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| ID | Type | Description | Link |
|---|---|---|---|
| TMC114FD1HTX4002 | Other Identifier | Janssen Pharmaceutical K.K., Japan |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Darunavir/Cobicistat FDC (Prezcobix) | Experimental | Participants will receive one darunavir/cobicistat fixed-dose combination (FDC) tablet, containing 800 milligram (mg) of darunavir (DRV) and 150 mg of cobicistat (COBI) in the morning on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Darunavir/Cobicistat | Drug | Participants will receive a FDC tablet of darunavir 800 mg and cobicistat 150 mg orally in the morning of Day 1. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | The Cmax is the maximum observed plasma concentration. | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose |
| Concentration at Last Quantifiable Time Point (Clast) | Clast is defined as concentration at last quantifiable time point. | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose |
| Time to Reach the Maximum Plasma Concentration (Tmax) | Tmax is defined as the time to reach the maximum plasma concentration. | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Time the Last Quantifiable Time (AUC[0-last]) | AUC(0-last) is defined as area under the plasma concentration-time curve from time zero to time the last quantifiable time, calculated by linear trapezoidal summation. | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC0-infinity) | AUC(0-infinity) is defined as area under the plasma concentration-time curve from time zero to infinite time. | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose |
| Elimination Rate Constant (Lambda[z]) | Lambda(z) is first-order rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. | Up to approximately 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K., Japan Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Souseikai Hakata Clinic | Fukuoka | 8120025 | Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | Darunavir 800 mg/Cobicistat 150 mg as FDC (Prezcobix) | Participants received darunavir 800 milligram (mg) and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) once orally on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 3, 2017 | May 15, 2018 |
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| Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose |
| Terminal Elimination Half-Life (t1/2) | t1/2 is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z). | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose |
| Apparent Volume of Distribution (Vz/F) | Vz/F is defined as the apparent volume of distribution at the terminal phase after extravascular administration. | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose |
| Apparent Total Body Clearance of Drug at the Terminal Phase After Extravascular Administration (CL/F) | CL/F is the apparent total body clearance of drug at the terminal phase after extravascular administration. | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Darunavir 800 mg/Cobicistat 150 mg as FDC (Prezcobix) | Participants received darunavir 800 milligram (mg) and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) once orally on Day 1. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
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| Primary | Maximum Observed Plasma Concentration (Cmax) | The Cmax is the maximum observed plasma concentration. | Pharmacokinetic (PK) analysis set included all participants who received the study drug and had at least one plasma concentration data-point after administration. Cmax for each analyte (Darunavir and Cobicistat) of fixed dose combination has been reported separately in each arm as per planned analysis. | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose |
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| Primary | Concentration at Last Quantifiable Time Point (Clast) | Clast is defined as concentration at last quantifiable time point. | PK analysis set included all participants who received the study drug and had at least one plasma concentration data-point after administration. Clast for each analyte (Darunavir and Cobicistat) of fixed dose combination has been reported separately in each arm as per planned analysis. | Posted | Mean | Standard Deviation | ng/mL | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose |
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| Primary | Time to Reach the Maximum Plasma Concentration (Tmax) | Tmax is defined as the time to reach the maximum plasma concentration. | PK analysis set included all participants who received the study drug and had at least one plasma concentration data-point after administration. Tmax for each analyte (Darunavir and Cobicistat) of fixed dose combination has been reported separately in each arm as per planned analysis. | Posted | Median | Full Range | hour (h) | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose |
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| Primary | Area Under the Plasma Concentration-Time Curve From Time Zero to Time the Last Quantifiable Time (AUC[0-last]) | AUC(0-last) is defined as area under the plasma concentration-time curve from time zero to time the last quantifiable time, calculated by linear trapezoidal summation. | PK analysis set included all participants who received the study drug and had at least one plasma concentration data-point after administration time zero to time the last quantifiable time. AUC[0-last] for each analyte (Darunavir and Cobicistat) of fixed dose combination has been reported separately in each arm as per planned analysis. | Posted | Mean | Standard Deviation | hour*nanogram per milliliter (h*ng/mL) | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose |
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| Primary | Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC0-infinity) | AUC(0-infinity) is defined as area under the plasma concentration-time curve from time zero to infinite time. | PK analysis set included all participants who received the study drug and had at least one plasma concentration data-point after administration. AUC0-inf for each analyte (Darunavir and Cobicistat) of fixed dose combination has been reported separately in each arm as per planned analysis. | Posted | Mean | Standard Deviation | h*ng/mL | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose |
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| Primary | Elimination Rate Constant (Lambda[z]) | Lambda(z) is first-order rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve. | PK analysis set included all participants who received the study drug and had at least one plasma concentration data-point after administration. Lambda[z] for each analyte (Darunavir and Cobicistat) of fixed dose combination has been reported separately in each arm as per planned analysis. | Posted | Mean | Standard Deviation | per hour (1/h) | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose |
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| Primary | Terminal Elimination Half-Life (t1/2) | t1/2 is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z). | PK analysis set included all participants who received the study drug and had at least one plasma concentration data-point after administration. t1/2 for each analyte (Darunavir and Cobicistat) of fixed dose combination has been reported separately in each arm as per planned analysis. | Posted | Mean | Standard Deviation | Hour | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose |
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| Primary | Apparent Volume of Distribution (Vz/F) | Vz/F is defined as the apparent volume of distribution at the terminal phase after extravascular administration. | PK analysis set included all participants who received the study drug and had at least one plasma concentration data-point after administration. Vz/F for each analyte (Darunavir and Cobicistat) of fixed dose combination has been reported separately in each arm as per planned analysis. | Posted | Mean | Standard Deviation | milliliter (mL) | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose |
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| Primary | Apparent Total Body Clearance of Drug at the Terminal Phase After Extravascular Administration (CL/F) | CL/F is the apparent total body clearance of drug at the terminal phase after extravascular administration. | PK analysis set included all participants who received the study drug and had at least one plasma concentration data-point after administration. CL/F for each analyte (Darunavir and Cobicistat) of fixed dose combination has been reported separately in each arm as per planned analysis. | Posted | Mean | Standard Deviation | milliliter per hour (mL/h) | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose |
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| Secondary | Number of Participants With Adverse Events (AEs) | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. | Safety analysis set included all participants who received the study drug. AEs for each analyte (Darunavir and Cobicistat) of fixed dose combination has been reported separately as per planned analysis. | Posted | Number | Participants | Up to approximately 1 month |
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Up to approximately 1 month
Safety analysis set included all participants who received the study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Darunavir 800 mg/Cobicistat 150 mg as FDC (Prezcobix) | Participants received darunavir 800 milligram (mg) and Cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) once orally on Day 1. | 0 | 8 | 0 | 8 | 0 | 8 |
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If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, IDV Department | Janssen Pharmaceutical K.K. | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 7, 2017 | May 15, 2018 | SAP_001.pdf |
| ID | Term |
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| C000711687 | cobicistat mixture with darunavir |
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