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

This study is currently recruiting participants.
Verified June 2013 by TaiGen Biotechnology Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
TaiGen Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01523990
First received: October 13, 2011
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention Phase
Healthy
Drug: TG-2349
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study in Healthy 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

Further study details as provided by TaiGen Biotechnology Co., Ltd.:

Primary Outcome Measures:
  • Pharmacokinetics (PK) profiles of single and multiple ascending oral doses of TG-2349 in healthy East Asian and Caucasian volunteers. [ Time Frame: predose, 0,1,2,3,4,6,8,12,24,48,72, 96 hours post-dose ] [ Designated as safety issue: No ]
    Pharmacokinetics parameters include Cmax, Area Under Curve, Tmax, Ae%, and T1/2.


Secondary Outcome Measures:
  • The food effect of TG-2349 in healthy volunteers [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    The food effect will be evaluated by whether food significantly affects drug absorption and exposure by PK parameters (e.g. AUC, Cmax, Tmax, and T1/2).


Other Outcome Measures:
  • The safety and tolerability of TG-2349 [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    All adverse events will be coded according to the MedDRA dictionary, and be limited to events related or not related to study drug.


Estimated Enrollment: 120
Study Start Date: October 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 50mg Drug: TG-2349
oral
Experimental: 100mg Drug: TG-2349
oral
Experimental: 200mg Drug: TG-2349
oral
Experimental: 600mg Drug: TG-2349
oral
Placebo Comparator: placebo Drug: placebo
oral

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01523990

Contacts
Contact: Nicole Sims, DO 714-252-0700

Locations
United States, California
WCCT Recruiting
Cypress, California, United States, 90630
Contact: Nicole Sims, DO         
Sponsors and Collaborators
TaiGen Biotechnology Co., Ltd.
Investigators
Principal Investigator: Nicole Sims, DO WCCT
  More Information

No publications provided

Responsible Party: TaiGen Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT01523990     History of Changes
Other Study ID Numbers: TG-2349-01
Study First Received: October 13, 2011
Last Updated: June 17, 2013
Health Authority: United States: Institutional Review Board
Taiwan : Food and Drug Administration

ClinicalTrials.gov processed this record on April 14, 2014