Bioavailabity and food effects of the paediatric formulation of LDV/SOF in adult subjects

• Conditions: Chronic Hepatitis C virus infection; MedDRA version: 18.0Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 18.0Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-003570-32-Outside-EU/EEA
• Lead Sponsor: Gilead Sciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-14
• Last Update Posted: 17 August 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

1. Have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures
2. Be between 18 and 45 years of age, inclusive
3. Must have a calculated BMI between =19.0 to =30.0 kg/m2at Screening
4. Creatinine clearance (CLCr) must be = 90 mL/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at the Screening evaluation
5. Females of childbearing potential 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 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 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

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 (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies)
10. The following ECG abnormalities at Screening: QRS > 120 msec; heart rate < 45 beats per minute; second or third degree heart block, QTcF interval > 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 reason

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the relative bioavailability of a pediatric granules formulation of ledipasvir/sofosbuvir (LDV/SOF) relative to tablet<br>formulation in healthy subjects.<br><br>To evaluate the effect of concomitant food intake on the pharmacokinetics of a pediatric granules formulation of LDV/SOF.;Secondary Objective: 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.;Timepoint(s) of evaluation of this end point: Sceduled assessment points throughout the 28 day treatment period - PK will be taken at intervals Day 1, 11 and 21.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary endpoints are the incidences of AEs, laboratory abnormalities and vital signs.<br>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: Sceduled assessment points throughout the 28 day treatment period.