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NCT Number: NCT07413666

A Study of ORX489 in Healthy Adult Participants, Aged 18 to 60 Years

Characterize the safety, tolerability and pharmacokinetics of ORX489 following single and multiple doses.

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Key information

Conditions

Healthy Adult Male and Female Volunteers

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Lincoln, Nebraska, 68502, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ORX489 Tablets

Drug

ORX489 Tablets

Placebo tablets

Other

Placebo Tablets

Primary outcomes

  1. Part A

    Time frame: 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.

  2. Part B

    Time frame: 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

  3. Part C

    Time frame: 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

  4. Part D:

    Time frame: 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

Secondary outcomes

  1. Cmax

    Time frame: Pre-dose and multiple post-dose timepoints, up to 48 hours

    Maximum Observed Plasma Concentration for ORX489 in participants receiving ORX489

  2. Tmax

    Time frame: Pre-dose and multiple post-dose timepoints, up to 48 hours

    Time of Maximum Concentration for ORX489 in participants receiving ORX489

  3. AUClast

    Time frame: 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

  4. T 1/2 (terminal elimination half-life)

    Time frame: 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

  5. Cmax

    Time frame: 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.

  6. Tmax

    Time frame: 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

  7. AUClast

    Time frame: 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

  8. T 1/2 (terminal elimination half-life)

    Time frame: 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

  9. Mean sleep latency in the Maintenance of Wakefulness Test (MWT)

    Time frame: 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

  10. Karolinska Sleepiness Scale score

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Celerion Program Lead CA49982 United States, Nebraska [Recruiting]

CONTACT

ORX489 Centessa Program Lead ORX489 Centessa Program Lead

CONTACT

[email protected]

617-468-5770

Sponsors and collaborators

Lead sponsor

Centessa Pharmaceuticals (UK) Limited

Industry

Registry information

Official study title

A Safety, Tolerability, Pharmacokinetic, Food Effect, and Proof-of-Concept Study of Single and Multiple Doses of ORX489 in Healthy Adults

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 17, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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