This study is an open-label, 3-way crossover randomized study in adult healthy volunteers to evaluate the relative bioavailability of TT-00420 tablet and capsule formulations and to evaluate food effect on the pharmacokinetics of TT-00420 tablet.
Subjects will be randomized to one of three treatment sequences. Each sequence will contain up to 8 subjects. In each treatment sequence, subjects undergo a baseline/screening period, three treatment periods, and a follow-up visit. Subjects will be administered a single dose of TT-00420 on Day 1 of either TT-00420 tablet under fed condition, TT-00420 tablet under fasting condition, or capsule under fasting condition and crossed over after at least a 14-day washout period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
24
TT-00420 capsule formulation, administered orally
TT-00420 tablet formulation, administered orally
Pharmaron CPC
Baltimore, Maryland, United States
Area under the curve (AUC0-∞) of TT-00420
Blood samples will be collected at indicated time points for pharmacokinetic analysis of TT-00420.
Time frame: From pre-dose up to 240 hours post-dose each period (each period is 14 days)
Area under the curve (AUC0-t) of TT-00420
Blood samples will be collected at indicated time points for pharmacokinetic analysis of TT-00420.
Time frame: From pre-dose up to 240 hours post-dose each period (each period is 14 days)
Maximum observed concentration (Cmax) of TT-00420
Blood samples will be collected at indicated time points for pharmacokinetic analysis of TT-00420.
Time frame: From pre-dose up to 240 hours post-dose each period (each period is 14 days)
Number of participants with adverse events (AEs)
Time frame: From admission up to 10 days following discharge
Incidence of abnormal physical examinations
Time frame: At baseline and from admission to discharge, up to 12 days per period (each period is 14 days)
Incidence of abnormal clinical laboratory tests
Time frame: At baseline and from admission to discharge, up to 12 days per period (each period is 14 days)
Incidence of abnormal vital signs
Time frame: At baseline and from admission to discharge, up to 12 days per period (each period is 14 days)
Incidence of abnormal weight
Time frame: At baseline and from admission to discharge, up to 12 days per period (each period is 14 days)
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Incidence of abnormal 12-lead electrocardiogram
Time frame: At baseline and from admission to discharge, up to 12 days per period (each period is 14 days)
Half life (t1/2) of TT-00420
Blood samples will be collected at indicated time points for pharmacokinetic analysis of TT-00420.
Time frame: From pre-dose up to 240 hours post-dose each period (each period is 14 days)
Time of maximum concentration (tmax) of TT-00420
Blood samples will be collected at indicated time points for pharmacokinetic analysis of TT-00420.
Time frame: From pre-dose up to 240 hours post-dose each period (each period is 14 days)
Volume of distribution (Vd/F) of TT-00420
Blood samples will be collected at indicated time points for pharmacokinetic analysis of TT-00420.
Time frame: From pre-dose up to 240 hours post-dose each period (each period is 14 days)
Clearance (CL/F) of TT-00420
Blood samples will be collected at indicated time points for pharmacokinetic analysis of TT-00420.
Time frame: From pre-dose up to 240 hours post-dose each period (each period is 14 days)