Study to Evaluate the PK, Relative Bioavailability and Safety of TG-2349 With Single Oral Dose Under Fed Condition in Healthy 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.

Inclusion Criteria at Screening

1. East Asian or Caucasian subjects, male or female, and 18 to 40 years of age inclusive

2. Body mass index (BMI) in the range of 19.0 to 30.0 kg/m2 and body weight ≥ 50 kg
inclusive

3. In general good physical and mental health status on the basis of a medical history
review, medical evaluation including vital signs and physical examination, 12-lead
ECG, and laboratory results at screening

4. For females, one of the following criteria must be fulfilled:

(1)At least 1 year post menopausal, or (2)Surgically sterile, or (3)Willing to use a
double-barrier method (intrauterine device [IUD] plus condom, spermicidal gel plus condom)
of contraception from screening until 30 days after the last dose of study drug; 5.Males
must be willing to use a reliable form of contraception (use of a condom or a partner
fulfilling the above criteria) from screening until 30 days after the last dose of study
drug 6.Willing to abstain from caffeine- or xanthine-containing beverages (including
coffee and tea), alcohol, grapefruit juice, and Seville oranges during the stay-on-site
period 7.Willing and able to provide written informed consent

Exclusion Criteria at Screening

1. Positive serological test for IgM anti-HAV antibody, HbsAg, or anti-HCV antibody at
screening

2. Positive ELISA test for HIV-1 or HIV-2 at screening

3. Any of the following abnormal laboratory values at screening: Hemoglobin (Hb)
<12.0g/dL for women and <13.0g/dL for men, white blood cell count (WBC) <3,000
cells/mm3, absolute neutrophil count <1,500 cells/mm3, platelet count <100,000
cells/mm3, serum creatinine ≥ 2 mg/dL, ALT or AST levels ≥ 2 xULN, total bilirubin ≥
1.5 xULN, INR (International Normalized Ratios for prothrombin time) ≥1.5 xULN

4. Any abnormal laboratory values that are considered clinically significant by the
Investigator at screening

5. QTcF greater than 450 msec for females and 430 msec for males at screening

6. History of renal, hepatic impairment, stomach or intestinal surgery or resection,
malabsorption syndrome

7. History of seizures, epilepsy, cardiovascular, diabetes, or cancer (except basal cell
carcinoma)

8. History or family history of prolonged QT interval or family history of sudden
cardiac death at a young age (< 30 years )

9. History of drug allergy or hypersensitivity, especially to sulfa drugs

10. History or evidence of abuse of alcohol, barbiturate, amphetamine, recreational, or
narcotic drug use within 6 months prior to first dose of study drug administration

11. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for
treatment of a psychiatric illness, or who have any history of suicide attempt or
depression

12. Anemia or blood/plasma donation within 30 days prior to first dose of study drug
administration

13. Pregnant or breast-feeding

14. Use of tobacco or nicotine-containing products within 30 days prior to first dose of
study drug administration

15. Use of concomitant medication, including herbal remedies and dietary supplements
(except for paracetamol/acetaminophen, ibuprofen, and hormonal contraceptives) within
14 days prior to first dose of study drug administration

16. Received any other investigational drug within 30 days prior to first dose of study
drug administration

Exclusion Criteria at the First Admission

1. Any of the following abnormal laboratory values at admission: Hb <12.0g/dL for women
and <13.0g/dL for men, WBC <3,000 cells/mm3, absolute neutrophil count <1,500
cells/mm3, platelet count <100,000 cells/mm3, serum creatinine ≥ 2 mg/dL, ALT or AST
levels ≥ 2 xULN, total bilirubin ≥ 1.5 xULN, INR ≥ 1.5 xULN

2. Any abnormal laboratory values that are considered clinically significant by the
Investigator at admission

3. Any clinically significant abnormality on 12-lead ECG or a QTcF greater than 450 msec
for females and 430 msec for males at admission

4. Positive urine drug screen or breath alcohol test at admission

5. If female, positive serum pregnancy test at admission

6. Acute illness within 2 weeks prior to dosing, unless approved by the Sponsor's
Medical Monitor