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

Part of paid clinical trials in Lincoln, Nebraska.

Sponsor
Centessa Pharmaceuticals (UK) Limited
Study ID
NCT07082829
Phase
PHASE1
Status
Recruiting

Conditions

  • Excessive Daytime Sleepiness

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • ORX142 Tablets — DRUG
    ORX142 Tablets
  • Placebo Tablets — OTHER
    Placebo Tablets

Study Details

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

Key Dates

Start date
Jun 30, 2025
Status verified
Dec 2025
Primary completion
Jun 15, 2026
Completion
Jun 15, 2026

Study Design

Enrollment
208 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: SAD Study in Healthy Adults
  • Experimental: Part B: Food-effect Evaluation in Healthy Adults
  • Experimental: Part C: MAD Study in Healthy Adults
  • Experimental: Part D: Evaluation of a Single Dose in Healthy Older Adults
  • Experimental: Part E: PoC Study in Acutely Sleep-deprived Healthy Adults

Primary Outcome Measure

Part A: Incidence and severity of Treatment-Emergent Adverse Events of oral single ascending doses of ORX142 in healthy adult subjects [ Time Frame: From enrollment to the Follow-Up Visit 13 days post-discharge ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Site #1LincolnNebraska68502-
Site #2EatontownNew Jersey07724-
Site #3New YorkNew York10019-

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