The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) profile of different doses of TG-2349 (Furaprevir capsule) in healthy Chinese volunteers.
This study is to evaluate the safety, tolerability, and pharmacokinetics (PK) profile in healthy Chinese volunteers with single or multiple ascending oral doses of TG-2349 (Furaprevir capsule). The study is separated into two parts, part A and part B. Part A:To evaluate the safety, tolerability, and PK profile of single ascending oral dose (100 mg, 200 mg, 400 mg, and 600 mg) of TG-2349 in healthy Chinese volunteers. Part B:To evaluate the safety, tolerability, and PK profile of multiple ascending oral doses (200 mg, 400 mg, and 600 mg) of TG-2349 for five days in healthy Chinese volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
64
There are four doses in this part, 100 mg, 200 mg, 400 mg, and 600 mg. Each subject will receive the sample once by oral administration.
There are three doses in this part, 200 mg, 400 mg, and 600 mg. Each subject will be allocated into one dosing regimen and receive the sample once daily for 5 consecutive days by oral administration.
Each subject will receive the sample once by oral administration.
Xiangya Hospital Central South University
Changsha, Hunan, China
Cmax (Maximum Plasma Concentration)
Maximum Plasma Concentration
Time frame: 10 days
Tmax (Time at Which Maximum Plasma Concentration is Observed)
Time at Which Maximum Plasma Concentration is Observed
Time frame: 10 days
AUC (Area Under the Plasma Concentration)
Area Under the Plasma Concentration
Time frame: 10 days
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
CTCAE v4.0
Time frame: 10 days
12-lead ECG (electrocardiogram)
Time frame: 10 days
blood pressure (mmHg)
Vital signs
Time frame: 10 days
pulse (beats/ min)
Vital signs
Time frame: 10 days
respiratory rate (breaths/ min)
Vital signs
Time frame: 10 days
body temperature (oC)
Vital signs
Time frame: 10 days
General Appearance Physical examination
Physical examination
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Each subject will be allocated into one dosing regimen and receive the sample once daily for 5 consecutive days by oral administration.
Time frame: 10 days
Skin Physical examination
Physical examination
Time frame: 10 days
Head and Neck Physical examination
Physical examination
Time frame: 10 days
Chest region Physical examination
Physical examination
Time frame: 10 days
Abdominal region Physical examination
Physical examination
Time frame: 10 days
Back region Physical examination
Physical examination
Time frame: 10 days
Extremities Physical examination
Physical examination
Time frame: 10 days