Health TrialsbyHealthPanel

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

ConditionHealthy Adult Male and Female Volunteers
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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • ORX489 Tablets

    Drug

    ORX489 Tablets

  • Placebo Tablets

    Other intervention

    Placebo Tablets

Treatment groups

212 Participants
are divided into 4 treatment groups
Group A: Part AExperimental treatment 2 interventions
Group B: Part BExperimental treatment 1 intervention
Group C: Part CExperimental treatment 2 interventions
Group D: Part DExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Part A

Incidence and severity of Treatment-Emergent Adverse Events \[Safety and Tolerability\] as assessed by AEs and SAEs of oral single ascending doses of ORX489 in healthy adult participants.

Time frame
From enrollment to the Follow-Up Visit 7 days post-discharge
2

Part B

Incidence and severity of Treatment-Emergent Adverse Events \[Safety and Tolerability\] as assessed by AEs and SAEs of oral single ascending doses of ORX489 in the fasted and fed states

Time frame
From enrollment to the Follow-Up Visit 7 days post-discharge]
3

Part C

Incidence and severity of Treatment-Emergent Adverse Events \[Safety and Tolerability\] as assessed by AEs and SAEs of oral multiple ascending doses of ORX489 in healthy adult participants

Time frame
From enrollment to the Follow-Up Visit 7 days post-discharge]
4

Part D:

Incidence and severity of Treatment-Emergent Adverse Events \[Safety and Tolerability\] as assessed by AEs and SAEs of oral single oral doses of ORX489 in sleep-deprived healthy adult participants

Time frame
From enrollment to the Follow-Up Visit 7 days post-discharge

Secondary outcomes

1

Cmax

Maximum Observed Plasma Concentration for ORX489 in participants receiving ORX489

Time frame
Pre-dose and multiple post-dose timepoints, up to 48 hours
2

Tmax

Time of Maximum Concentration for ORX489 in participants receiving ORX489

Time frame
Pre-dose and multiple post-dose timepoints, up to 48 hours
3

AUClast

Area Under the Plasma Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration for ORX489 in participants receiving ORX489

Time frame
Pre-dose and multiple post-dose timepoints, up to 48 hours
4

T 1/2 (terminal elimination half-life)

The time required for the terminal phase blood concentration of ORX489 to decrease by half in participants receiving ORX489

Time frame
Pre-dose and multiple post-dose timepoints, up to 48 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centessa Pharmaceuticals (UK) Limited

Lead sponsor

Source ClinicalTrials.gov
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