1. To evaluate the pharmacokinetics (PK) and relative bioavailability of TG-2349, given as a new capsule formulation and as the original formulation of oral solution, after a single oral dose of 400 mg under fed condition in healthy volunteers. 2. To evaluate the safety and tolerability of TG-2349 in healthy volunteers. 3. To evaluate the ethnic differences in PK and safety between East Asian and Caucasian volunteers.
TG-2349 oral solution has been investigated in a phase I/IIa study (study number: TG-2349-01) in healthy volunteers and patients with chronic hepatitis C (CHC) infection. The study demonstrated that TG-2349 was safe and well-tolerated when given to healthy volunteers at single oral doses up to 800 mg, and at five-consecutive daily oral doses up to 600 mg. Co-administration of TG-2349 with food resulted in a significant increase in bioavailability, and therefore concomitant food intake with dosing is recommended. To further advance the clinical development of TG-2349, a new capsule formulation was developed to replace the current TG-2349 oral solution. The objectives of this study (study number: TG-2349-02) are to evaluate the PK and relative bioavailability of TG-2349, given as a new capsule formulation and as the original formulation of oral solution, after a single oral dose of 400 mg under fed condition in healthy volunteers, and to evaluate the safety, tolerability, and ethnic differences of the TG-2349 capsule formulation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
24
single oral dose under fed condition
single oral dose under fed condition
WCCT
Cypress, California, United States
Primary pharmacokinetic parameters: AUC0-t, AUC0-inf and Cmax
Time frame: 120 hours after administration of study drug in each session
Secondary pharmacokinetic parameters:Tmax, t1/2, CL/F, V/F and λz
Time frame: 120 hours after administration of study drug in each session
Urine pharmacokinetic parameters: Urine Ae%
Time frame: 120 hours after administration of study drug in each session
Stool pharmacokinetic parameters: Stool Ae%
Time frame: 120 hours after administration of study drug in each session
Safety parameters: Incidence and severity of AEs, changes from baseline in safety laboratory values, 12-lead ECG parameters, vital signs, and physical examination.
Time frame: approximately 7 weeks
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