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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorCentessa Pharmaceuticals (UK) Limited

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Treatments tested in this trial

  • ORX489 Tablets
  • Placebo Tablets

Treatment groups

212 Participants
are divided into 4 treatment groups