Healthy Adult Male and Female Volunteers
Conditions
Keywords
Healthy Volunteers orexin-2 receptor agonist
Brief summary
Characterize the safety, tolerability and pharmacokinetics of ORX489 following single and multiple doses.
Interventions
DRUGORX489 Tablets
ORX489 Tablets
OTHERPlacebo Tablets
Placebo Tablets
Sponsors
Centessa Pharmaceuticals (UK) Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blind (investigator- and subject-blinded)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean sleep latency in the Maintenance of Wakefulness Test (MWT) | Part D: Day 1-2 | Mean sleep latency in the Maintenance of Wakefulness Test (MWT) for ORX489 versus placebo: MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake |
| T 1/2 (terminal elimination half-life) | Pre-dose and multiple post-dose timepoints, up to 48 hours | The time required for the terminal phase blood concentration of ORX489 to decrease by half in participants receiving ORX489 |
| Karolinska Sleepiness Scale score | Part D: Day 1-2 | Karolinska Sleepiness Scale score for ORX489 versus placebo: 9-point scale, ranging from "extremely alert" (1) to "very sleepy, great effort keeping awake, fighting sleep |
| Cmax | Pre-dose and multiple post-dose timepoints, up to 48 hours | Maximum Observed Plasma Concentration for ORX489 in participants receiving ORX489 |
| Tmax | Pre-dose and multiple post-dose timepoints, up to 48 hours | Time of Maximum Concentration for ORX489 in participants receiving ORX489 |
| AUClast | Pre-dose and multiple post-dose timepoints, up to 48 hours | Area Under the Plasma Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration for ORX489 in participants receiving ORX489 |
Countries
United States
Contacts
CONTACTORX489 Centessa Program Lead ORX489 Centessa Program Lead
CONTACTCelerion Program Lead CA49982 United States, Nebraska [Recruiting]
Outcome results
None listed