ORX142 in healthy adults aged 18–80

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 study gives single and multiple oral doses of ORX142 or matching placebo to healthy adult volunteers to characterize safety, tolerability, and pharmacokinetics. Most study parts enroll adults 18–55, with a separate older cohort enrolling ages 60–80 in Part D. Participants are screened to exclude significant medical or sleep disorders and seizure risk, and will undergo clinical assessments, safety monitoring, and blood sampling for drug levels. The study is conducted at three U.S. sites in Nebraska, New Jersey, and New York.

Why it matters

Who can join: the full rules

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.

Where it's running

• Site #1
  Lincoln, Nebraska, United States Recruiting
• Site #2
  Eatontown, New Jersey, United States Recruiting
• Site #3
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: ORX142 Centessa Program Lead
• Email: ORX142-0101study@centessa.com
• Phone: 617-468-5770

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.