Healthy Volunteers
Conditions
Sponsors
Janssen Sciences Ireland UC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The subject: 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 (other than those listed in inclusion criterion 10 [for blood pressure]), 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. 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. 7. Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for subject participating in clinical studies. Before randomization, a female subject must be either: a. Not of childbearing potential defined as: - premenarchal A premenarchal state is one in which menarche has not yet occurred - postmenopausal A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level (>33.4 IU/L or mIU/mL in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy, however in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. If there is a question about menopausal status in women on hormone replacement therapy (HRT), the woman will be required to use one of the non-estrogen-containing hormonal highly effective contraceptive methods if she wishes to continue HRT during the study. - permanently sterile Permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy. b. Of childbearing potential and - be not heterosexually active, or have a vasectomized partner for the duration of the study and for at least 90 days after receiving the last dose of study drug OR - practicing a highly effective method of birth control (as specified below) before entry and agree to continue to use a highly effective method of contraception throughout the study, and for at least 90 days after receiving the last dose of study drug. Women with tubal ligation are required to use one additional contraceptive method. Note: Estrogenbased horm
Exclusion criteria
Exclusion criteria: 1. 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 <90 mL/min at screening), gastrointestinal disease (such as significant diarrhea, gastric stasis, or constipation that in the investigator’s opinion could influence drug absorption or bioavailability), thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results. 2. One or more of laboratory abnormalities at screening as defined by the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events and in accordance with the normal ranges of the clinical laboratory. 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. History of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticaria. 5. Has taken any disallowed therapies as noted in Section 5.5 of the protocol before the planned first intake of study drug. 6. History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria within 1 year before screening or positive test result(s) for alcohol and/or drugs of abuse either at screening or on Day -1 of each treatment period. 7. A history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy diagnosed in previous studies with experimental drugs. 8. Known allergies, hypersensitivity, or intolerance to DRV, COBI, FTC, and/or TAF, or any of their excipients. 9. Known allergy to heparin or history of heparin induced thrombocytopenia. 10. Donation of blood or plasma within 2 months preceding the first intake of study drug or intention to donate blood or blood products during the study. 11. Has received an investigational drug or used an investigational medical device within 60 days before the first intake of study drug. 12. Woman who is pregnant, or breast-feeding, or planning to become pregnant during this study or within 90 days after the last intake of study drug, or a woman of childbearing potential who is unwilling to use acceptable methods of contraception. 13. Man who plans to father a child while enrolled in this study or within 90 days after the last intake of study drug, or who is unwilling to use acceptable methods of contraception. 14. A story of hepatitis A antibody immunoglobulin M (IgM), hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for hepatitis A antibody IgM, HBsAg or anti-HCV at screening. 15. A history of HIV-1 or HIV-2 infection, or tests positive for HIV-1 or HIV-2 at screening. 16. A history of smoking or use of nicotine-containing substances within 2 months prior to screening, as determined by medical history or subject’s verbal report. A urine cotinine test will be perfor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the single-dose PK and pivotal bioequivalence of 3 compounds DRV 675 mg, FTC 200 mg, and TAF 10 mg in the presence of COBI 150 mg when administered as an FDC (D/C/F/TAF) compared to the co-administration as the separate commercial formulations (DRV 1×600 mg and 1×75 mg tablet and F/TAF 1×200 mg/10 mg tablet and COBI 1×150 mg tablet), under fed conditions, in healthy subjects.;Timepoint(s) of evaluation of this end point: Throughout study;Secondary Objective: - To evaluate the single-dose PK and relative bioavailability of COBI 150 mg in the presence of DRV 675 mg, FTC 200 mg, and TAF 10 mg when administered as an FDC (D/C/F/TAF) compared to co-administration as the separate commercial formulations (COBI 1×150 mg tablet in the presence of DRV 1×600 mg and 1×75 mg tablet and F/TAF 1×200 mg/10 mg tablet), under fed conditions, in healthy subjects. - To evaluate the short-term safety and tolerability of co-administration of DRV 675 mg, COBI 150 mg, FTC 200 mg, and TAF 10 mg, under fed conditions, in healthy subjects. ;Primary end point(s): The assessment of specified PK parameters for DRV, COBI, FTC, and TAF for each treatment period: Cmax, tmax, AUClast, AUC8, Clast, tlast, ?z, and t1/2. Other PK parameters may be estimated as appropriate for exploration of the data. For the PK parameters, definitions and methods of calculation are: - 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; - AUC8 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-belo | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The study will include the following evaluations of safety and tolerability: - Adverse events will be reported by the subject (or, when appropriate, by a caregiver, surrogate, or the subject's legally acceptable representative) for the duration of the study - Blood samples for serum biochemistry, blood coagulation (Screening only), and hematology and a random urine sample for urinalysis will be collected. The investigator must review the laboratory report, document this review, and record any clinically relevant changes occurring during the study in the adverse event section of the CRF. - Electrocardiogram (ECG) - Vital signs - Physical Examination including height, body weight, and skin examination. -Alcohol Urine Test - Specific Toxicities including but not limited to rash, Acute Allergic Reaction and Clinical Hepatitis. ;Timepoint(s) of evaluation of this end point: Throughout study | — |
Countries
Netherlands
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed