Clinical Trials in the USA / NCT07082829
Recruiting
Phase 1
A Study of ORX142 in Healthy Adult Subjects, Including Subjects 18 to 80 Years of Age
NCT07082829 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Excessive Daytime Sleepiness
Investigational drug(s) / intervention(s)
ORX142 TabletsPlacebo Tablets
ORX142 Tablets: ORX142 Tablets
Placebo Tablets: Placebo Tablets
Study summary
Characterize the safety, tolerability and pharmacokinetics of ORX142 following single and multiple doses.
Eligibility
Key Inclusion Criteria:
1. 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
2. For Part D:
a .Participants must be at least 60 years of age and no more than 80 years of age at the Screening
Key Exclusion Criteria:
1. 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.
2. History of seizure disorder, any other condition that increases the risk of seizure
3. Has a clinically significant sleep disorder, including insomnia or sleep apnea.
Primary outcome measure(s)
- Part A: Incidence and severity of Treatment-Emergent Adverse Events of oral single ascending doses of ORX142 in healthy adult subjects — From enrollment to the Follow-Up Visit 13 days post-discharge
Safety and Tolerability as assessed by AEs and SAEs - Part B: Incidence and severity of Treatment-Emergent Adverse Events of oral single ascending doses of ORX142 in the fasted and fed states — From enrollment to the Follow-Up Visit 13 days post-discharge
Safety and Tolerability as assessed by AEs and SAEs - Part C: Incidence and severity of Treatment-Emergent Adverse Events of oral multiple ascending doses of ORX142 in healthy adult subjects — From enrollment to the Follow-Up Visit 13 days post-discharge
Safety and Tolerability as assessed by AEs and SAEs - Part D: Incidence and severity of Treatment-Emergent Adverse Events of oral single oral doses of ORX142 in healthy older adult subjects — From enrollment to the Follow-Up Visit 13 days post-discharge
Safety and Tolerability as assessed by AEs and SAEs - 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 — From enrollment to the Follow-Up Visit 13 days post-discharge
Safety and Tolerability as assessed by AEs and SAEs
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| Site #1 | Lincoln | Nebraska | Recruiting |
| Site #2 | Eatontown | New Jersey | Recruiting |
| Site #3 | New York | New York | Recruiting |
More Centessa Pharmaceuticals (UK) Limited trials in the USA
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07082829 on ClinicalTrials.gov ↗ ← All trials in the USA