A Study of ORX142 in Healthy Adult Subjects, Including Subjects 18 to 80 Years of Age

Centessa Pharmaceuticals

Status and phase: Enrolling; Phase 1

Conditions: Excessive Daytime Sleepiness

Treatments: Other: Placebo Tablets; Drug: ORX142 Tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT07082829

ORX142-0101

Details and patient eligibility

About

Characterize the safety, tolerability and pharmacokinetics of ORX142 following single and multiple doses.

Enrollment: 208 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Healthy males or females as determined by assessments at the Screening Visit.

   For Parts A, B, C, and E:

   a. Participants must be at least 18 years of age and no more than 55 years of age at the Screening

2. 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:

1. 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.
2. History of seizure disorder, any other condition that increases the risk of seizure
3. Has a clinically significant sleep disorder, including insomnia or sleep apnea.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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208 participants in 5 patient groups

Part A: SAD Study in Healthy Adults

Experimental group

Treatment:

Drug: ORX142 Tablets

Other: Placebo Tablets

Part B: Food-effect Evaluation in Healthy Adults

Experimental group

Treatment:

Drug: ORX142 Tablets

Part C: MAD Study in Healthy Adults

Experimental group

Treatment:

Drug: ORX142 Tablets

Other: Placebo Tablets

Part D: Evaluation of a Single Dose in Healthy Older Adults

Experimental group

Treatment:

Drug: ORX142 Tablets

Other: Placebo Tablets

Part E: PoC Study in Acutely Sleep-deprived Healthy Adults

Experimental group

Treatment:

Drug: ORX142 Tablets

Other: Placebo Tablets