chronic hepatitis c virus genotype 1 infection MedDRA version: 14.1 Level: LLT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Vertex Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects must be able to read, understand, sign the ICF, abide by the study requirements (e.g., comply with schedule visits, treatment regimen, laboratory tests, and other study procedures), and willing to complete the study as planned 2. Subjects must be healthy males and/or females of non-childbearing potential aged 18 to 65 years, inclusive. Healthy is defined as having no clinically relevant abnormalities identified by a detailed medical history and full physical examination (including blood pressure, pulse rate measurement, 12-lead ECGs, and clinical laboratory tests) at the Screening Visit. Non-childbearing potential is defined in Section 12.6.6. 3. Subjects with a body mass index (BMI) of 18 to 30 kg/m2 and weigh >50 kg at the Screening Visit. Only 3 subjects with a BMI greater than 29 kg/m2 will be enrolled in this 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 18 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects with a positive test result for any of the following infectious diseases: hepatitis A infection (confirmed by hepatitis A antibody IgM), hepatitis B antigen (HBsAG), hepatitis C virus antibody (HCV Ab), human immunodeficiency virus 1 and 2 antibodies (HIV 1 Ab or HIV 2 Ab) 2. Subjects with a history of any illness that, in the opinion of the investigator or the subject’s general practitioner, might confound the results of the study or pose an additional risk in administering study drug to the subject. This may include, but is not limited to, a history of (1) relevant drug or food allergies; (2) cardiovascular or central nervous system disease; (3) clinically significant pathology (history or presence); (4) mental disease; or (5) chronic skin disease. 3. Subjects with a history of febrile illness within 5 days prior to the first dose of study drug 4. Subjects with any condition that may possibly affect drug absorption (e.g., gastrectomy, cholecystectomy, or other gastrointestinal track surgery, except appendectomy) 5. Subjects with a positive urine screen result for drugs of abuse (Table 12-2) 6. Subjects with a history of regular alcohol consumption exceeding 7 drinks/week for female subjects of non-childbearing potential or 14 drinks/week for male subjects, where 1 drink = 5 ounces (150 mL) of wine, 12 ounces (360 mL) of beer, or 1.5 ounces (45 mL) of hard liquor within 6 months of the Screening Visit 7. Subjects treated with an investigational drug within 30 days (or as determined by the local requirements, whichever is longer) or 5 half-lives preceding the first dose of study drug 8. Subjects with 12-lead ECG demonstrating QTc >450 msec at the Screening Visit. If the QTc exceeds 450 msec, then the ECG should be repeated 2 more times and the average of the 3 QTc values should be used to determine the subject’s eligibility 9. Subjects who use prescription and/or nonprescription drugs within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study drug. 10. Subjects who use vitamins and/or dietary supplements within 7 days before the first dose of study drug. Herbal supplements must be discontinued 14 days prior to the first dose of study drug. 11. Hormone replacement therapy must be discontinued 28 days prior to the first dose of study drug. Depo-Provera must be discontinued at least 6 months prior to the first dose of study drug. As an exception, acetaminophen/paracetamol may be used at doses of =1g/day. Limited use of non-prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by Vertex Pharmaceuticals Incorporated (Vertex). 12. Subjects who have made a blood donation of approximately 1 pint (500 mL) within 56 days prior to the first dose of study drug 13. Subjects who are unwilling or unable to comply with the Lifestyle Guidelines, as described in Section 10.3 14. Subjects who are an investigator, sub-investigator, research assistant, pharmacist, study coordinator, staff, or a relative of study personnel directly involved with the conduct of the study 15. Subjects who consume an average of more than five 8-ounce servings of coffee or other caffeinated beverage or seven 8-ounce servings of cola per day up to 72 hours before the first dose of study drug 16. Subjects who have a female partner who is pregnant, nursing, or planning to bec
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To determine the bioavailability of telaprevir administered as a pediatric chewable tablet formulation relative to a 375-mg core tablet formulation in the fed state - To evaluate the effect of food on the pharmacokinetics of telaprevir administered as a pediatric chewable tablet formulation;Secondary Objective: To assess the safety and tolerability of a single dose of telaprevir when administered to healthy adult subjects in the fed and fasted states;Primary end point(s): Pharmacokinetic exposure measurements, including maximum observed concentration (Cmax), area under the plasma concentration-time curve (AUC) from time 0h extrapolated to infinity (AUC8), and AUC from time 0h to the last time point with a concentration above the lower limit of quantification or the last sampling time in a steady-state dosing interval (AUCtlast) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Time to reach Cmax after dosing (time of maximum concentration, tmax) and terminal half-life (t1/2) - Safety and tolerability as assessed by adverse events and changes in laboratory test values (chemistry and hematology), vital signs, 12-lead electrocardiograms (ECGs), and physical examinations | — |
Countries
United States
Contacts
Public ContactCentral Contact Center
Vertex Pharmaceuticals Incorporated
Outcome results
None listed