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

T

TaiGen Biotechnology

Status and phase

Completed
Phase 1

Conditions

Healthy
Hepatitis C, Chronic

Treatments

Drug: placebo
Drug: TG-2349

Study type

Interventional

Funder types

Industry

Identifiers

NCT01523990
TG-2349-01

Details and patient eligibility

About

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

135 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy 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:

  • At least 1 year post menopausal, or
  • Surgically sterile, or
  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Quadruple Blind

135 participants in 27 patient groups, including a placebo group

Panel I (TG-2349)
Experimental group
Description:
Sequential single oral dose taken by healthy East and Caucasian volunteers from 50 mg (fasted) to 50 mg (fed) of TG-2349 with 1 week follow-up after each dosage. A washout period of at least 10 days between the 1st and the 2nd dose is required.
Treatment:
Drug: TG-2349
Panel I (placebo)
Placebo Comparator group
Description:
Sequential single oral dose taken by healthy East and Caucasian volunteers from 50 mg (fasted) to 50 mg (fed) of placebo with 1 week follow-up after each dosage. A washout period of at least 10 days between the 1st and the 2nd dose is required.
Treatment:
Drug: placebo
Panel II (TG-2349)
Experimental group
Description:
Sequential single oral dose taken by healthy East and Caucasian volunteers from 100 mg (fasted) to 100 mg (fed) of TG-2349 with 1 week follow-up after each dosage. A washout period of at least 10 days between the 1st and the 2nd dose is required.
Treatment:
Drug: TG-2349
Panel II (placebo)
Placebo Comparator group
Description:
Sequential single oral dose taken by healthy East and Caucasian volunteers from 100 mg (fasted) to 100 mg (fed) of placebo with 1 week follow-up after each dosage. A washout period of at least 10 days between the 1st and the 2nd dose is required.
Treatment:
Drug: placebo
Panel III (TG-2349)
Experimental group
Description:
Sequential single oral dose taken by healthy East and Caucasian volunteers from 200 mg (fasted or fed) to 400 mg (fasted or fed) of TG-2349 with 1 week follow-up after each dosage. A washout period of at least 10 days between the 1st and the 2nd dose is required.
Treatment:
Drug: TG-2349
Panel III (placebo)
Placebo Comparator group
Description:
Sequential single oral dose taken by healthy East and Caucasian volunteers from 200 mg (fasted or fed) to 400 mg (fasted or fed) of placebo with 1 week follow-up after each dosage. A washout period of at least 10 days between the 1st and the 2nd dose is required.
Treatment:
Drug: placebo
Panel IV (TG-2349)
Experimental group
Description:
Sequential single oral dose taken by healthy East and Caucasian volunteers from 600 mg (fasted or fed) to 800 mg (fasted or fed) of TG-2349 with 1 week follow-up after each dosage. A washout period of at least 10 days between the 1st and the 2nd dose is required.
Treatment:
Drug: TG-2349
Panel IV (placebo)
Placebo Comparator group
Description:
Sequential single oral dose taken by healthy East and Caucasian volunteers from 600 mg (fasted or fed) to 800 mg (fasted or fed) of placebo with 1 week follow-up after each dosage. A washout period of at least 10 days between the 1st and the 2nd dose is required.
Treatment:
Drug: placebo
Panel V (TG-2349)
Experimental group
Description:
Oral dose taken once daily for 5 consecutive days at dose level of 100 mg taken by healthy East and Caucasian volunteers .
Treatment:
Drug: TG-2349
Panel V (placebo)
Placebo Comparator group
Description:
Oral dose taken once daily for 5 consecutive days at dose level of 100 mg taken by healthy East and Caucasian volunteers .
Treatment:
Drug: placebo
Panel VI (TG-2349)
Experimental group
Description:
Oral dose taken once daily for 5 consecutive days at dose level of 200 mg taken by healthy East and Caucasian volunteers .
Treatment:
Drug: TG-2349
Panel VI (placebo)
Placebo Comparator group
Description:
Oral dose taken once daily for 5 consecutive days at dose level of 200 mg taken by healthy East and Caucasian volunteers .
Treatment:
Drug: placebo
Panel VII (TG-2349)
Experimental group
Description:
Oral dose taken once daily for 5 consecutive days at dose level of 400 mg taken by healthy East and Caucasian volunteers .
Treatment:
Drug: TG-2349
Panel VII (placebo)
Placebo Comparator group
Description:
Oral dose taken once daily for 5 consecutive days at dose level of 400 mg taken by healthy East and Caucasian volunteers .
Treatment:
Drug: placebo
Panel VIII (TG-2349)
Experimental group
Description:
Oral dose taken once daily for 5 consecutive days at dose level of 600 mg taken by healthy East and Caucasian volunteers .
Treatment:
Drug: TG-2349
Panel VIII (placebo)
Placebo Comparator group
Description:
Oral dose taken once daily for 5 consecutive days at dose level of 600 mg taken by healthy East and Caucasian volunteers .
Treatment:
Drug: placebo
Panel IX (TG-2349)
Experimental group
Description:
Oral dose taken once daily for 3 consecutive days at dose level of 200 mg (fed) taken by HCV genotype 1 (including subtypes 1a or 1b or mixed 1a/1b) infected patients.
Treatment:
Drug: TG-2349
Panel IX (placebo)
Placebo Comparator group
Description:
Oral dose taken once daily for 3 consecutive days at dose level of 200 mg (fed) taken by HCV genotype 1 (including subtypes 1a or 1b or mixed 1a/1b) infected patients.
Treatment:
Drug: placebo
Panel X (TG-2349)
Experimental group
Description:
Oral dose taken once daily for 3 consecutive days at dose level of 400 mg (fed) taken by HCV genotype 1 (including subtypes 1a or 1b or mixed 1a/1b) infected patients.
Treatment:
Drug: TG-2349
Panel X (placebo)
Placebo Comparator group
Description:
Oral dose taken once daily for 3 consecutive days at dose level of 400 mg (fed) taken by HCV genotype 1 (including subtypes 1a or 1b or mixed 1a/1b) infected patients.
Treatment:
Drug: placebo
Panel XI (TG-2349)
Experimental group
Description:
Oral dose taken once daily for 3 consecutive days at dose level of 600 mg (fed) taken by HCV genotype 1 (including subtypes 1a or 1b or mixed 1a/1b) infected patients.
Treatment:
Drug: TG-2349
Panel XI (placebo)
Placebo Comparator group
Description:
Oral dose taken once daily for 3 consecutive days at dose level of 600 mg (fed) taken by HCV genotype 1 (including subtypes 1a or 1b or mixed 1a/1b) infected patients.
Treatment:
Drug: placebo
Panel XII (TG-2349)
Experimental group
Description:
Oral dose taken once daily for 3 consecutive days at dose level of 600 mg (fed) taken by HCV genotype 2 infected, treatment-naive patients.
Treatment:
Drug: TG-2349
Panel XIII (TG-2349)
Experimental group
Description:
Oral dose taken once daily for 3 consecutive days at dose level of 600 mg (fed) taken by HCV genotype 3 infected, treatment-naive patients.
Treatment:
Drug: TG-2349
Panel XIV (TG-2349)
Experimental group
Description:
Oral dose taken once daily for 3 consecutive days at dose level of 600 mg (fed) taken by HCV genotype 4 infected, treatment-naive patients.
Treatment:
Drug: TG-2349
Panel XV (TG-2349)
Experimental group
Description:
Oral dose taken once daily for 3 consecutive days at dose level of 600 mg (fed) taken by HCV genotype 5 infected, treatment-naive patients.
Treatment:
Drug: TG-2349
Panel XVI (TG-2349)
Experimental group
Description:
Oral dose taken once daily for 3 consecutive days at dose level of 600 mg (fed) taken by HCV genotype 6 infected, treatment-naive patients.
Treatment:
Drug: TG-2349

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Data sourced from clinicaltrials.gov

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