RecruitingPhase 1

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

United States208 participantsStarted 2025-06-30

Plain-language summary

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

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Healthy males or females as determined by assessments at the Screening Visit.
✓. For Part D:

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.

What they're measuring

Part A: Incidence and severity of Treatment-Emergent Adverse Events of oral single ascending doses of ORX142 in healthy adult subjects

Timeframe: From enrollment to the Follow-Up Visit 13 days post-discharge

Part B: Incidence and severity of Treatment-Emergent Adverse Events of oral single ascending doses of ORX142 in the fasted and fed states

Timeframe: From enrollment to the Follow-Up Visit 13 days post-discharge

Part C: Incidence and severity of Treatment-Emergent Adverse Events of oral multiple ascending doses of ORX142 in healthy adult subjects

Timeframe: From enrollment to the Follow-Up Visit 13 days post-discharge

Part D: Incidence and severity of Treatment-Emergent Adverse Events of oral single oral doses of ORX142 in healthy older adult subjects

Timeframe: From enrollment to the Follow-Up Visit 13 days post-discharge

Part E: Incidence and severity of Treatment-Emergent Adverse Events of oral of single oral doses of ORX142 in acutely sleep-deprived healthy adult subjects

Timeframe: From enrollment to the Follow-Up Visit 13 days post-discharge

Trial details

NCT IDNCT07082829

SponsorCentessa Pharmaceuticals (UK) Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-15

Contact for this trial

ORX142 Centessa Program Lead

617-468-5770 ORX142-0101study@centessa.com

View on ClinicalTrials.gov More Excessive Daytime Sleepiness trials

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Healthy males or females as determined by assessments at the Screening Visit.
✓. For Part D:

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.