A Study to Evaluate the Safety, Tolerability, and PK in Healthy Volunteers and HCV Genotype 1 Infected Patients

Launched by TAIGEN BIOTECHNOLOGY CO., LTD. · Jan 29, 2012

Keywords

ClinConnect 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.

Gender

ALL

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