Clinical Trials in the USA / NCT07413666
Recruiting
Phase 1
A Study of ORX489 in Healthy Adult Participants, Aged 18 to 60 Years
NCT07413666 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Healthy Adult Male and Female Volunteers
Investigational drug(s) / intervention(s)
ORX489 TabletsPlacebo Tablets
ORX489 Tablets: ORX489 Tablets
Placebo Tablets: Placebo Tablets
Study summary
Characterize the safety, tolerability and pharmacokinetics of ORX489 following single and multiple doses.
Eligibility
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
Primary outcome measure(s)
- Part A — From enrollment to the Follow-Up Visit 7 days post-discharge
Incidence and severity of Treatment-Emergent Adverse Events \[Safety and Tolerability\] as assessed by AEs and SAEs of oral single ascending doses of ORX489 in healthy adult participants. - Part B — From enrollment to the Follow-Up Visit 7 days post-discharge]
Incidence and severity of Treatment-Emergent Adverse Events \[Safety and Tolerability\] as assessed by AEs and SAEs of oral single ascending doses of ORX489 in the fasted and fed states - Part C — From enrollment to the Follow-Up Visit 7 days post-discharge]
Incidence and severity of Treatment-Emergent Adverse Events \[Safety and Tolerability\] as assessed by AEs and SAEs of oral multiple ascending doses of ORX489 in healthy adult participants - Part D: — From enrollment to the Follow-Up Visit 7 days post-discharge
Incidence and severity of Treatment-Emergent Adverse Events \[Safety and Tolerability\] as assessed by AEs and SAEs of oral single oral doses of ORX489 in sleep-deprived healthy adult participants
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Celerion | Lincoln | Nebraska | 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 NCT07413666 on ClinicalTrials.gov ↗ ← All trials in the USA