Study NPT 2042 CL 101 is a first in human (FIH) study to evaluate the safety and pharmacokinetics (PK) of single and repeated ascending doses of NPT 2042 in healthy adult male and female subjects.
The long-term goal of this program is to develop NPT 2042 an adjunct antiseizure treatment for patients with medically intractable epilepsy. Prior to evaluating efficacy in the intended patient population, safety and pharmacokinetics of NPT 2042 will be investigated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
Soft gelatin capsules
Celerion
Lincoln, Nebraska, United States
Number of participants with adverse events
Absolute values and change from baseline after a single dose or after 7 days of repeated dosing.
Time frame: Up to 11 days
Number of participants with abnormal lab test results
Absolute values and change from baseline after a single dose or after 7 days of repeated dosing in clinical chemistry, hematology, and urinalysis.
Time frame: Up to 11 days
Number of participants with abnormal vital signs
Absolute values and change from baseline after a single dose or after 7 days of repeated dosing in vital signs (oral body temperature, respiratory rate, blood pressure, and heart rate).
Time frame: Up to 11 days
Number of participants with abnormal ECG
Absolute values and change from baseline after a single dose or after 7 days of ECG intervals.
Time frame: Up to 7 days
Pharmacokinetic Cmax
Maximum (peak) observed concentration of NPT 2042.
Time frame: 0 (predose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 30, and 36 hours postdose
Pharmacokinetic Tmax
Time to maximum observed concentrations of NPT 2042.
Time frame: 0 (predose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 30, and 36 hours postdose
Pharmacokinetic half-life (t1/2)
Time to terminal elimination half-life concentrations of NPT 2042.
Time frame: 0 (predose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 30, and 36 hours postdose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pharmacokinetic AUClast
Area under the concentration-time curve from zero to the last concentration quantifiable for NPT 2042.
Time frame: 0 (predose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 30, and 36 hours postdose
Pharmacokinetic AUCinf
Area under the plasma concentration-time curve from time zero extrapolated to infinity for NPT 2042.
Time frame: 0 (predose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 30, and 36 hours postdose
Pharmacokinetic CL/F
Apparent total plasma clearance after oral administration of NPT 2042.
Time frame: 0 (predose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 30, and 36 hours postdose
Pharmacokinetic VzF
Apparent volume of distribution during terminal elimination phase after oral administration of NPT 2042.
Time frame: 0 (predose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 30, and 36 hours postdose
Dose proportionality
Dose proportionality of NPT 2042 will be assessed using the power model.
Time frame: 0 (predose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 30, and 36 hours postdose