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

Phase 1RecruitingNCT07413666

Centessa Pharmaceuticals (UK) Limited212 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

212

Conditions

Healthy Adult Male and Female Volunteers

Interventions

ORX489 TabletsDRUG

ORX489 Tablets

Placebo TabletsOTHER

Placebo Tablets

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Celerion

Lincoln, Nebraska, United States

RECRUITING

Outcomes

Primary Outcomes

Part A

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.

Time frame: From enrollment to the Follow-Up Visit 7 days post-discharge

Part B

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

Time frame: From enrollment to the Follow-Up Visit 7 days post-discharge]

Part C

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

Time frame: From enrollment to the Follow-Up Visit 7 days post-discharge]

Part D:

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

Time frame: From enrollment to the Follow-Up Visit 7 days post-discharge

Secondary Outcomes

Cmax

Maximum Observed Plasma Concentration for ORX489 in participants receiving ORX489

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

Tmax

Time of Maximum Concentration for ORX489 in participants receiving ORX489

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

AUClast

Central Contacts

ORX489 Centessa Program Lead ORX489 Centessa Program Lead

CONTACT

617-468-5770 ORX489-101study@centessa.com

Celerion Program Lead CA49982 United States, Nebraska [Recruiting]

CONTACT

Data from ClinicalTrials.gov

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