Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
Study NCT ID:
NCT07413666
Status:
RECRUITING
Last Update Posted:
2026-02-25
First Post:
2026-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of ORX489 in Healthy Adult Participants, Aged 18 to 60 Years
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double-blind (investigator- and subject-blinded)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 212}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-25', 'type': 'ESTIMATED'}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-23', 'studyFirstSubmitDate': '2026-02-09', 'studyFirstSubmitQcDate': '2026-02-09', 'lastUpdatePostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part A', 'timeFrame': 'From enrollment to the Follow-Up Visit 7 days post-discharge', 'description': '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.'}, {'measure': 'Part B', 'timeFrame': 'From enrollment to the Follow-Up Visit 7 days post-discharge]', 'description': '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'}, {'measure': 'Part C', 'timeFrame': 'From enrollment to the Follow-Up Visit 7 days post-discharge]', 'description': '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'}, {'measure': 'Part D:', 'timeFrame': 'From enrollment to the Follow-Up Visit 7 days post-discharge', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Cmax', 'timeFrame': 'Pre-dose and multiple post-dose timepoints, up to 48 hours', 'description': 'Maximum Observed Plasma Concentration for ORX489 in participants receiving ORX489'}, {'measure': 'Tmax', 'timeFrame': 'Pre-dose and multiple post-dose timepoints, up to 48 hours', 'description': 'Time of Maximum Concentration for ORX489 in participants receiving ORX489'}, {'measure': 'AUClast', 'timeFrame': 'Pre-dose and multiple post-dose timepoints, up to 48 hours', 'description': 'Area Under the Plasma Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration for ORX489 in participants receiving ORX489'}, {'measure': 'T 1/2 (terminal elimination half-life)', 'timeFrame': 'Pre-dose and multiple post-dose timepoints, up to 48 hours', 'description': 'The time required for the terminal phase blood concentration of ORX489 to decrease by half in participants receiving ORX489'}, {'measure': 'Cmax', 'timeFrame': 'Pre-dose and multiple post-dose timepoints, up to 48 hours', 'description': 'Maximum Observed Plasma Concentration for ORX489 in participants receiving ORX489 in the fasted and fed state.'}, {'measure': 'Tmax', 'timeFrame': 'Pre-dose and multiple post-dose timepoints, up to 48 hours', 'description': 'Time of Maximum Concentration for ORX489 in participants receiving ORX489 in the fast and fed state'}, {'measure': 'AUClast', 'timeFrame': 'Pre-dose and multiple post-dose timepoints, up to 48 hours', 'description': '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'}, {'measure': 'T 1/2 (terminal elimination half-life)', 'timeFrame': 'Pre-dose and multiple post-dose timepoints, up to 48 hours', 'description': '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'}, {'measure': 'Mean sleep latency in the Maintenance of Wakefulness Test (MWT)', 'timeFrame': 'Part D: Day 1-2', 'description': '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'}, {'measure': 'Karolinska Sleepiness Scale score', 'timeFrame': 'Part D: Day 1-2', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthy Volunteers orexin-2 receptor agonist'], 'conditions': ['Healthy Adult Male and Female Volunteers']}, 'descriptionModule': {'briefSummary': 'Characterize the safety, tolerability and pharmacokinetics of ORX489 following single and multiple doses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males or females as determined by assessments at the Screening Visit.\n* 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\n\nExclusion Criteria:\n\n* 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.\n* History of seizure disorder, any other condition that increases the risk of seizure\n* Has a clinically significant sleep disorder, including insomnia or sleep apnea'}, 'identificationModule': {'nctId': 'NCT07413666', 'briefTitle': 'A Study of ORX489 in Healthy Adult Participants, Aged 18 to 60 Years', 'organization': {'class': 'INDUSTRY', 'fullName': 'Centessa Pharmaceuticals (UK) Limited'}, 'officialTitle': 'A Safety, Tolerability, Pharmacokinetic, Food Effect, and Proof-of-Concept Study of Single and Multiple Doses of ORX489 in Healthy Adults', 'orgStudyIdInfo': {'id': 'Protocol ORX489-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A', 'description': 'SAD Study in Healthy Adults: ORX489 and Placebo', 'interventionNames': ['Drug: ORX489 Tablets', 'Other: Placebo Tablets']}, {'type': 'EXPERIMENTAL', 'label': 'Part B', 'description': 'Food-effect Evaluation in Healthy Adults: ORX489', 'interventionNames': ['Drug: ORX489 Tablets']}, {'type': 'EXPERIMENTAL', 'label': 'Part C', 'description': 'MAD Study in Healthy Adults: ORX489 and Placebo', 'interventionNames': ['Drug: ORX489 Tablets', 'Other: Placebo Tablets']}, {'type': 'EXPERIMENTAL', 'label': 'Part D', 'description': 'SAD Study in Acutely Sleep-Deprived Healthy Adults: ORX489 and Placebo', 'interventionNames': ['Drug: ORX489 Tablets', 'Other: Placebo Tablets']}], 'interventions': [{'name': 'ORX489 Tablets', 'type': 'DRUG', 'description': 'ORX489 Tablets', 'armGroupLabels': ['Part A', 'Part B', 'Part C', 'Part D']}, {'name': 'Placebo Tablets', 'type': 'OTHER', 'description': 'Placebo Tablets', 'armGroupLabels': ['Part A', 'Part C', 'Part D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68502', 'city': 'Lincoln', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Celerion', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}], 'centralContacts': [{'name': 'ORX489 Centessa Program Lead ORX489 Centessa Program Lead', 'role': 'CONTACT', 'email': 'ORX489-101study@centessa.com', 'phone': '617-468-5770'}, {'name': 'Celerion Program Lead CA49982 United States, Nebraska [Recruiting]', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centessa Pharmaceuticals (UK) Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}