A clinical pharmacology study to determine the pharmacokinetic , safety and tolerability profile and antiviral activity of multiple oral doses of A-831 in otherwise healthy male Hepatitis C carriers with compensated liver disease. - Clinical pharmacology study of A-831 in Hepatitis C carriers

• Conditions: Male Hepatitis C carriers with compensated liver disease; MedDRA version: 9.1Level: LLTClassification code 10019744Term: Hepatitis C

• Registration Number: EUCTR2007-000328-42-GB
• Lead Sponsor: Arrow Therapeutics Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 36

Inclusion Criteria

Volunteers will be males of any race aged 18-60 years with a BMI between 18 and 32 kg/m2 at the time of the screening medical

Volunteers who have given their written informed consent to participate in the study

Volunteers who are willing and able to comply with the protocol and study procedures

Volunteers who have a diagnosis of chronic hepatitis C infection (genotype Ia or 1b) confirmed by documentation of the presence of circulating hepatitis C virus by a hepatitis C PCR test with viral RNA load of = 100 000 IU/mL (by Taqman assay)

Volunteers must be in good health (other than history of Hepatitis C infection) as determined by a medical history, medical examination, electrocardiograph, serum biochemistry, haematology, urinalysis, and serology (Hepatitis B and HIV).

If previously treated for hepatitis C infection, subjects must have completed treatment at least 6 months before 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

Volunteers who have taken any prescribed systemic or topical medication, within 14 days or any over the counter medication within 7 days of the start of dosing (excluding paracetamol). Over the counter medication, which in the opinion of the Investigator will not interfere with the objectives of this study, will be permitted.

Volunteers who have donated any blood or plasma in the last 3 months, or in excess of 1100mL of blood within the 12 months preceding screening

Volunteers who have received an investigational drug within 3 months (90 days) preceding the start of dosing

Volunteers who have any significant history of drug allergies

Volunteers who have any clinically significant allergic disease (excluding non-active hayfever)

Volunteers who have a supine blood pressure, after resting for 5 min, higher than 145 mmHg for systolic, 90 mmHg for diastolic blood pressure or lower than 90 mmHg for systolic, 45 mmHg for diastolic blood pressure

Volunteers who have a supine pulse, after resting for 5 min, outside the range of 40 to 90 beats/min

Volunteers who have consumed more than 28 units of alcohol per week in the three months prior to the screening medical

Volunteers who smoke more than 10 cigarettes per day

Volunteers with, or a history of, clinically significant neurological, gastrointestinal, cardiovascular, pulmonary, metabolic, endocrine, haematological or other major disorders, excluding Hepatitis C infection.

Volunteers with a previous episode of psychosis or suicide attempt or who have been treated with antidepressant medication within the past six months.

Volunteers who, in the opinion of the Investigator have any clinically significant abnormal laboratory tests. All volunteers must have:
ALT, GGT and AST results = 5 x ULN ,
total bilirubin results = 20 µmol/L (or genotypic evidence of Gilberts syndrome)
Alkaline Phosphatase results = 3 x ULN.

Volunteers with decompensated liver disease or histological or clinical evidence of cirrhosis are excluded. Clinical evidence includes:
abnormal bilirubin
low albumin (<3.5g/dL)
low platelet count (<140,000/mm3)
clinical syndromes of decompensated liver disease at any point in the patient’s history.

Volunteers who have evidence of hepatocellular carcinoma or an alpha-fetoprotein of >50µg/mL

Volunteers who have had any surgery of the gastrointestinal tract likely to affect drug absorption

Volunteers who have had a clinically significant acute illness within 4 weeks of the start of dosing

Volunteers, who in the opinion of their general practitioner, hepatologist or the Investigator, should not participate in the study

Volunteers with confirmed positive and clinically significant drugs of abuse test

Study & Design

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