A Phase I/IIa Study Assessing Single and Multiple Doses of HCV Protease Inhibitor IDX320 in Healthy and Genotype 1 HCV-Infected Subjects

• Conditions: Healthy Volunteer and Genotype 1 HCV infection- in Poland only Genotype 1 HCV infected; MedDRA version: 12.1Level: LLTClassification code 10008912Term: Chronic hepatitis C

• Registration Number: EUCTR2009-018079-15-PL
• Lead Sponsor: Idenix Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

1.18-65 years of age, inclusive (or the legal age of consent per local regulations).
2.Body Mass Index (BMI) 18-35 kg/m2
3.Male subjects must have agreed to use a consistent form of an acceptable double-barrier method of birth control from first dose through at least 90 days after the last dose of the study drug.
4.Subject must have agreed not to donate sperm from the first dose through 90 days after the last dose of study drug.
5.Agrees not to consume grapefruit juice within 48 hours of reporting to the clinic on Day -1 through the end of the study.
6.Pulse = 40 BPM, systolic blood pressure = 95 mmHg and QTcF interval = 450 ms at screening and Day -1.
7.Subject is, in the opinion of the investigator, willing and able to comply with the study drug regimen and all other study requirements.
8.Subject has provided written informed consent to participate in the study.
Part A Specific - N/A for Poland

Part C and D Specific (must also meet the following)
9.HCV treatment-naïve – subject must have not received prior antiviral treatment for hepatitis C infection.
10.Male or female subjects may be included. If female, subject must be of non-childbearing potential. Non-childbearing potential is defined as one of the following:
•Post-menopausal, defined as amenorrheic for at least 2 years and serum FSH level = 27 IU/L at screening.
•A documented hysterectomy, bilateral oophorectomy or bilateral tubal ligation at least 6 months prior to study initiation.
11. Documented clinical history compatible with chronic hepatitis C, including any one of the following:
•anti-HCV antibody positive at least six months prior to screening or dosing OR
•HCV RNA present in plasma by a sensitive and specific assay at least six months prior to screening or dosing OR
•Histologic evidence of chronic hepatitis C infection (Note: Subjects with cirrhosis are excluded, see exclusion #19.)
12.Plasma HCV RNA = 5 log10 IU/mL at screening.
13.HCV genotype 1 by HCV genotyping performed at screening.

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

1.Co-infected with hepatitis B virus (HBV, HBsAg positive) and/or human immunodeficiency virus (HIV).
2.Donated blood or had significant blood loss 60 days prior to dosing.
3.Use of alcohol and/or drugs that could interfere with adherence to study requirements as judged by the investigator. This includes drugs given for therapeutic reasons.
4.Positive screen result for drugs of abuse (except THC) or alcohol on Day –1, provided the positive test is not detemined to be a false positive on confirmation testing or due to medically indicated prescription drugs
5.Concomitant use of any known major inhibitor or inducer of cytochrome P450 3A4 (CYP 3A4). A washout period of at least 5 half-lives of the CYP 3A4 drug must be observed prior to study drug dosing, if the investigator feels that the drug can be safely discontinued or substituted for the duration of the study.
6.Use of other investigational drugs within 60 days of dosing, or plans to enroll in another clinical trial of an investigational agent while participating in the present study.
7.Subject with intestinal malabsorption (e.g., structural defects, digestive failure or enzyme deficiencies with the exception of lactose intolerance).
8.Subject with known allergy to the study medication or any of its components.
9.Clinically significant abnormal ECG at screening or Day -1.
10.Serum creatinine > ULN
11.Estimated glomerular filtration rate (GFR) < 60 mL/min/1.73 m2 as estimated by the MDRD formula.
PART A Specific - N/A for Poland
PART B Specific - N/A for Poland
PART C and D Specific (following also excluded)
12.Subject is pregnant or breastfeeding. Women must have a negative serum beta-human chorionic gonadotropin (ß-HCG) at screening and Day -1.
13.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.
14.Prior clinical or histological evidence of cirrhosis (e.g. Metavir 4 or Ishak 6).
15.History of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC.
16.Active clinically significant diseases including:
•Primary or secondary causes of liver disease (other than hepatitis C).
•Malignant disease or suspicion or history of malignant disease within previous 5 years (except for adequately treated basal cell carcinoma)
•Diabetes mellitus requiring treatment with medication
•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.
17. Previously received any other experimental direct-acting antiviral agents targeting the hepatits C virus
18. Requires frequent or prolonged use of systemic corticosteroids or other immunosuppressive drugs. Topical or inhaled corticosteroids are pemitted
19. Abnormal values at screening or Day -1:
- ALT or AST> 5 x ULN
- any other laboratory abnormality that is considered to be clinically significant by the Principal Investigator

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified