Human Immunodeficiency Virus (HIV-1) Infections MedDRA version: 17.1 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 100000004862
Conditions
Interventions
Product Name: COBI
Product Code: GS-9350
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: COBICISTAT
CAS Number: 1004316-88-4
Current Sponsor code: GS-9350
Other descriptive name: COBI
Con
Sponsors
Gilead Sciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures 2) Must be between 18 and 45 years of age, inclusive 3) Must 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) Must have a calculated body mass index (BMI) from 19 = BMI = 30 at study screening 5) Must be HIV-1 antibody negative 6) Must be hepatitis B (HBV) surface antigen negative 7) Must be hepatitis C (HCV) antibody negative 8) Have an estimated creatinine clearance (CLCr) = 90 mL/min (using the Cockcroft-Gault method) 9) Females of childbearing potential must have a negative serum pregnancy test 10) Females of childbearing potential must agree to utilize protocol recommended highly effective contraception methods from 3 weeks prior to baseline throughout the duration of study treatment and for 30 days following the last dose of study drug 11) Female subjects who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least 3 months prior to study dosing 12) Male subjects must agree to utilize a highly effective method of contraception during heterosexual intercourse throughout the study period and for 30 days following discontinuation of investigational medicinal product 13) Male subjects must refrain from sperm donation from Day -1 through completion of the study and continuing for at least 30 days from the date of last dose of study drug 14) Subjects must refrain from blood donation from Day -1 through completion of the study and continuing for at least 30 days from date of last dose of study drug 15) Must, in the opinion of the Investigator, be in good health based upon medical history, physical examination, and screening laboratory evaluations (hematology, chemistry, and urinalysis) must fall within the normal range of the local laboratory’s reference ranges unless the results have been determined by the Investigator to have no clinical significance. Subjects must have ALT, AST and total bilirubin within or below the normal range 16) Have either a normal 12-lead electrocardiogram (ECG) or one with abnormalities that are considered clinically insignificant by the Investigator in consultation with the Sponsor. Subjects must have PR between 120 – 210 msec, and QTcF of =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Pregnant or lactating subjects 2) Have any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with subject treatment, assessment, or compliance with the protocol 3) Have previously participated in an investigational trial involving administration of any investigational compound within 30 days prior to the study dosing 4) Current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance 5) Have poor venous access and are unable to donate blood 6) Have donated blood within 56 days of study dosing 7) Have donated plasma within 7 days of study dosing 8) 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 9) Have history of significant drug sensitivity or drug allergy 10) Known hypersensitivity to the study drugs, the metabolites or formulation excipients 11) Have been treated with systemic steroids, immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening or expected to receive these agents during the study 12) Have a history or family history of Long QT Syndrome, Wolfe-Parkinson-White Syndrome, or have a family history of sudden cardiac death or unexplained death in an otherwise healthy individual between the ages of 1 and 40 years 13) History of syncope, palpitations, or unexplained dizziness 14) Have an implanted defibrillator or pacemaker 15) Have a history of liver disease, including Gilbert’s Disease 16) Are unable to comply with study requirements 17) Believed, by the study Investigator, to be inappropriate for study participation for any reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the relative bioavailability of two age-appropriate pediatric formulations (immediate release tablet or dispersible tablet as suspension) of COBI in healthy adult subjects;Secondary Objective: To evaluate the safety of two age-appropriate pediatric formulations (immediate release tablet or dispersible tablet as suspension) of COBI in healthy adult subjects To evaluate the acceptability of COBI formulations in healthy adult subjects;Primary end point(s): The primary endpoints are the pharmacokinetic (PK) parameters AUClast, AUCinf, and Cmax for COBI.;Timepoint(s) of evaluation of this end point: PK assessments: Days 1 and 8: serial blood samples will be collected at the following time points relative to dosing: 0 (predose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 20, 24, 28, 36, and 48 hours post-dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are %AUC_exp, Tmax, Clast, Tlast, ?z, T1/2, clearance and volume of distribution for COBI, acceptability for COBI formulations, and incidences of adverse events and laboratory abnormalities;Timepoint(s) of evaluation of this end point: PK assessments: Days 1 and 8: serial blood samples will be collected at the following time points relative to dosing: 0 (predose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 16, 20, 24, 28, 36, and 48 hours post-dose. Safety assessments, acceptability and AEs to be collected from baseline to day 15 follow-up visits. | — |
Countries
United States
Contacts
Public ContactClinical Trial Information Desk
Gilead Sciences, Inc.
Outcome results
None listed