Characterize the safety, tolerability and pharmacokinetics of ORX489 following single and multiple doses.
Eligibility
Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
Accepted
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
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.
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