Male Hepatitis C carriers with compensated liver disease MedDRA version: 9.1 Level: LLT Classification code 10019744 Term: Hepatitis C
Conditions
Interventions
Product Name: A-831/Hydroxypropyl methyl cellulose in bottles
Product Code: A-831/Hydroxypropyl methyl cellulose
Pharmaceutical Form: Granules for oral suspension
Current Sponsor code: A-831
Other des
Sponsors
Arrow Therapeutics Ltd
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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 (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the pharmacokinetic profiles of multiple, oral doses of A-831 in male Hepatitis C carriers To determine the safety and tolerability of multiple, oral doses of A-831 in male Hepatitis C carriers;Secondary Objective: To determine the antiviral activity of multiple, oral doses of A-831 in male Hepatitis C carriers as measured by Q-RT-PCR for HCV RNA.;Primary end point(s): Please refer to primary and secondary objectives | — |
Countries
United Kingdom
Outcome results
None listed