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Recruiting NCT07082829

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

Phase I Interventional Excessive Daytime Sleepiness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ORX142 Tablets, Placebo Tablets.
Who it may be relevant to
Registry conditions: Excessive Daytime Sleepiness. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Drug ORX142 Tablets
    ORX142 Tablets
  • Other Placebo Tablets
    Placebo Tablets

Primary outcome measures

  • 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]
  • Part B: Incidence and severity of Treatment-Emergent Adverse Events of oral single ascending doses of ORX142 in the fasted and fed states [Time frame: From enrollment to the Follow-Up Visit 13 days post-discharge]
  • Part C: Incidence and severity of Treatment-Emergent Adverse Events of oral multiple ascending doses of ORX142 in healthy adult subjects [Time frame: From enrollment to the Follow-Up Visit 13 days post-discharge]
  • Part D: Incidence and severity of Treatment-Emergent Adverse Events of oral single oral doses of ORX142 in healthy older adult subjects [Time frame: From enrollment to the Follow-Up Visit 13 days post-discharge]
  • Part E: Incidence and severity of Treatment-Emergent Adverse Events of oral of single oral doses of ORX142 in acutely sleep-deprived healthy adult subjects [Time frame: From enrollment to the Follow-Up Visit 13 days post-discharge]
Secondary outcome measures (10)
  • Cmax: Maximum Observed Plasma Concentration for ORX142 in subjects receiving ORX142 [Time frame: Pre-dose and multiple post-dose timepoints, up to 48 hours]
  • Tmax: Time of Maximum Concentration for ORX142 in subjects receiving ORX142 [Time frame: Pre-dose and multiple post-dose timepoints, up to 48 hours]
  • AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for ORX142 in subjects receiving ORX142 [Time frame: Pre-dose and multiple post-dose timepoints, up to 48 hours]
  • T 1/2 (terminal elimination half-life): The time required for the terminal phase blood concentration of ORX142 to decrease by half in subjects receiving ORX142 [Time frame: Pre-dose and multiple post-dose timepoints, up to 48 hours]
  • Cmax: Maximum Observed Plasma Concentration for ORX142 in subjects receiving ORX142 in the fasted and fed state. [Time frame: Pre-dose and multiple post-dose timepoints, up to 48 hours]
  • Tmax: Time of Maximum Concentration for ORX142 in subjects receiving ORX142 in the fast and fed state [Time frame: Pre-dose and multiple post-dose timepoints, up to 48 hours]
  • AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for ORX142 in subjects receiving ORX142 in the fast and fed state [Time frame: Pre-dose and multiple post-dose timepoints, up to 48 hours]
  • T 1/2 (terminal elimination half-life): The time required for the terminal phase blood concentration of ORX142 to decrease by half in subjects receiving ORX142 in the fast and fed state [Time frame: Pre-dose and multiple post-dose timepoints, up to 48 hours]
  • Mean sleep latency in the Maintenance of Wakefulness Test (MWT) for ORX142 versus placebo. [Time frame: Part E: Day 2]
  • Karolinska Sleepiness Scale score for ORX142 versus placebo [Time frame: Part E: Day 1-2]

Eligibility criteria

Inclusion criteria

  • Healthy males or females as determined by assessments at the Screening Visit.

For Parts A, B, C, and E:

a. Participants must be at least 18 years of age and no more than 55 years of age at the Screening

  • For Part D:

a .Participants must be at least 60 years of age and no more than 80 years of age at the Screening

Exclusion criteria

  • Presence of significant cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, malignancy, endocrine, neurological, or psychiatric disease, as determined by medical history, physical examination, and screening investigations.
  • History of seizure disorder, any other condition that increases the risk of seizure
  • Has a clinically significant sleep disorder, including insomnia or sleep apnea.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 3 centers
  • Site #1 — Lincoln
  • Site #2 — Eatontown
  • Site #3 — New York

Identifiers

NCT: NCT07082829 · ORX142-0101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗