| Study Summary: |
|
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study in Healthy East Asian and
Caucasian Volunteers to Evaluate the Safety, Tolerability, and Pharmacokinetics Profiles of
Single and Multiple Ascending Oral Doses of TG-2349, and Followed by a Dose-Ranging Study in
Hepatitis C Genotype 1 Infected Patients.
|
| Criteria: |
|
Inclusion Criteria:
- East Asian or Caucasian subjects, male or female, and 18 to 65 years of age inclusive
- Body mass index (BMI) in the range of 19.0 to 30.0 kg/m2 and body weight ≥ 50 kg
inclusive
- In generally 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
- 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
- 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
- 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
- Willing and able to provide written informed consent
Exclusion Criteria:
- Positive serological test for IgM anti-HAV antibody, HBsAg or anti-HCV antibody at
screening
- Positive ELISA test for HIV-1 or HIV-2 at screening
- Any 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 x ULN, INR (International Normalized Ratios for prothrombin time) ≥ 1.5 xULN
- Any abnormal laboratory values that are considered clinically significant by the
Investigator at screening
- QTcF greater than 450 msec for females and 430 msec for males at screening
- History of renal, hepatic impairment, stomach or intestinal surgery or resection,
malabsorption syndrome
- History of seizures, epilepsy, cardiovascular, diabetes or cancer (except basal cell
carcinoma)
- History or family history of prolonged QT interval or family history of sudden
cardiac death at a young age
- History of drug allergy or hypersensitivity, especially to sulfa drugs
- 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
- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for
treatment of a psychiatric illness, or have any history of suicide attempt or
depression
- Anemia or blood/plasma donation within 30 days prior to first dose of study drug
administration
- Pregnant or breast-feeding
- Use of tobacco or nicotine-containing products within 30 days prior to first dose of
study drug administration
- 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
- Received any other investigational drug within 30 days prior to first dose of study
drug administration
|