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A Safety Study to Evaluate the Safety, Tolerability, and Pharmacokinetics in HCV Genotype 1 Infected Patients
Full description
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.
Enrollment
Sex
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Volunteers
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:
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
Primary purpose
Allocation
Interventional model
Masking
135 participants in 27 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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