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Trial record 82 of 913 for:    tablet | Japan

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.

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Darunavir/Cobicistat Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : April 14, 2017
Actual Primary Completion Date : May 19, 2017
Actual Study Completion Date : May 19, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Darunavir/Cobicistat FDC (Prezcobix)
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.
Drug: Darunavir/Cobicistat
Participants will receive a FDC tablet of darunavir 800 mg and cobicistat 150 mg orally in the morning of Day 1.
Other Name: TMC114/JNJ-48763364-AAA




Primary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) [ 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 ]
    The Cmax is the maximum observed plasma concentration.

  2. Concentration at Last Quantifiable Time Point (Clast) [ 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 ]
    Clast is defined as concentration at last quantifiable time point.

  3. Time to Reach the Maximum Plasma Concentration (Tmax) [ 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 ]
    Tmax is defined as the time to reach the maximum plasma concentration.

  4. Area Under the Plasma Concentration-Time Curve From Time Zero to Time the Last Quantifiable Time (AUC[0-last]) [ 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 ]
    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.

  5. Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC0-infinity) [ 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 ]
    AUC(0-infinity) is defined as area under the plasma concentration-time curve from time zero to infinite time.

  6. Elimination Rate Constant (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 ]
    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.

  7. Terminal Elimination Half-Life (t1/2) [ 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 ]
    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).

  8. Apparent Volume of Distribution (Vz/F) [ 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 ]
    Vz/F is defined as the apparent volume of distribution at the terminal phase after extravascular administration.

  9. Apparent Total Body Clearance of Drug at the Terminal Phase After Extravascular Administration (CL/F) [ 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 ]
    CL/F is the apparent total body clearance of drug at the terminal phase after extravascular administration.


Secondary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) [ Time Frame: Up to approximately 1 month ]
    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.



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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03123848


Locations
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Japan
Souseikai Hakata Clinic
Fukuoka, Japan, 8120025
Sponsors and Collaborators
Janssen Pharmaceutical K.K.
Investigators
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Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial Janssen Pharmaceutical K.K.
  Study Documents (Full-Text)

Documents provided by Janssen Pharmaceutical K.K.:
Study Protocol  [PDF] February 3, 2017
Statistical Analysis Plan  [PDF] July 7, 2017


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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 Posted: April 21, 2017    Key Record Dates
Results First Posted: June 12, 2018
Last Update Posted: June 12, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Darunavir
Cobicistat
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors