AIDS HIV
Conditions
Sponsors
Janssen Sciences Ireland UC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Subjects must satisfy the following criteria to be enrolled in the study: 1. Must be a man or woman between 18 and 55 years of age, extremes included, at screening. 2. Must have a body mass index (BMI; weight [kg]/height2 [m]2) between 18.5 and 30.0 kg/m2 (extremes included), and a body weight of not less than 50 kg at screening. 3. Must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study, before any study-related procedures take place. 4. Must be healthy on the basis of physical examination, medical history, vital signs, and ECG performed at screening (results must be available on Day -1). If there are abnormalities the subject may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the subject's source documents and initialed by the investigator. 5. Subject must be healthy on the basis of clinical laboratory test performed at screening (results must be available on Day -1). If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges (other than those listed in exclusion criterion 2), the subject may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the subject's source documents and initialed by the investigator. 6. A woman (of childbearing potential) must have a negative highly sensitive serum betahuman chorionic gonadotropin pregnancy test, 4 days or less before dosing of the first treatment period.
Exclusion criteria
Exclusion criteria: Any potential subject who meets any of the following criteria will be excluded from participating in the study: 1. Has history or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease (including bronchospastic respiratory disease), diabetes mellitus, hepatic or renal insufficiency (eg, estimated creatinine clearance below =1.1 x upper limit of laboratory normal range [ULN]) or creatinine clearance (using the CKD-EPI formula) =1.1 x ULN), and/or total amylase Grade 2 or greater (>=1.5 x ULN). - Hemoglobin (Hb) Grade 1 or greater (Female: =1.25 x ULN). - Total bilirubin Grade 2 or greater (>=1.6 x ULN). - For proteinuria (spot urine) >=2+. - Microscopic hematuria (>=5 red blood cells [RBC]/hpf); if a female subject is menstruating at the time of screening a urine retest is to be performed after the menstrual period. - Any other laboratory abnormality of grade 2 or greater. For low-density lipoprotein (LDL) cholesterol values corresponding to DAIDS grade 2 or greater, subjects will not to be excluded as long as the value is not higher than ULN of the local lab. 3. Clinically significant abnormalities during physical examination, vital signs, or 12-lead electrocardiogram (ECG) at screening or at admission to the study center as deemed appropriate by the investigator. 4. With any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticaria. 5. No medication, including over-the-counter products, systemic herbal medications or dietary supplements including products containing Hypericum perforatum (St. John*s wort) can be used at least 14 days (or longer, based on 5 times the elimination half-life) before the first intake of study drug (on Day 1 of the first treatment period) until collection of the last PK sample, except for paracetamol (acetaminophen) or ibuprofen, hormone replacement therapy in postmenopausal women, and hormone-based contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following PK parameters for Darunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamide will be determined for each treatment period: - Cmax maximum observed analyte concentration; - tmax the actual sampling time to reach the maximum observed analyte concentration; - AUClast area under the analyte concentration-time curve (AUC) from time 0 to the time of the last measurable (non-below quantification limit [non-BQL]) concentration, calculated by linear-linear trapezoidal summation; - AUC* AUC from time 0 to infinity, calculated as AUClast + Clast/*z, where Clast is the last observed measurable (non-BQL) concentration; extrapolations of more than 20.00% of the total AUC are reported as approximations; - Clast last observed measurable (non-below quantification limit [BQL]) analyte concentration; - tlast the actual sampling time of the last measurable (non-BQL) analyte concentration - *z apparent terminal elimination rate constant, determined by linear regression using the terminal log-linear phase of the log-transformed concentration vs. time curve; - t1/2 apparent terminal elimination half-life, defined as 0.693/*z. | — |
Secondary
| Measure | Time frame |
|---|---|
| The study will include the following evaluations of safety and tolerability: • Adverse events • Clinical laboratory • Vital signs • ECG • Physical examination | — |
Countries
Netherlands
Outcome results
None listed