sessions where all volunteers will receive 3 single doses of NTP42:KVA4. In two of the dose sessions, volunteers will be fasted where, in one, they will be given the NTP42:KVA4 capsule and, in another, they will be given NTP42:KVA4 in oral liquid form. To test the effect of food on drug absorption (PK), the volunteers will also be given the NTP42:KVA4 capsule after eating a full breakfast.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NTP42:KVA4 Capsule | Experimental |
| |
| NTP42:KVA4 Oral Suspension | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NTP42:KVA4 Capsule | Drug | Single doses of NTP42:KVA4 administered to healthy volunteers as a capsule |
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety and tolerability of NTP42:KVA4 when given as a capsule in healthy volunteers | Adverse events (AEs) | Up to 48-hour post-dose |
| Evaluation of the pharmacokinetics of NTP42:KVA4 when given as a capsule in healthy volunteers | Pharmacokinetic parameter: Area under the curve (AUC) | Predose, 0.75-, 2-, 4, 6-, 8-, 12-, 24- & 48-hours post-dosing |
| Evaluation of the effect of food on the pharmacokinetics of NTP42:KVA4 when given as a capsule in healthy volunteers | Pharmacokinetic parameter: Area under the curve (AUC) | Predose, 0.75-, 2-, 4, 6-, 8-, 12-, 24- & 48-hours post-dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the pharmacodynamics effects of NTP42:KVA4 when given as a capsule in healthy volunteers | TXA2-induced platelet aggregometry | Predose, 2-, 6-, 24- & 48-hours post-dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Takahiro Yamamoto, MD | Hammersmith Medicines Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammersmith Medicines Research | London | NW10 7EW | United Kingdom |
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| NTP42:KVA4 Liquid | Drug | Single doses of NTP42:KVA4 administered to healthy volunteers as a liquid |
|