A Single-center, Open-label, Single-dose, Three-period, Fixed Sequence Study to Evaluate the Relative Bioavailability of a New Formulation of NPT 2042 Soft-Gelatin Capsules
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
In Period 1 Day 1, participants will receive Formulation 1 in a fasted state (Treatment A).
Following a 3-day wash out, in Period 2 Day 1, participants will receive Formulation 2 in a fasted state (Treatment B).
Following a 4-day wash out, in Period 3 Day 1, participants will receive Formulation 2 in a fasted state with co-administered agent (Treatment C).
Celerion
Lincoln, Nebraska, United States
To estimate the single dose pharmacokinetic parameters for each NPT 2042 formulation in healthy participants following each treatment.
Plasma NPT 2042 PK endpoints including the Cmax (NPT 2042 only).
Time frame: Baseline (Day -1) as compared to Tx. period 1 (Day 1), Tx. Period 2 (Day 4), and Tx. Period 3 (Day 7)
To estimate the single dose pharmacokinetic parameters for each NPT 2042 formulation in healthy participants following each treatment.
Plasma NPT 2042 PK endpoints including the Tmax (NPT 2042 only).
Time frame: Baseline (Day -1) as compared to Tx. period 1 (Day 1), Tx. Period 2 (Day 4), and Tx. Period 3 (Day 7)
To estimate the single dose pharmacokinetic parameters for each NPT 2042 formulation in healthy participants following each treatment.
Plasma NPT 2042 PK endpoints including the t½ (NPT 2042 only).
Time frame: Baseline (Day -1) as compared to Tx. period 1 (Day 1), Tx. Period 2 (Day 4), and Tx. Period 3 (Day 7)
To estimate the single dose pharmacokinetic parameters for each NPT 2042 formulation in healthy participants following each treatment.
Plasma NPT 2042 PK endpoints including the AUClast (NPT 2042 only).
Time frame: Baseline (Day -1) as compared to Tx. period 1 (Day 1), Tx. Period 2 (Day 4), and Tx. Period 3 (Day 7)
To estimate the single dose pharmacokinetic parameters for each NPT 2042 formulation in healthy participants following each treatment.
Plasma NPT 2042 PK endpoints including the AUCinf (NPT 2042 only).
Time frame: Baseline (Day -1) as compared to Tx. period 1 (Day 1), Tx. Period 2 (Day 4), and Tx. Period 3 (Day 7)
To estimate the single dose pharmacokinetic parameters for each NPT 2042 formulation in healthy participants following each treatment.
Plasma NPT 2042 PK endpoints including the CL/F (NPT 2042 only).
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Time frame: Baseline (Day -1) as compared to Tx. period 1 (Day 1), Tx. Period 2 (Day 4), and Tx. Period 3 (Day 7)
To calculate the Frel and 90% confidence intervals for Formulation 1 (Reference) vs Formulation 2 (Test) both administered in a fasted state.
The Frel calculations will be based on Cmax and AUCinf values for NPT 2042.
Time frame: Baseline (Day -1) as compared to Tx. period 1 (Day 1) and Tx. Period 2 (Day 4)