Health TrialsbyHealthPanel

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

ConditionExcessive Daytime Sleepiness
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCentessa Pharmaceuticals (UK) Limited

About this trial

Characterize the safety, tolerability and pharmacokinetics of ORX142 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.

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

  • ORX142 Tablets

    Drug

    ORX142 Tablets

  • Placebo Tablets

    Other intervention

    Placebo Tablets

Treatment groups

208 Participants
are divided into 5 treatment groups
Group A: Part A: SAD Study in Healthy AdultsExperimental treatment 2 interventions
Group B: Part B: Food-effect Evaluation in Healthy AdultsExperimental treatment 1 intervention
Group C: Part C: MAD Study in Healthy AdultsExperimental treatment 2 interventions
Group D: Part D: Evaluation of a Single Dose in Healthy Older AdultsExperimental treatment 2 interventions
Group E: Part E: PoC Study in Acutely Sleep-deprived Healthy AdultsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Safety and Tolerability as assessed by AEs and SAEs

Time frame
From enrollment to the Follow-Up Visit 13 days post-discharge
2

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

Safety and Tolerability as assessed by AEs and SAEs

Time frame
From enrollment to the Follow-Up Visit 13 days post-discharge
3

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

Safety and Tolerability as assessed by AEs and SAEs

Time frame
From enrollment to the Follow-Up Visit 13 days post-discharge
4

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

Safety and Tolerability as assessed by AEs and SAEs

Time frame
From enrollment to the Follow-Up Visit 13 days post-discharge

Secondary outcomes

1

Cmax: Maximum Observed Plasma Concentration for ORX142 in subjects receiving ORX142

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

Tmax: Time of Maximum Concentration for ORX142 in subjects receiving ORX142

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 ORX142 in subjects receiving ORX142

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 ORX142 to decrease by half in subjects receiving ORX142

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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