Safety, Tolerability and Pharmacokinetics of NTP42:KVA4

NCT04919863 ↗

Phase 1 Completed 79 enrolled ATXA Therapeutics Limited Hammersmith Medicines Research · collab

RandomizedSequentialDouble-blindTreatment

Summary

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.

Timeline

Start: 2021-05-24
Primary completion: 2022-01-20
Completion: 2022-01-20

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	NTP42	Unknown	0.25 mg	Oral
Subject	NTP42	Unknown	9 mg	Oral
Subject	NTP42	Unknown	15 mg	Oral
Subject	NTP42	Unknown	135 mg	Oral
Subject	NTP42	Unknown	243 mg	Oral

Indications

No indication recorded.