Excessive Daytime SleepinessPhase 1NCT07082829
A Study of ORX142 in Healthy Adult Subjects, Including Subjects 18 to 80 Years of Age
A Phase 1 study testing ORX142 Tablets in people with Excessive Daytime Sleepiness, run by Centessa Pharmaceuticals (UK) Limited at 3 sites in United States.
Trial summary
Characterize the safety, tolerability and pharmacokinetics of ORX142 following single and multiple doses. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Excessive Daytime Sleepiness
- What is being tested?
- ORX142 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 208 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Jun 2025to 15 Jun 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males or females as determined by assessments at the Screening Visit.
- For Parts A, B, C, and E:
- Participants must be at least 18 years of age and no more than 55 years of age at the Screening
- For Part D:
- a .Participants must be at least 60 years of age and no more than 80 years of age at the Screening
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Site #2
Eatontown, New Jersey, 07724
- Recruiting
Site #1
Lincoln, Nebraska, 68502
- Recruiting
Site #3
New York, New York, 10019
About this study
Official title: A Randomized, Double-blind, Sponsor-open, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Single and Multiple Ascending Doses of ORX142 in Healthy Adults, Single Doses of ORX142 in Healthy Older Adults, and a Single Dose Crossover, Proof-of-concept Study of ORX142 in Acutely Sleep-deprived Healthy Subjects
Characterize the safety, tolerability and pharmacokinetics of ORX142 following single and multiple doses.
- Conditions
- Excessive Daytime Sleepiness
- Being tested
- ORX142 Tablets, Placebo Tablets
- Keywords
- Excessive Daytime Sleepiness, orexin-2 receptor agonist
- Medical subject headings
- Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORX142 TabletsDrug
ORX142 Tablets
Placebo TabletsOther
Placebo Tablets
| Study group | Role | What they receive |
|---|---|---|
| Part A: SAD Study in Healthy Adults | Experimental | Not described Receives: Drug: ORX142 Tablets; Other: Placebo Tablets |
| Part B: Food-effect Evaluation in Healthy Adults | Experimental | Not described Receives: Drug: ORX142 Tablets |
| Part C: MAD Study in Healthy Adults | Experimental | Not described Receives: Drug: ORX142 Tablets; Other: Placebo Tablets |
| Part D: Evaluation of a Single Dose in Healthy Older Adults | Experimental | Not described Receives: Drug: ORX142 Tablets; Other: Placebo Tablets |
| Part E: PoC Study in Acutely Sleep-deprived Healthy Adults | Experimental | Not described Receives: Drug: ORX142 Tablets; Other: Placebo Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Incidence and severity of Treatment-Emergent Adverse Events of oral single ascending doses of ORX142 in healthy adult subjects
Safety and Tolerability as assessed by AEs and SAEs
Measured: From enrollment to the Follow-Up Visit 13 days post-discharge
Part B: Incidence and severity of Treatment-Emergent Adverse Events of oral single ascending doses of ORX142 in the fasted and fed states
Safety and Tolerability as assessed by AEs and SAEs
Measured: From enrollment to the Follow-Up Visit 13 days post-discharge
Part C: Incidence and severity of Treatment-Emergent Adverse Events of oral multiple ascending doses of ORX142 in healthy adult subjects
Safety and Tolerability as assessed by AEs and SAEs
Measured: From enrollment to the Follow-Up Visit 13 days post-discharge
Part D: Incidence and severity of Treatment-Emergent Adverse Events of oral single oral doses of ORX142 in healthy older adult subjects
Safety and Tolerability as assessed by AEs and SAEs
Measured: From enrollment to the Follow-Up Visit 13 days post-discharge
Part E: Incidence and severity of Treatment-Emergent Adverse Events of oral of single oral doses of ORX142 in acutely sleep-deprived healthy adult subjects
Safety and Tolerability as assessed by AEs and SAEs
Measured: From enrollment to the Follow-Up Visit 13 days post-discharge
Secondary outcomes (10)
Cmax: Maximum Observed Plasma Concentration for ORX142 in subjects receiving ORX142
Measured: Pre-dose and multiple post-dose timepoints, up to 48 hours
Tmax: Time of Maximum Concentration for ORX142 in subjects receiving ORX142
Measured: Pre-dose and multiple post-dose timepoints, up to 48 hours
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for ORX142 in subjects receiving ORX142
Measured: Pre-dose and multiple post-dose timepoints, up to 48 hours
T 1/2 (terminal elimination half-life): The time required for the terminal phase blood concentration of ORX142 to decrease by half in subjects receiving ORX142
Measured: Pre-dose and multiple post-dose timepoints, up to 48 hours
Cmax: Maximum Observed Plasma Concentration for ORX142 in subjects receiving ORX142 in the fasted and fed state.
Measured: Pre-dose and multiple post-dose timepoints, up to 48 hours
Tmax: Time of Maximum Concentration for ORX142 in subjects receiving ORX142 in the fast and fed state
Measured: Pre-dose and multiple post-dose timepoints, up to 48 hours
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for ORX142 in subjects receiving ORX142 in the fast and fed state
Measured: Pre-dose and multiple post-dose timepoints, up to 48 hours
T 1/2 (terminal elimination half-life): The time required for the terminal phase blood concentration of ORX142 to decrease by half in subjects receiving ORX142 in the fast and fed state
Measured: Pre-dose and multiple post-dose timepoints, up to 48 hours
Mean sleep latency in the Maintenance of Wakefulness Test (MWT) for ORX142 versus placebo.
Measured: Part E: Day 2
Karolinska Sleepiness Scale score for ORX142 versus placebo
Measured: Part E: Day 1-2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start30 Jun 2025
- Primary completion15 Jun 2026 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Excessive Daytime SleepinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centessa Pharmaceuticals (UK) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07082829
- Sponsor's protocol ID
- ORX142-0101
- Status last verified
- Dec 2025
- First submitted
- 25 Jun 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Sponsor-open, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Single and Multiple Ascending Doses of ORX142 in Healthy Adults, Single Doses of ORX142 in Healthy Older Adults, and a Single Dose Crossover, Proof-of-concept Study of ORX142 in Acutely Sleep-deprived Healthy Subjects
- ClinicalTrials.gov ID
- NCT07082829
- Acronym / sponsor ID
- ORX142-0101
- Conditions
- Excessive Daytime Sleepiness
- Keywords
- Excessive Daytime Sleepiness, orexin-2 receptor agonist
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Centessa Pharmaceuticals (UK) LimitedIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Characterize the safety, tolerability and pharmacokinetics of ORX142 following single and multiple doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part A: SAD Study in Healthy Adults | Experimental | Drug: ORX142 Tablets, Other: Placebo Tablets |
| Part B: Food-effect Evaluation in Healthy Adults | Experimental | Drug: ORX142 Tablets |
| Part C: MAD Study in Healthy Adults | Experimental | Drug: ORX142 Tablets, Other: Placebo Tablets |
| Part D: Evaluation of a Single Dose in Healthy Older Adults | Experimental | Drug: ORX142 Tablets, Other: Placebo Tablets |
| Part E: PoC Study in Acutely Sleep-deprived Healthy Adults | Experimental | Drug: ORX142 Tablets, Other: Placebo Tablets |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy males or females as determined by assessments at the Screening Visit.
- For Part D:
- a .Participants must be at least 60 years of age and no more than 80 years of age at the Screening
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ORX142 TabletsORX142 Tablets | Drug | Part A: SAD Study in Healthy Adults, Part B: Food-effect Evaluation in Healthy Adults, Part C: MAD Study in Healthy Adults, Part D: Evaluation of a Single Dose in Healthy Older Adults, Part E: PoC Study in Acutely Sleep-deprived Healthy Adults |
| Placebo TabletsPlacebo Tablets | Other | Part A: SAD Study in Healthy Adults, Part C: MAD Study in Healthy Adults, Part D: Evaluation of a Single Dose in Healthy Older Adults, Part E: PoC Study in Acutely Sleep-deprived Healthy Adults |
Primary outcome
Part A: Incidence and severity of Treatment-Emergent Adverse Events of oral single ascending doses of ORX142 in healthy adult subjects
Time frame: From enrollment to the Follow-Up Visit 13 days post-discharge
Safety and Tolerability as assessed by AEs and SAEs
Part B: Incidence and severity of Treatment-Emergent Adverse Events of oral single ascending doses of ORX142 in the fasted and fed states
Time frame: From enrollment to the Follow-Up Visit 13 days post-discharge
Safety and Tolerability as assessed by AEs and SAEs
Part C: Incidence and severity of Treatment-Emergent Adverse Events of oral multiple ascending doses of ORX142 in healthy adult subjects
Time frame: From enrollment to the Follow-Up Visit 13 days post-discharge
Safety and Tolerability as assessed by AEs and SAEs
Part D: Incidence and severity of Treatment-Emergent Adverse Events of oral single oral doses of ORX142 in healthy older adult subjects
Time frame: From enrollment to the Follow-Up Visit 13 days post-discharge
Safety and Tolerability as assessed by AEs and SAEs
Part E: Incidence and severity of Treatment-Emergent Adverse Events of oral of single oral doses of ORX142 in acutely sleep-deprived healthy adult subjects
Time frame: From enrollment to the Follow-Up Visit 13 days post-discharge
Safety and Tolerability as assessed by AEs and SAEs
10 secondary outcomes
Cmax: Maximum Observed Plasma Concentration for ORX142 in subjects receiving ORX142
Time frame: Pre-dose and multiple post-dose timepoints, up to 48 hours
Tmax: Time of Maximum Concentration for ORX142 in subjects receiving ORX142
Time frame: Pre-dose and multiple post-dose timepoints, up to 48 hours
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for ORX142 in subjects receiving ORX142
Time frame: Pre-dose and multiple post-dose timepoints, up to 48 hours
T 1/2 (terminal elimination half-life): The time required for the terminal phase blood concentration of ORX142 to decrease by half in subjects receiving ORX142
Time frame: Pre-dose and multiple post-dose timepoints, up to 48 hours
Cmax: Maximum Observed Plasma Concentration for ORX142 in subjects receiving ORX142 in the fasted and fed state.
Time frame: Pre-dose and multiple post-dose timepoints, up to 48 hours
Tmax: Time of Maximum Concentration for ORX142 in subjects receiving ORX142 in the fast and fed state
Time frame: Pre-dose and multiple post-dose timepoints, up to 48 hours
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for ORX142 in subjects receiving ORX142 in the fast and fed state
Time frame: Pre-dose and multiple post-dose timepoints, up to 48 hours
T 1/2 (terminal elimination half-life): The time required for the terminal phase blood concentration of ORX142 to decrease by half in subjects receiving ORX142 in the fast and fed state
Time frame: Pre-dose and multiple post-dose timepoints, up to 48 hours
Mean sleep latency in the Maintenance of Wakefulness Test (MWT) for ORX142 versus placebo.
Time frame: Part E: Day 2
Karolinska Sleepiness Scale score for ORX142 versus placebo
Time frame: Part E: Day 1-2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ORX142 Tablets in people with Excessive Daytime Sleepiness, run by Centessa Pharmaceuticals (UK) Limited at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ORX142 Centessa Program Lead (617-468-5770, ORX142-0101study@centessa.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: Incidence and severity of Treatment-Emergent Adverse Events of oral single ascending doses of ORX142 in healthy adult subjects (time frame: From enrollment to the Follow-Up Visit 13 days post-discharge). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.