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| Name | Class |
|---|---|
| Hammersmith Medicines Research | OTHER |
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A Phase I clinical trial to assess the safety, tolerability, and pharmacokinetics of NTP42:KVA4 following oral administration in a randomized, double-blind, placebo-controlled trial. The trial will involve of 2 phases, a single ascending dose (SAD) phase and a multiple ascending dose (MAD) phase. The SAD phase will incorporate a food effect arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NTP42:KVA4 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NTP42:KVA4 | Drug | Single ascending dose (SAD) or multiple ascending dose (MAD) of NTP42:KVA4 administered to healthy volunteers as an oral suspension. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety and tolerability of single and repeated doses of NTP42:KVA4 in healthy volunteers. | Adverse events (AEs) | Up to 48-hour post-dose. |
| Evaluation of the pharmacokinetics of single and repeated doses of NTP42:KVA4 in healthy volunteers. | Pharmacokinetic parameter: Area under the Curve (AUC) | Predose, 0.16, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 18, 24, 36 & 48 hours post-dosing. |
| Evaluation of the effect of food on the pharmacokinetics of NTP42:KVA4 in healthy volunteers. | Pharmacokinetic parameter: Area under the Curve (AUC) | Predose, 0.16, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 18, 24, 36 & 48 hours post-dosing. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the pharmacodynamics effects of NTP42:KVA4 in healthy volunteers. | TXA2-induced platelet aggregometry | Predose, 0.75, 2, 4, 8, 12 & 24 hours post-dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Malcolm Boyce, MD | Hammersmith Medicines Reserach | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammersmith Medicines Research | London | NW10 7EW | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38178863 | Derived | Reid HM, Maginn M, Perkins CM, Mulvaney EP, Boyce M, Yamamoto T, Kinsella BT. Evaluation of NTP42, a novel thromboxane receptor antagonist, in a first-in-human phase I clinical trial. Front Pharmacol. 2023 Dec 21;14:1296188. doi: 10.3389/fphar.2023.1296188. eCollection 2023. |
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| Placebo | Drug | Placebo, matched to corresponding doses of NTP42:KVA4 administered to healthy volunteers as an oral solution. |
|