Human Immunodeficiency Virus-1 (Healthy participants) MedDRA version: 20.1 Level: LLT Classification code 10020443 Term: Human immunodeficiency virus syndrome System Organ Class: 100000004862
Conditions
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Each potential participant must satisfy all of the following criteria to be enrolled in the study: 1. 18 to 55 years of age, inclusive. 2. Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. 3. Healthy on the basis of clinical laboratory tests performed at screening. 4. Body weight not less than 50 kg and body mass index (BMI; weight [kg]/height2 [m]2) within the range 18.5 - 30.0 kg/m2 (inclusive). 5. Man or woman (according to their reproductive organs and functions assigned by chromosomal complement). 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 32 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any potential participant who meets any of the following criteria will be excluded from participating in the study: 1. History of or current clinically significant medical illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results. 2. History of malignancy within 5 years before screening. 3. Has one or more laboratory abnormalities at screening or at Day -1. 4. Clinically significant abnormalities during physical examination, vital signs, or 12-lead ECG at screening or at admission to the study site as deemed appropriate by the investigator. 5. Current or chronic history of liver disease. 6. Known hepatic or biliary abnormalities. 7. Known allergies, hypersensitivity, or intolerance to darunavir and/or cobicistat or its excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the single-dose PK and bioequivalence of DRV 600 mg in the presence of COBI 90 mg when administered as a DRV/COBI FDC tablet dispersed in water compared to the co-administration of the separate available formulations, under fed conditions in healthy participants.;Secondary Objective: The secondary objectives are: • To evaluate the single-dose PK and relative bioavailability of COBI 90 mg in the presence of DRV 600 mg when administered as a DRV/COBI FDC tablet compared to co-administration of the separate available formulations, under fed conditions in healthy participants. • To evaluate the short-term safety and tolerability of co-administration of DRV 600 mg and COBI 90 mg, under fed conditions in healthy participants.;Primary end point(s): 1. PK and bioequivalence a. Cmax: The maximum observed plasma analyte concentration b. 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. c. AUC8: AUC from time 0 to infinite time, 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. d. Clast: The last observed measurable (non-BQL) plasma analyte concentration. e. ?z: Apparent terminal elimination rate constant, determined by linear regression using the terminal log-linear phase of the log-transformed concentration vs time curve.;Timepoint(s) of evaluation of this end point: Throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. PK and relative bioavailability a. Cmax: The maximum observed plasma analyte concentration b. 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. c. AUC8: AUC from time 0 to infinite time, 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. d. Clast: The last observed measurable (non-BQL) plasma analyte concentration. e. ?z: Apparent terminal elimination rate constant, determined by linear regression using the terminal log-linear phase of the log-transformed concentration vs time curve. 2. Safety and tolerability a. Serious adverse events b. Physical examination c. Clinical laboratory results d. Vital signs;Timepoint(s) of evaluation of this end point: Throughout the study | — |
Countries
Belgium
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed