HCV Hepatitis C Virus infection infection of the liver
Conditions
Interventions
Screening:
The following assessments will be performed to evaluate eligibility:
• Signed, written informed consent
• Inclusion/exclusion criteria
• Previous medical/surgical history
• Complete physica
Sponsors
Roche Nederland B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male subjects, 18 to 45 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, and urinalysis. 2. Body mass index (BMI) between 18 and 30 kg/mE2, inclusive (Part A) and between 18 and 26 kg/mE2, inclusive (Part B), and with a minimum weight of 50 kg. 3. Subjects and their partners of childbearing potential must use 2 methods of contraception, one of which must be a barrier method for the duration of the study and for 70 days after the last dose. 4. Able to participate and willing to give written informed consent and to comply with the study restrictions.
Exclusion criteria
Exclusion criteria: 1. Positive test for drugs of abuse at screening or Day -2. 2. History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol). Alcohol consumption will be prohibited during study confinement and at least 48 hours before screening, before dosing, and before each scheduled visit. 3. History or symptoms of any significant disease including (but not limited to), neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder. 4. History of active malignancy within the last 5 years, with the exception of localized or in situ carcinoma (e.g., skin basal or squamous cell carcinoma). 5. Positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab) or human immunodeficiency virus antibody (HIV Ab) at screening. 6. Confirmed (based on the average of 3 semi-supine, resting blood pressure measurements, properly measured with well-maintained equipment, at each of > 2 visits to the office or clinic) systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg. 7. Use of any medications (prescription or over-the-counter [OTC]), vitamin, mineral, herbal, and dietary supplements within 21 days of study drug administration, or less than 5 half-lives (whichever is longer). Exceptions are paracetamol (up to 4 g/day) and ibuprofen (up to 1g/day). Other exceptions will only be made if the rationale is discussed and clearly documented between the Investigator and the Roche*s Clinical Pharmacologist. 8. Clinically significant abnormalities in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis). In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant for healthy subjects. 9. Participation in an investigational drug or device study within 3 months prior to screening. 10. Donation of blood over 500 mL within three months prior to screening. 11. Concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this study. 12. Smoker of more than 10 cigarettes per day prior to Screening or who use tobacco products equivalent to more than 10 cigarettes per day. 13. Any of the following findings in the resting ECG. a) QTcF> 450 or 100 bpm) at screening or baseline visit; c) Personal or family history of congenital long QT syndrome or sudden death; d) Screening or baseline ECG with QRS and/or T wave judged to be unfavorable for a consistently accurate QT measurement (e.g., neuromuscular artifact that cannot be readily eliminated, arrhythmias, indistinct QRS onset, low amplitude T wave, merged T- and U-waves, prominent U waves); e) Evidence of atrial fibrillation, atrial flutter, complete branch block, Wolf-Parkinson-White Syndrome, or cardiac pacemaker at screening or baseline visit. 14. Any confirmed significant allergic reactions (u
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study variables of single doses of RO1080713, Part A and B, are -the safety and tolerability variables: -the primary pharmacokinetic study parameters: AUC and Cmax of RO1080713 | — |
Secondary
| Measure | Time frame |
|---|---|
| -other pharmacokinetic parameters -all pharmacodynamic parameters of RO1080713 and/or other metabolites as needed for all treated subjects | — |
Countries
Netherlands
Outcome results
None listed