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A Randomized, Double-blind, Sponsor-open, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Single and Multiple Ascending Doses of ORX142 in Healthy Adults, Single Doses of ORX142 in Healthy Older Adults, and a Single Dose Crossover, Proof-of-concept Study of ORX142 in Acutely Sleep-deprived Healthy Subjects

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Trial Profile

A Randomized, Double-blind, Sponsor-open, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Single and Multiple Ascending Doses of ORX142 in Healthy Adults, Single Doses of ORX142 in Healthy Older Adults, and a Single Dose Crossover, Proof-of-concept Study of ORX142 in Acutely Sleep-deprived Healthy Subjects

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 01 Aug 2025

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At a glance

  • Drugs ORX 142 (Primary)
  • Indications Hypersomnia
  • Focus Adverse reactions; First in man; Proof of concept
  • Sponsors Centessa Pharmaceuticals

Most Recent Events

  • 04 Jul 2025 According to a Centessa Pharmaceuticals media release, company announces that it will receive US$4.8 million in milestone payments from Centessa Pharmaceuticals to initiate development of of this phase 1 trial.
  • 16 Jun 2025 According to a Centessa Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has cleared the IND to initiate a Phase 1 clinical study of ORX142 in healthy volunteers, The Company plans to initiate the first-in-human Phase 1 clinical study imminently, with clinical data expected this year, which is expected to enable a dose selection for planned studies evaluating ORX142 in patients.
  • 18 Nov 2024 New trial record

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