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A Study to Evaluate the Pharmacokinetics of Rilpivirine/Tenofovir/Emtricitabine After a Single-Oral Administration in Healthy Japanese Adult Male Participants

30. december 2016 opdateret af: Janssen Pharmaceutical K.K.

An Open-Label Study to Evaluate the Pharmacokinetics of Rilpivirine/Tenofovir/Emtricitabine After a Single-Oral Administration of a Rilpivirine/Tenofovir Disoproxil Fumarate/Emtricitabine Fixed-Dose Combination Tablet in Healthy Japanese Adult Male Subjects

The purpose of this study is to evaluate the pharmacokinetics (PK) of rilpivirine/Tenofovir/Emtricitabine (RPV/TFV/FTC) after a single-oral administration of Complera (the fixed-dose combination of RPV, FTC, Tenefovir disoproxil fumarate [TDF]) to healthy Japanese adult male participants.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

This is a single center, open-label, single oral dose study in healthy Japanese adult male participants. The study consists of 3 phases; a screening phase up to 27 days (Day -28 to Day -2), an in-patient phase from Day -1 to Day 3 (dosing day is Day 1), and a follow-up assessment phase from Day 4 to the last follow-up assessment scheduled on Day 15 or at the time of early withdrawal. All participants will receive a single oral dose of one Complera tablet on Day 1 within 5 minutes after completion of the standardized breakfast. Pharmacokinetics of RPV/TFV/FTC will be assessed as the primary objective of the study. Safety of each participant will be assessed throughout the study.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

8

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år til 55 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Han

Beskrivelse

Inclusion Criteria:

  • Willing to adhere to the prohibitions and restrictions specified in this protocol
  • Participant who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control eg, either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 3 months after receiving the dose of study drug
  • Body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m^2) (inclusive), and body weight not less than 50 kg
  • Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeters of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic
  • Non-smoker 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 first study drug administration

Exclusion Criteria:

  • 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, hepatic or renal insufficiency (creatinine clearance below 60 mL/min), thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
  • Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or at admission to the study center as deemed appropriate by the investigator
  • Clinically significant abnormal physical examination, vital signs, or 12 lead electrocardiogram (ECG) at screening or at admission to the study center as deemed appropriate by the investigator
  • Use of any prescription or nonprescription medication (including vitamins and herbal supplements) within 14 days before the first dose of the study drug is scheduled until completion of the study
  • History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (4th edition text revision or 5th edition) (DSM-IV or DSM-5) criteria or International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10) criteria within 5 years before screening or positive test result(s) for alcohol and/or drugs of abuse (such as benzodiazepines, cocaines, stimulants, cannabinoids, barbiturates, opiates, phencyclidines, and tricyclic antidepressants) at screening and on Day -1

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Rilpivirine/Tenofovir Disoproxil Fumarate/Emtricitabine
Participants will receive single oral dose of fixed dose combination (FDC) tablet comprising of Rilpivirine/Tenofovir Disoproxil Fumarate/Emtricitabine on Day 1.
Fixed dose combination tablet contains 25 milligram (mg) of Rilpivirine, 300 mg of Tenofovir Disoproxil Fumarate (TDF) and 200 mg of Emtricitabine (FTC).
Andre navne:
  • Complera

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maximum Observed Plasma Concentration (Cmax)
Tidsramme: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours post-dose
The Cmax is the maximum observed plasma concentration of rilpivirine, tenofovir, emtricitabine.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Tidsramme: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours post-dose
The Tmax is defined as actual sampling time to reach maximum observed analyte (rilpivirine/tenofovir/emtricitabine) concentration.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours post-dose
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last])
Tidsramme: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours post-dose
The AUC (0-last) is the area under the plasma concentration-time curve for rilpivirine/tenofovir/emtricitabine from time zero to last quantifiable time.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours post-dose
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
Tidsramme: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours post-dose
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours post-dose
Elimination Rate Constant (Lambda[z])
Tidsramme: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours post-dose
Lambda(z) is first-order elimination 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.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours post-dose
Elimination Half-Life (t1/2)
Tidsramme: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours post-dose
The elimination half-life (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).
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours post-dose
Apparent Volume of Distribution (Vdz/F)
Tidsramme: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours post-dose
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vdz/F) is influenced by the fraction absorbed.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours post-dose
Apparent Clearance (CL/F)
Tidsramme: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours post-dose
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours post-dose

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants who Experience Adverse Events
Tidsramme: Up to 17 days following study drug administration
As a measure of safety and tolerability.
Up to 17 days following study drug administration

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2015

Primær færdiggørelse (Faktiske)

1. september 2015

Studieafslutning (Faktiske)

1. september 2015

Datoer for studieregistrering

Først indsendt

19. august 2015

Først indsendt, der opfyldte QC-kriterier

19. august 2015

Først opslået (Skøn)

20. august 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

2. januar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. december 2016

Sidst verificeret

1. december 2016

Mere information

Begreber relateret til denne undersøgelse

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Rilpivirine/Tenofovir Disoproxil Fumarate/Emtricitabine FDC

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