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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

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ClinicalTrials.gov Identifier: NCT03123848
Recruitment Status : Completed
First Posted : April 21, 2017
Results First Posted : June 12, 2018
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Healthy
Intervention Drug: Darunavir/Cobicistat
Enrollment 8
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Darunavir 800 mg/Cobicistat 150 mg as FDC (Prezcobix)
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 8
Completed 8
Not Completed 0
Arm/Group Title Darunavir 800 mg/Cobicistat 150 mg as FDC (Prezcobix)
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants
33.1  (6.10)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Male Number Analyzed 8 participants
8
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
8
 100.0%
Unknown or Not Reported
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Asian Number Analyzed 8 participants
8
 100.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
JAPAN Number Analyzed 8 participants
8
 100.0%
1.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax)
Hide Description The Cmax is the maximum observed plasma concentration.
Time Frame Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Darunavir 800 mg (FDC: Darunavir 800/Cobicistat 150 mg) Cobicistat 150 mg (FDC: Darunavir 800/Cobicistat 150 mg)
Hide Arm/Group Description:
Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) once orally on Day 1.
Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) once orally on Day 1.
Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/mL)
5496  (952) 832  (265)
2.Primary Outcome
Title Concentration at Last Quantifiable Time Point (Clast)
Hide Description Clast is defined as concentration at last quantifiable time point.
Time Frame Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Darunavir 800 mg (FDC: Darunavir 800/Cobicistat 150 mg) Cobicistat 150 mg (FDC: Darunavir 800/Cobicistat 150 mg)
Hide Arm/Group Description:
Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) once orally on Day 1.
Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) once orally on Day 1.
Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: ng/mL
33.3  (60.3) 8.59  (3.24)
3.Primary Outcome
Title Time to Reach the Maximum Plasma Concentration (Tmax)
Hide Description Tmax is defined as the time to reach the maximum plasma concentration.
Time Frame Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Darunavir 800 mg (FDC: Darunavir 800/Cobicistat 150 mg) Cobicistat 150 mg (FDC: Darunavir 800/Cobicistat 150 mg)
Hide Arm/Group Description:
Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) once orally on Day 1.
Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) once orally on Day 1.
Overall Number of Participants Analyzed 8 8
Median (Full Range)
Unit of Measure: hour (h)
4.00
(3.00 to 4.00)
4.00
(2.00 to 4.00)
4.Primary Outcome
Title Area Under the Plasma Concentration-Time Curve From Time Zero to Time the Last Quantifiable Time (AUC[0-last])
Hide Description 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.
Time Frame Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Darunavir 800 mg (FDC: Darunavir 800/Cobicistat 150 mg) Cobicistat 150 mg (FDC: Darunavir 800/Cobicistat 150 mg)
Hide Arm/Group Description:
Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) once orally on Day 1.
Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) once orally on Day 1.
Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: hour*nanogram per milliliter (h*ng/mL)
51274  (15983) 5667  (3119)
5.Primary Outcome
Title Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC0-infinity)
Hide Description AUC(0-infinity) is defined as area under the plasma concentration-time curve from time zero to infinite time.
Time Frame Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Darunavir 800 mg (FDC: Darunavir 800/Cobicistat 150 mg) Cobicistat 150 mg (FDC: Darunavir 800/Cobicistat 150 mg)
Hide Arm/Group Description:
Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) once orally on Day 1.
Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) once orally on Day 1.
Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
51460  (15836) 5710  (3128)
6.Primary Outcome
Title Elimination Rate Constant (Lambda[z])
Hide Description 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.
Time Frame Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Darunavir 800 mg (FDC: Darunavir 800/Cobicistat 150 mg) Cobicistat 150 mg (FDC: Darunavir 800/Cobicistat 150 mg)
Hide Arm/Group Description:
Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) once orally on Day 1.
Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) once orally on Day 1.
Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: per hour (1/h)
0.173  (0.0668) 0.199  (0.0233)
7.Primary Outcome
Title Terminal Elimination Half-Life (t1/2)
Hide Description 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).
Time Frame Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Darunavir 800 mg (FDC: Darunavir 800/Cobicistat 150 mg) Cobicistat 150 mg (FDC: Darunavir 800/Cobicistat 150 mg)
Hide Arm/Group Description:
Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) once orally on Day 1.
Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) once orally on Day 1.
Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: Hour
4.4  (1.4) 3.5  (0.4)
8.Primary Outcome
Title Apparent Volume of Distribution (Vz/F)
Hide Description Vz/F is defined as the apparent volume of distribution at the terminal phase after extravascular administration.
Time Frame Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Darunavir 800 mg (FDC: Darunavir 800/Cobicistat 150 mg) Cobicistat 150 mg (FDC: Darunavir 800/Cobicistat 150 mg)
Hide Arm/Group Description:
Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) once orally on Day 1.
Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) once orally on Day 1.
Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: milliliter (mL)
111970  (61217) 166460  (76366)
9.Primary Outcome
Title Apparent Total Body Clearance of Drug at the Terminal Phase After Extravascular Administration (CL/F)
Hide Description CL/F is the apparent total body clearance of drug at the terminal phase after extravascular administration.
Time Frame Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Darunavir 800 mg (FDC: Darunavir 800/Cobicistat 150 mg) Cobicistat 150 mg (FDC: Darunavir 800/Cobicistat 150 mg)
Hide Arm/Group Description:
Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) once orally on Day 1.
Participants received darunavir 800 mg along with cobicistat 150 mg in a fixed-dose combination (FDC) as film-coated tablet formulation (PREZCOBIX) once orally on Day 1.
Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: milliliter per hour (mL/h)
16974  (5440) 33573  (16699)
10.Secondary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description 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.
Time Frame Up to approximately 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Darunavir 800 mg/Cobicistat 150 mg as FDC (Prezcobix)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: Participants
0
Time Frame Up to approximately 1 month
Adverse Event Reporting Description Safety analysis set included all participants who received the study drug.
 
Arm/Group Title Darunavir 800 mg/Cobicistat 150 mg as FDC (Prezcobix)
Hide Arm/Group Description 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.
All-Cause Mortality
Darunavir 800 mg/Cobicistat 150 mg as FDC (Prezcobix)
Affected / at Risk (%)
Total   0/8 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Darunavir 800 mg/Cobicistat 150 mg as FDC (Prezcobix)
Affected / at Risk (%)
Total   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Darunavir 800 mg/Cobicistat 150 mg as FDC (Prezcobix)
Affected / at Risk (%)
Total   0/8 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director, IDV Department
Organization: Janssen Pharmaceutical K.K.
Phone: 844-434-4210
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT03123848     History of Changes
Other Study ID Numbers: CR108319
TMC114FD1HTX4002 ( Other Identifier: Janssen Pharmaceutical K.K., Japan )
First Submitted: April 19, 2017
First Posted: April 21, 2017
Results First Submitted: May 15, 2018
Results First Posted: June 12, 2018
Last Update Posted: June 12, 2018