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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014