Characterize the safety, tolerability and pharmacokinetics of ORX142 following single and multiple doses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
208
ORX142 Tablets
Placebo Tablets
Site #1
Lincoln, Nebraska, United States
RECRUITINGSite #2
Eatontown, New Jersey, United States
RECRUITINGSite #3
New York, New York, United States
RECRUITINGPart 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
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
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
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
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
Safety and Tolerability as assessed by AEs and SAEs
Time frame: From enrollment to the Follow-Up Visit 13 days post-discharge
Cmax: Maximum Observed Plasma Concentration for ORX142 in subjects receiving ORX142
Time frame: Pre-dose and multiple post-dose timepoints, up to 48 hours
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Tmax: Time of Maximum Concentration for ORX142 in subjects receiving ORX142
Time frame: Pre-dose and multiple post-dose timepoints, up to 48 hours
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
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
Cmax: Maximum Observed Plasma Concentration for ORX142 in subjects receiving ORX142 in the fasted and fed state.
Time frame: Pre-dose and multiple post-dose timepoints, up to 48 hours
Tmax: Time of Maximum Concentration for ORX142 in subjects receiving ORX142 in the fast and fed state
Time frame: Pre-dose and multiple post-dose timepoints, up to 48 hours
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 in the fast and fed state
Time frame: Pre-dose and multiple post-dose timepoints, up to 48 hours
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 in the fast and fed state
Time frame: Pre-dose and multiple post-dose timepoints, up to 48 hours
Mean sleep latency in the Maintenance of Wakefulness Test (MWT) for ORX142 versus placebo.
Time frame: Part E: Day 2
Karolinska Sleepiness Scale score for ORX142 versus placebo
Time frame: Part E: Day 1-2