Purpose

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

Condition

Eligibility

Eligible Ages
Between 18 Years and 60 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Key Inclusion Criteria: 1. Healthy males or females as determined by assessments at the Screening Visit. 1. For Parts A, B, C, and D: 2. a. Participants must be at least 18 years of age and no more than 60 years of age at the Screening

Exclusion Criteria

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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)
Masking Description
Double-blind (investigator- and subject-blinded)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part A
SAD Study in Healthy Adults
  • Drug: ORX489 Tablets
    ORX489 Tablets
  • Other: Placebo Tablets
    Placebo Tablets
Experimental
Part B
Food-effect Evaluation in Healthy Adults
  • Drug: ORX489 Tablets
    ORX489 Tablets
Experimental
Part C
MAD Study in Healthy Adults
  • Drug: ORX489 Tablets
    ORX489 Tablets
  • Other: Placebo Tablets
    Placebo Tablets
Experimental
Part D
SAD Study in Acutely Sleep-Deprived Healthy Adults
  • Drug: ORX489 Tablets
    ORX489 Tablets
  • Other: Placebo Tablets
    Placebo Tablets

Recruiting Locations

Celerion
Lincoln 5072006, Nebraska 5073708 68502

More Details

Status
Recruiting
Sponsor
Centessa Pharmaceuticals (UK) Limited

Study Contact

ORX489 Centessa Program Lead ORX489 Centessa Program Lead
617-468-5770
ORX489-101study@centessa.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.