NCT07082829

A Study of ORX142 in Healthy Adult Subjects, Including Subjects 18 to 80 Years of Age

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: Phase 1
• Study type: Interventional
• Enrollment: 208 (estimated)
• Sponsor: Centessa Pharmaceuticals (UK) Limited · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Characterize the safety, tolerability and pharmacokinetics of ORX142 following single and multiple doses.

Conditions

• Excessive Daytime Sleepiness

Interventions

Type	Name	Description
DRUG	ORX142 Tablets	ORX142 Tablets
OTHER	Placebo Tablets	Placebo Tablets

Timeline

• Start date: 2025-06-30
• Primary completion: 2026-06-15
• Completion: 2026-06-15
• First posted: 2025-07-24
• Last updated: 2025-12-24

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study