Recruiting NCT07413666
A Study of ORX489 in Healthy Adult Participants, Aged 18 to 60 Years
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: ORX489 Tablets, Placebo Tablets.
- Who it may be relevant to
- Registry conditions: Healthy Adult Male and Female Volunteers. Basic parameters: 18 years — 60 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 Safety, Tolerability, Pharmacokinetic, Food Effect, and Proof-of-Concept Study of Single and Multiple Doses of ORX489 in Healthy Adults
Overview
Characterize the safety, tolerability and pharmacokinetics of ORX489 following single and multiple doses.
Interventions
- Drug ORX489 Tablets
ORX489 Tablets - Other Placebo Tablets
Placebo Tablets
Primary outcome measures
- Part A [Time frame: From enrollment to the Follow-Up Visit 7 days post-discharge]
- Part B [Time frame: From enrollment to the Follow-Up Visit 7 days post-discharge]]
- Part C [Time frame: From enrollment to the Follow-Up Visit 7 days post-discharge]]
- Part D: [Time frame: From enrollment to the Follow-Up Visit 7 days post-discharge]
Secondary outcome measures (10)
- Cmax [Time frame: Pre-dose and multiple post-dose timepoints, up to 48 hours]
- Tmax [Time frame: Pre-dose and multiple post-dose timepoints, up to 48 hours]
- AUClast [Time frame: Pre-dose and multiple post-dose timepoints, up to 48 hours]
- T 1/2 (terminal elimination half-life) [Time frame: Pre-dose and multiple post-dose timepoints, up to 48 hours]
- Cmax [Time frame: Pre-dose and multiple post-dose timepoints, up to 48 hours]
- Tmax [Time frame: Pre-dose and multiple post-dose timepoints, up to 48 hours]
- AUClast [Time frame: Pre-dose and multiple post-dose timepoints, up to 48 hours]
- T 1/2 (terminal elimination half-life) [Time frame: Pre-dose and multiple post-dose timepoints, up to 48 hours]
- Mean sleep latency in the Maintenance of Wakefulness Test (MWT) [Time frame: Part D: Day 1-2]
- Karolinska Sleepiness Scale score [Time frame: Part D: 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 D: Participants must be at least 18 years of age and no more than 60 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 · 1 center
- Celerion — Lincoln
Identifiers
NCT: NCT07413666 · Protocol ORX489-101