Chronic Hepatitis C virus infection MedDRA version: 20.0 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.0 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Harvoni 90 mg/400 mg film-coated tablets
Product Name: Harvoni
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Ledipasvir
CAS Number: 1256388-51-8
Other descriptive name: LEDI
Sponsors
Gilead Sciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for participation in this study. 1. Have the ability to understand and sign a written informed consent form (ICF), 2. Be between 18 and 45 years of age, inclusive 3. Must have a calculated BMI between =19.0 to =30.0 kg/m2 at Screening 4. Creatinine clearance (CLCr) must be =90 mL/min 5. Females of childbearing potential (as defined in Appendix 3) must have a negative serum pregnancy test at Screening and Day -1 6. Females of childbearing potential must agree to utilize protocol recommended highly effective contraception methods (as defined in Appendix 3) from 3 weeks prior to clinic admission until 30 days following the last dose of study drug 7. Male subjects must agree to utilize a highly effective method of contraception (as defined in Appendix 3) during heterosexual intercourse from clinic admission until 90 days following the last dose of study drug. 8. Male subjects must agree to refrain from sperm donation from Day -1 until at least 90 days after the study drug dose 9. Subjects must have refrained from blood donation within 56 days or plasma donation within 7 days of study dosing and from clinic admission until 30 days following the last dose of study drug 10. In the opinion of the investigator, subjects must be in good health based upon medical history and physical examination (including vital signs) 11. Screening laboratory evaluations without clinically significant abnormalities as assessed by the investigator 12. Be willing and able to comply with all study requirements 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 42 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following exclusion criteria are not to be enrolled in this study. 1. Alcohol or substance abuse as assessed by the investigator 2. A positive screening test result for human immunodeficiency virus type 1 (HIV-1) antibody, Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV) antibody 3. Nursing female 4. Have previously been participated in an investigational trial involving administration of any investigational compound (last dose) within 30 days prior to the study dosing (Day 1) 5. Have poor venous access limiting phlebotomy 6. Have been vaccinated within 90 days, or for the influenza vaccine, within 14 days prior to study dosing 7. Have taken any prescription medications or over-the-counter medications including herbal products within 28 days of commencing study drug dosing with the exception of vitamins and/or acetaminophen and/or ibuprofen and/or hormonal contraceptive medications 8. Have taken systemic steroids, immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening or expected to receive these agents during the study 9. Have a history of any of the following: a. Significant drug sensitivity or drug allergy (such as anaphylaxis or hepatoxicity) b. Significant serious skin disease, such as but not limited to, rash or eruptions, food allergy, eczema, psoriasis, or urticaria c. Known hypersensitivity to the study drugs, the metabolites or to formulation excipients (see Section 5.2.1) d. Syncope, palpitations, or unexplained dizziness e. Liver disease or liver function tests such as alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT), aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT), serum total bilirubin, or alkaline phosphatase above the upper limit of normal at Screening f. Severe peptic ulcer disease, gastroesophageal reflux disease, or other gastric acid hypersecretory conditions requiring prolonged (> 6 months) medical treatment g. Medical or surgical treatment that permanently alters gastric absorption (eg, gastric or intestinal surgery) h. Significant cardiac disease (including history of myocardial infarction based on electrocardiogram [ECG] and/or clinical history, any history of ventricular tachycardia, congestive heart failure, or dilated cardiomyopathy with left ventricular ejection fraction 120 msec; heart rate 450 msec for males or > 470 msec for females; PR interval > 200 msec and any other clinically relevant abnormality 11. Believed, by the study investigator, to be inappropriate for study participation for any reasond. Syncope, palpitations, or unexplained dizziness e. Liver disease or liver function tests such as alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT), aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT), serum total bilirubin, or alkaline phosphatase above the upper limit of normal at Screening f. Severe peptic ulcer disease, gastroesophageal reflux disease, or other gastric acid hypersecretory conditions requiring prolonged (> 6 months) medical treatment g. Medical or surgical treatment that permanently alters gastric absorption (eg, gastric or intestinal surgery) h. Significant cardiac disease (including history of myocardial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Scheduled assessment points throughout the treatment period;Main Objective: The primary objectives of this study are as follows: ? To evaluate the relative bioavailability of a pediatric granules formulation of LDV/SOF relative to tablet formulation in healthy subjects. ? To evaluate the effect of concomitant food intake on the pharmacokinetics of a pediatric granules formulation LDV/SOF. ;Secondary Objective: The secondary objective of this study is as follows: ? To evaluate the safety and tolerability of a pediatric granules formulation of LDV/SOF following single-dose administration in healthy subjects.;Primary end point(s): The primary endpoints are PK parameters Cmax, AUClast, and AUCinf, for SOF, GS-566500, GS-331007, and LDV. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are the incidences of AEs, laboratory abnormalities and vital signs. The secondary PK endpoints are % AUCexp, Tmax, Clast, Tlast, ?z, CL/F, and t1/2 as appropriate.;Timepoint(s) of evaluation of this end point: Scheduled assessment points throughout the treatment period | — |
Countries
United States
Contacts
Public ContactBenedetta Massetto
Gilead Sciences, Inc.
Outcome results
None listed