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NCT04919863

Safety, Tolerability and Pharmacokinetics of NTP42:KVA4

Completed Phase 1 Last updated 24 February 2022
What this trial tests

Phase 1 trial testing NTP42:KVA4 in Healthy in 79 participants. Completed in 20 January 2022.

Timeline
24 May 2021
Primary endpoint
20 January 2022
20 January 2022

Quick facts

Lead sponsorATXA Therapeutics Limited
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsequential
Maskingdouble
Primary purposetreatment
Enrollment79
Start date24 May 2021
Primary completion20 January 2022
Estimated completion20 January 2022
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

ATXA Therapeutics Limited — full company profile →

Who can join

Adults 18 to 55, male only, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The thromboxane receptor antagonist <i>NTP42</i> promotes beneficial adaptation and preserves cardiac function in experimental models of right heart overload.
    Mulvaney EP, Renzo F, Adão R, Dupre E, et al · · 2022 · cited 6× · PMID 36588576 · DOI 10.3389/fcvm.2022.1063967
  2. Evaluation of <i>NTP42</i>, a novel thromboxane receptor antagonist, in a first-in-human phase I clinical trial.
    Reid HM, Maginn M, Perkins CM, Mulvaney EP, et al · · 2023 · cited 2× · PMID 38178863 · DOI 10.3389/fphar.2023.1296188

Verify or expand the search:

Other recruiting trials for Healthy

Currently open trials in the same condition.

Other ATXA Therapeutics Limited trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04919863.

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