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

February 23, 2026 updated by: Centessa Pharmaceuticals (UK) Limited

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
212

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Celerion Program Lead CA49982 United States, Nebraska [Recruiting]

Study Locations

  • United States
    • Nebraska
      • Lincoln, Nebraska, United States, 68502
        • Recruiting
        • Celerion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part A
SAD Study in Healthy Adults: ORX489 and Placebo
Other: Placebo Tablets
Placebo Tablets
Drug: ORX489 Tablets
ORX489 Tablets
Experimental: Part B
Food-effect Evaluation in Healthy Adults: ORX489
Drug: ORX489 Tablets
ORX489 Tablets
Experimental: Part C
MAD Study in Healthy Adults: ORX489 and Placebo
Other: Placebo Tablets
Placebo Tablets
Drug: ORX489 Tablets
ORX489 Tablets
Experimental: Part D
SAD Study in Acutely Sleep-Deprived Healthy Adults: ORX489 and Placebo
Other: Placebo Tablets
Placebo Tablets
Drug: ORX489 Tablets
ORX489 Tablets

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the Follow-Up Visit 7 days post-discharge
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
From enrollment to the Follow-Up Visit 7 days post-discharge]
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
From enrollment to the Follow-Up Visit 7 days post-discharge]
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
From enrollment to the Follow-Up Visit 7 days post-discharge

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: Pre-dose and multiple post-dose timepoints, up to 48 hours
Maximum Observed Plasma Concentration for ORX489 in participants receiving ORX489
Pre-dose and multiple post-dose timepoints, up to 48 hours
Tmax
Time Frame: Pre-dose and multiple post-dose timepoints, up to 48 hours
Time of Maximum Concentration for ORX489 in participants receiving ORX489
Pre-dose and multiple post-dose timepoints, up to 48 hours
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
Pre-dose and multiple post-dose timepoints, up to 48 hours
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
Pre-dose and multiple post-dose timepoints, up to 48 hours
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.
Pre-dose and multiple post-dose timepoints, up to 48 hours
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
Pre-dose and multiple post-dose timepoints, up to 48 hours
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
Pre-dose and multiple post-dose timepoints, up to 48 hours
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
Pre-dose and multiple post-dose timepoints, up to 48 hours
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
Part D: Day 1-2
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
Part D: Day 1-2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centessa Pharmaceuticals (UK) Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 25, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Protocol ORX489-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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