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Clinical Trials/EUCTR2008-005558-19-AT
EUCTR2008-005558-19-ATActive, not recruitingNot Applicable

A Phase I/II, Double-Blind, Dose-Escalation Study to Evaluate the Safety and Antiviral Activity of IDX184 in Treatment-Naïve Subjects Infected with Genotype 1 Chronic Hepatitis C

Idenix Pharmaceuticals, Inc.0 sites40 target enrollmentStarted: December 17, 2008Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
40
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •To participate in the study, subjects must meet all of the following inclusion criteria:
  • •1. Subject is 18-65 years of age, inclusive (or the legal age of consent per
  • •local regulations).
  • •2. Female subjects of both childbearing potential and non-childbearing
  • •potential may be included, unless the local regulatory authority
  • •requires that only females of non-childbearing potential be included.
  • •Non-childbearing potential is defined as one of the following:
  • •Post-menopausal, defined as amenorrheic for at least 2 years
  • •and have a serum FSH level = 40 IU/L at screening
  • •Have had a documented hysterectomy, bilateral oophorectomy
  • •or bilateral tubal ligation at least 6 months prior to study initiation
  • •3. All female subjects of childbearing potential must have agreed to use a
  • •consistent form of an acceptable double-barrier method of birth control
  • •(such as a condom plus spermicide) from screening through at least
  • •30 days after the last dose of the study drug. All male subjects of
  • •childbearing potential must have agreed to use a consistent form of an
  • •acceptable double-barrier method of birth control (such as a condom
  • •plus spermicide) from first dose through at least 90 days after the last
  • •dose of the study drug.
  • •4. Male subjects must have agreed not to donate sperm from the first
  • •dose through 90 days after the last dose of study drug.
  • •5. Documented clinical history compatible with chronic hepatitis C,
  • •including presence of HCV RNA in the plasma at least six months
  • •prior to screening and liver biopsy within 24 months of screening or
  • •dosing with histology consistent with chronic hepatitis C infection.
  • •6. Plasma HCV RNA = 5 log10 IU/mL at screening.
  • •7. HCV genotype 1 (no mixed genotypes), by HCV genotyping performed
  • •at screening.
  • •8. Pulse = 45 BPM, systolic blood pressure = 90 mmHg and QTc interval
  • •= 430 ms for males or = 450 ms for females, at screening and prior to
  • •dosing on Day 1.
  • •9. Subject is, in the opinion of the investigator, willing and able to comply
  • •with the study drug regimen and all other study requirements; subject
  • •has provided written informed consent to participate in the study.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • •Subjects will be excluded from the study if they meet any of the following exclusion criteria:
  • •1. Subject is pregnant or breastfeeding. Women must have a negative serum beta-human chorionic gonadotropin (ß-HCG) at screening and a negative urine pregnancy test prior to the first dose of study medication on Day 1.
  • •2. Body Mass Index (BMI) > 32.
  • •3. Co-infected with hepatitis B virus (HBV, HBsAg positive) and/or human
  • •immunodeficiency virus (HIV).
  • •4. History or signs of decompensated liver disease: Child-Pugh class B or C, ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or other clinical signs of portal hypertension or hepatic insufficiency.
  • •5. History of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC, such as suspicious foci on imaging studies or elevated serum alpha-fetoprotein (AFP) level (>50 ng/mL). In subjects with such findings, HCC should be ruled-out prior to
  • •randomization.
  • •6. Has one or more additional known primary or secondary causes of liver disease, other than hepatitis C (e.g., alcoholism, autoimmune hepatitis, nonalcoholic steatohepatitis, drugrelated liver disease, malignancy with hepatic involvement, hemochromatosis, alpha-1 antitrypsin deficiency, Wilson’s Disease, Gilbert’s syndrome, Dubin-Johnson syndrome, other congenital or metabolic conditions affecting the liver, etc).
  • •7. Abnormal renal function as evidenced by a screening serum creatinine or BUN value > upper limit of normal or a screening creatinine clearance (CLCR) < 80 mL/min as estimated by the Cockcroft-Gault formula
  • •8. History of other clinically significant diseases including:
  • •Acute liver or biliary injury due to drugs, ingested toxins (e.g. mushrooms), other
  • •viral hepatitis (e.g. hepatitis A), gallstones or other etiologies
  • •Active malignant disease or suspicion or history of malignant disease within previous 5 years (except for adequately treated basal cell carcinoma)
  • •History of organ transplants, except for corneal or hair transplant
  • •Uncontrolled depressive illness
  • •Uncontrolled hyperthyroidism or autoimmune thyroidopathy. Thyroid function
  • •(thyroid stimulating hormone (TSH), T4 and T3) must be normal at screening.
  • •Uncontrolled hypertension
  • •Type 1 diabetes mellitus or Type 2 diabetes being treated with oral hypoglycemic
  • •Neurological disease
  • •Acute or chronic pancreatitis
  • •Active infections including tuberculosis or opportunistic infection
  • •Intestinal malabsorption (e.g., structural defects, digestive failure, enzyme
  • •deficiencies, etc.)
  • •Cardiac disease, clinically significant arrhythmia, family history of congenital heart
  • •disease, family history of prolonged QT, or family history of sudden death of
  • •unknown etiology
  • •Any other condition that, in the opinion of the Principal Investigator, would
  • •jeopardize the safety of the subject or impact the validity of the study results
  • •9. Currently abusing alcohol or illicit drugs, or unwilling to abstain from the use of alcohol from 72 hours prior to dosing through to the end of the study. For the purposes of this study, alcohol abuse is arbitrarily defined as frequent consumption of alcoholic beverages with an average daily intake of more than 40 g of ethanol.
  • •10. Received prior antiviral treatment for hepatitis C infection.
  • •11. Currently receiving methadone, buprenorphine or other drugs for the treatment of opioid addiction.
  • •12. Use of any known inhibitor and/or inducer of cytochrome P450 3A4 (CYP 3A4) within 30 days of dosing.

Investigators

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