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

NCT ID: NCT07082829

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2026-06-15

Brief Summary

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

Detailed Description

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Conditions

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Excessive Daytime Sleepiness

Keywords

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Excessive Daytime Sleepiness orexin-2 receptor agonist

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Double-blind (investigator- and subject-blinded)

Study Groups

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Part A: SAD Study in Healthy Adults

Group Type EXPERIMENTAL

ORX142 Tablets

Intervention Type DRUG

ORX142 Tablets

Placebo Tablets

Intervention Type OTHER

Placebo Tablets

Part B: Food-effect Evaluation in Healthy Adults

Group Type EXPERIMENTAL

ORX142 Tablets

Intervention Type DRUG

ORX142 Tablets

Part C: MAD Study in Healthy Adults

Group Type EXPERIMENTAL

ORX142 Tablets

Intervention Type DRUG

ORX142 Tablets

Placebo Tablets

Intervention Type OTHER

Placebo Tablets

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

Group Type EXPERIMENTAL

ORX142 Tablets

Intervention Type DRUG

ORX142 Tablets

Placebo Tablets

Intervention Type OTHER

Placebo Tablets

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

Group Type EXPERIMENTAL

ORX142 Tablets

Intervention Type DRUG

ORX142 Tablets

Placebo Tablets

Intervention Type OTHER

Placebo Tablets

Interventions

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ORX142 Tablets

ORX142 Tablets

Intervention Type DRUG

Placebo Tablets

Placebo Tablets

Intervention Type OTHER

Eligibility Criteria

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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

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centessa Pharmaceuticals (UK) Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Site #1

Lincoln, Nebraska, United States

Site Status RECRUITING

Site #2

Eatontown, New Jersey, United States

Site Status RECRUITING

Site #3

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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ORX142 Centessa Program Lead

Role: CONTACT

Phone: 617-468-5770

Email: [email protected]

Other Identifiers

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ORX142-0101

Identifier Type: -

Identifier Source: org_study_id