A Study of ORX489 in Healthy Adult Participants, Aged 18 to 60 Years
- Summary
- Characterize the safety, tolerability and pharmacokinetics of ORX489 following single and multiple doses.
- Short title
- A Study of ORX489 in Healthy Adult Participants, Aged 18 to 60 Years
- Official title
- A Safety, Tolerability, Pharmacokinetic, Food Effect, and Proof-of-Concept Study of Single and Multiple Doses of ORX489 in Healthy Adults
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2027-06-30
- First posted
- 2026-02-17
- Registry last updated
- 2026-02-25
- Primary completion date
- 2027-06-30
- Start date
- 2026-02-25
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Centessa Pharmaceuticals (UK) Limited
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07413666
- ClinicalTrials.gov ID
- NCT07413666
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Double masking
- Masking description
- Double-blind (investigator- and subject-blinded)
- Masked roles
- Participants, Investigators
Part A
Timeframe: 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
Timeframe: 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
Timeframe: 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:
Timeframe: 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
Cmax
Timeframe: Pre-dose and multiple post-dose timepoints, up to 48 hours
Maximum Observed Plasma Concentration for ORX489 in participants receiving ORX489
Tmax
Timeframe: Pre-dose and multiple post-dose timepoints, up to 48 hours
Time of Maximum Concentration for ORX489 in participants receiving ORX489
AUClast
Timeframe: 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
T 1/2 (terminal elimination half-life)
Timeframe: 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
Cmax
Timeframe: Pre-dose and multiple post-dose timepoints, up to 48 hours
Maximum Observed Plasma Concentration for ORX489 in participants receiving ORX489 in the fasted and fed state.
Tmax
Timeframe: Pre-dose and multiple post-dose timepoints, up to 48 hours
Time of Maximum Concentration for ORX489 in participants receiving ORX489 in the fast and fed state
AUClast
Timeframe: 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 in the fast and fed state
T 1/2 (terminal elimination half-life)
Timeframe: 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 in the fast and fed state
Mean sleep latency in the Maintenance of Wakefulness Test (MWT)
Timeframe: 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
Karolinska Sleepiness Scale score
Timeframe: 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
- Sex
- All
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 60 Years
- Healthy volunteers
- Yes
- 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
- 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
- CelerionLincoln, United StatesRecruiting