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

Centessa Pharmaceuticals

Status and phase: Enrolling; Phase 1

Conditions: Healthy Adult Male and Female Volunteers

Treatments: Drug: ORX489 Tablets; Other: Placebo Tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT07413666

Protocol ORX489-101

Details and patient eligibility

About

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

Enrollment: 212 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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212 participants in 4 patient groups

Part A

Experimental group

Description:

SAD Study in Healthy Adults: ORX489 and Placebo

Treatment:

Other: Placebo Tablets

Drug: ORX489 Tablets

Part B

Experimental group

Description:

Food-effect Evaluation in Healthy Adults: ORX489

Treatment:

Drug: ORX489 Tablets

Part C

Experimental group

Description:

MAD Study in Healthy Adults: ORX489 and Placebo

Treatment:

Other: Placebo Tablets

Drug: ORX489 Tablets

Part D

Experimental group

Description:

SAD Study in Acutely Sleep-Deprived Healthy Adults: ORX489 and Placebo

Treatment:

Other: Placebo Tablets

Drug: ORX489 Tablets