Human Immunodeficiency Virus (HIV-1) Infection
Conditions
Interventions
F
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
INN or Proposed INN: TENOFOVIR ALAFENAMIDE
CAS Number: 379270-37-8
Current Sponsor code: TAF
Concentration uni
F
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 60-
INN or Proposed INN: TENOFOVIR ALAFENAMIDE
CAS Number: 379270-37-8
Current Sponsor code: TAF
Concentration uni
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), which must be obtained prior to initiation of study procedures 2. Be aged 18 through 45 years of age, inclusive at screening 3. Be a nonsmoker. The use of nicotine or nicotine-containing products must be discontinued 90 days prior to the first dose of study drug 4. Have a calculated body mass index (BMI) of = 19.0 and = 30.0 kg/m2 at screening 5. Have a creatinine clearance (CLcr) = 90 mL/min (using the Cockcroft-Gault method {Cockcroft 1976}) based on serum creatinine and actual body weight as measured at screening 6. Females of childbearing potential must have a negative serum pregnancy test at screening and clinic admission (unless permanently sterile or greater than 2 years postmenopausal) 7. Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception. 8. Subjects must refrain from sperm and egg donation from clinic admission (eg, Day -1), throughout the study period, and continuing for at least 7 days following the last dose of study drug. 9. Subjects have not donated blood within 56 days of study entry or plasma within 7 days of study entry and must refrain from blood donation from clinic admission, throughout the study period, and Continuing for at least 30 days following the last dose of study drug. 10. Screening laboratory and 12-lead ECG evaluations must be without clinically significant abnormalities as assessed by the investigator 11. Have liver disease or liver function tests such as alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, and total bilirubin equal to or below the upper limit of normal at screening 12. Must be willing and able to comply with all study requirements 13. Must, in the opinion of the investigator, be in good health based upon medical history and physical examination, including vital signs. 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 198 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Be a lactating female 2. Have received any study drug within 30 days prior to study dosing 3. Have current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance or subject safety 4. Have a positive test result for human immunodeficiency virus type 1 (HIV-1) antibody, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody 5. Have poor venous access that limits phlebotomy 6. Have taken any prescription medications or over-the-counter medications, including herbal products, within 28 days prior to start of study drug dosing, with the exception of vitamins and/or acetaminophen and/or ibuprofen and/or hormonal contraceptive medications 7. Have been treated with systemic steroids, immunosuppressant therapies, or chemotherapeutic agents within 3 months prior to screening or is expected to receive these agents during the study (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies) 8. Have a history of any of the following: a) Significant serious skin disease, such as but not limited to rash, food allergy, eczema, psoriasis, or urticaria b) Significant drug sensitivity or drug allergy (such as anaphylaxis or hepatoxicity) c) Known hypersensitivity to the study drugs their metabolites or to formulation excipients d) Significant cardiac disease (including history of myocardial infarction based on ECG and/or clinical history, any history of ventricular tachycardia, congestive heart failure, or dilated cardiomyopathy with left ventricular ejection fraction 6 months) medical treatment. i) Medical or surgical treatment that permanently altered gastric absorption (eg, gastric or intestinal surgery). A history of cholecystectomy is not exclusionary. 9. Have any serious or active medical or psychiatric illness (including depression) that, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance with the protocol. This would include renal, cardiac, hematological, hepatic, pulmonary (including chronic asthma), endocrine (including diabetes), central nervous, gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease), immunodeficiency disorders, active infection, or malignancy that are clinically significant or requiring treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary endpoints are the PK parameters AUClast, AUCinf, and Cmax of BIC, FTC, and TAF in Cohorts 1 and 3, as applicable.;Timepoint(s) of evaluation of this end point: (Days 1, 10, and 19): predose (= 5 min), 5 min, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours postdose.;Main Objective: - To evaluate the relative bioavailability of a B/F/TAF FDC pediatric tablet for oral suspension formulation relative to the adult B/F/TAF FDC tablet formulation - To evaluate the bioequivalence of a F/TAF FDC pediatric tablet for oral suspension formulation relative to the B/F/TAF FDC pediatric tablet for oral suspension formulation;Secondary Objective: - To evaluate the effect of concomitant food intake on the PK of a B/F/TAF FDC pediatric tablet for oral suspension formulation - To evaluate the safety and tolerability of single doses of B/F/TAF and F/TAF FDC pediatric tablet for oral suspension formulations in healthy subjects | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints include PK parameters AUClast, AUCinf, and Cmax of BIC, FTC, and TAF under fasting and fed status in Cohort 2. Additional secondary endpoints include the incidences of AEs and laboratory abnormalities;Timepoint(s) of evaluation of this end point: (Days 1 and 12): predose (= 5 min), 5 min, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours postdose. | — |
Countries
United States
Contacts
Public ContactClinical Trials Mailbox
Gilead Sciences International Ltd.
Outcome results
None listed