a study to evaluate the safety, tolerability, and pk in healthy volunteers and hcv genotype 1 infected patients

Conditions: Healthy; Hepatitis C, Chronic

Summary: a safety study to evaluate the safety, tolerability, and pharmacokinetics in hcv genotype 1 infected patients

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.

Eligibility 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