Clinical trial NCT03123848: A Study to Evaluate the Pharmacokinetics (PK) of Darunavir (DRV) and Cobicistat (COBI) After a Single Oral Administration of Darunavir/Cobicistat Fixed-Dose Combination in Healthy Japanese Adult Participants
Official title: An Open-label Study to Evaluate the Pharmacokinetics (PK) of Darunavir (DRV) and Cobicistat (COBI) After a Single-oral Administration of Darunavir/Cobicistat Fixed-Dose Combination Tablet in Healthy Japanese Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2017-04-21
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of the study is to evaluate the pharmacokinetic (PK) and safety of darunavir (DRV) and cobicistat (COBI) after a single oral administration of Prezcobix (DRV/COBI fixed-dose combination tablet) in healthy Japanese adult participants.


Eligibility criteria: Inclusion Criteria:

* Participants must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. This determination must be recorded in the participants source documents and initialed by the investigator
* A woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin \[hCG\]) at screening and urine pregnancy test at the time of admission to the study site, hospitalization, and must not breast feed from screening onwards
* Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participant participating in clinical studies
* A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of at least 30 days after intake of the study drug
* Nonsmoker or participant who habitually smokes no more than 10 cigarettes or equivalent of e-cigarettes, or 2 cigars, or 2 pipes of tobacco per day for at least 6 months before study drug administration

Exclusion Criteria:

* Participant has a history of 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, liver or renal insufficiency (estimated creatinine clearance below 80 milliliter per minute \[mL/min\]); thyroid disease, neurologic or psychiatric disease, infection, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, metabolic disturbances or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
* Participant has a history of malignancy before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, that is considered cured with minimal risk of recurrence)
* Participant has a history of or current clinically significant skin reactions (such as but not limited to Stevens-Johnson Syndrome \[SJS\], Toxic Epidermal Necrolysis (TEN), and/or erythema multiforme) or any history of allergies to drugs, such as, but not limited to, sulfonamides and penicillins
* Participant has been contraindicated DRV and COBI per local prescribing information
* Participant is a woman, who is pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose
measure: Concentration at Last Quantifiable Time Point (Clast)
timeFrame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose
measure: Time to Reach the Maximum Plasma Concentration (Tmax)
timeFrame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Time the Last Quantifiable Time (AUC[0-last])
timeFrame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC0-infinity)
timeFrame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose
measure: Elimination Rate Constant (Lambda[z])
timeFrame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose
measure: Terminal Elimination Half-Life (t1/2)
timeFrame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose
measure: Apparent Volume of Distribution (Vz/F)
timeFrame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose
measure: Apparent Total Body Clearance of Drug at the Terminal Phase After Extravascular Administration (CL/F)
timeFrame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose
Secondary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to approximately 1 month
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Souseikai Hakata Clinic
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: STUDY_DIRECTOR
References: