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

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

A Safety Study to Evaluate the Safety, Tolerability, and Pharmacokinetics in HCV Genotype 1 Infected Patients

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: TaiGen Biotechnology Co., Ltd.

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