A Study to Assess the Bioequivalence of Darunavir When Co-Administrated With Cobicistat Under Fed and Fasted Conditions
1. marts 2013 opdateret af: Janssen R&D Ireland
A Single-Dose, Open-Label, 3-Panel, Randomized, Pivotal Crossover Study to Assess the Bioequivalence of Darunavir When Co-Administrated With Cobicistat as Either a Fixed Dose Combination Tablet (G006) or as Single Agents Under Fed and Fasted Conditions in Healthy Subjects
The purpose of this study is to evaluate the single-dose pharmacokinetics and bioequivalence of darunavir 800 mg when administered as a fixed dose combination relative to 2 x 400 mg tablets of the commercial tablet formulation, in the presence of 150 mg cobicistat, (under fed and fasted conditions) in healthy participants.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is a randomized (the study drug is assigned by chance), open-label (all people know the identity of the intervention), 3-panel, single-center, single-dose, crossover (method used to switch patients from one treatment arm to another in a clinical trial) study in 134 healthy adult participants.
The study consists of 3 phases including a screening phase of approximately 3 weeks (Days -21 to -1) followed by an open-label treatment phase consisting of 3 panels with 2 single-dose treatment sessions of 5 days each (Days -1 to 4) separated by a washout period of at least 7 days, and a follow-up period occurring 7 to 10 days after last intake of study drugs.
The study consists of 3 panels.
In each panel participants will be randomly be assigned to 1 of 2 treatment sequences (AB or BA for Panel 1; CD or DC for Panel 2; and EF or FE for Panel 3).
Participants will receive either single-dose darunavir 800 mg as 2 x 400 mg tablets and cobicistat 150 mg tablet or single-dose darunavir/cobicistat 800/150 mg as tablet in each panel (under fed and fasted conditions).
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
133
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Merksem, Belgien
-
-
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
18 år til 60 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Participant should be healthy on the basis of physical examination, medical history, vital signs, and electrocardiogram and clinical laboratory tests performed at screening
- Have a Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.5 to 30.0 kg/m2, extremes included
- Men and women must agree to use a highly effective method of birth control
Exclusion Criteria:
- Has a positive HIV-1 or HIV-2 test at screening
- Has a Hepatitis A, B or C infection (confirmed by hepatitis A antibody immunoglobulin M (IgM), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody, respectively) at screening
- Has any history of renal insufficiency
- Has a history of significant skin reactions or any history of allergies to drugs
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: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Treatment A
Single-dose co-administration of 800 mg darunavir and 150 mg cobicistat as single agents (under fasted condition)
|
Type=exact number, unit=mg, number=400, form=tablet, route=oral.
Two tablets as a single dose or a tablet in combination with cobicistat
Type=exact number, unit=mg, number=150, form=tablet, route=oral.
One tablet as a single dose or a tablet in combination with darunavir
|
|
Eksperimentel: Treatment B
Single-dose co-administration of the fixed dose combination darunavir/cobicistat (800/150-mg) (under fasted condition).
|
Type=exact number, unit=mg, number=400, form=tablet, route=oral.
Two tablets as a single dose or a tablet in combination with cobicistat
Type=exact number, unit=mg, number=150, form=tablet, route=oral.
One tablet as a single dose or a tablet in combination with darunavir
|
|
Eksperimentel: Treatment C
Single-dose co-administration of 800 mg darunavir and 150 mg cobicistat as single agents (under fed condition - standardized breakfast).
|
Type=exact number, unit=mg, number=400, form=tablet, route=oral.
Two tablets as a single dose or a tablet in combination with cobicistat
Type=exact number, unit=mg, number=150, form=tablet, route=oral.
One tablet as a single dose or a tablet in combination with darunavir
|
|
Eksperimentel: Treatment D
Single-dose co-administration of the fixed dose combination darunavir/cobicistat (800/150-mg) (under fed condition - standardized breakfast).
|
Type=exact number, unit=mg, number=400, form=tablet, route=oral.
Two tablets as a single dose or a tablet in combination with cobicistat
Type=exact number, unit=mg, number=150, form=tablet, route=oral.
One tablet as a single dose or a tablet in combination with darunavir
|
|
Eksperimentel: Treatment E
Single-dose co-administration of the fixed dose combination darunavir/cobicistat 800/150-mg (under fasted condition).
|
Type=exact number, unit=mg, number=400, form=tablet, route=oral.
Two tablets as a single dose or a tablet in combination with cobicistat
Type=exact number, unit=mg, number=150, form=tablet, route=oral.
One tablet as a single dose or a tablet in combination with darunavir
|
|
Eksperimentel: Treatment F
Single-dose co-administration of the fixed dose combination darunavir/cobicistat (800/150-mg) (under fed condition - high-fat breakfast).
|
Type=exact number, unit=mg, number=400, form=tablet, route=oral.
Two tablets as a single dose or a tablet in combination with cobicistat
Type=exact number, unit=mg, number=150, form=tablet, route=oral.
One tablet as a single dose or a tablet in combination with darunavir
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Comparison of maximum plasma analyte concentration (Cmax) of darunavir as a fixed dose combination relative to 2 tablets of darunavir (400 mg), in the presence of cobicistat (150 mg)
Tidsramme: Up to 27 Days
|
The pharmacokinetic parameter (Cmax) of darunavir will be compared as a fixed dose combination relative to 2 tablets of darunavir (400 mg), in the presence of cobicistat (150 mg).
|
Up to 27 Days
|
|
Comparison of last observed measurable analyte concentration (Clast) of darunavir as a fixed dose combination relative to 2 tablets of darunavir (400 mg), in the presence of cobicistat (150 mg)
Tidsramme: Up to 27 Days
|
The pharmacokinetic parameter (Clast) of darunavir will be compared as a fixed dose combination relative to 2 tablets of darunavir (400 mg), in the presence of cobicistat (150 mg).
|
Up to 27 Days
|
|
Comparison of actual sampling time to reach the maximum plasma analyte concentration (tmax) of darunavir as a fixed dose combination relative to 2 tablets of darunavir (400 mg), in the presence of cobicistat (150 mg)
Tidsramme: Up to 27 Days
|
The pharmacokinetic parameter (tmax) of darunavir will be compared as a fixed dose combination relative to 2 tablets of darunavir (400 mg), in the presence of cobicistat (150 mg) for assessment of bioequivalance.
|
Up to 27 Days
|
|
Area under curve from time of administration up to the last time point with a measurable plasma analyte concentration (AUClast) of darunavir as a fixed dose combination relative to 2 tablets of darunavir (400 mg), in the presence of cobicistat (150 mg)
Tidsramme: Up to 27 Days
|
The pharmacokinetic parameter (AUClast) of darunavir will be compared as a fixed dose combination relative to 2 tablets of darunavir (400 mg), in the presence of cobicistat (150 mg).
|
Up to 27 Days
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of participants with adverse events as a measure of safety and tolerabilty
Tidsramme: Up to 27 Days
|
Safety and tolerability of darunavir/cobicistat co-administration in healthy participants will be assessed by number of participants with adverse events.
|
Up to 27 Days
|
|
Evaluation of plasma pharmacokinetics of cobicistat with darunavir when both administered as a fixed dose combination tablet
Tidsramme: Up to 27 Days
|
Plasma pharmacokinetics of cobicistat with darunavir when both administered as a fixed dose combination tablet under fed conditions in healthy participants will be evaluated.
|
Up to 27 Days
|
|
Evaluation of plasma pharmacokinetics of cobicistat with darunavir when both administered as a single agents
Tidsramme: Up to 27 Days
|
Plasma pharmacokinetics of cobicistat with darunavir when both administered as a single agents under fed conditions in healthy participants will be evaluated.
|
Up to 27 Days
|
|
Evaluation of plasma pharmacokinetics of cobicistat with darunavir when both administered as a fixed dose combination tablet
Tidsramme: Up to 27 Days
|
Plasma pharmacokinetics of cobicistat with darunavir when both administered as a fixed dose combination tablet under fasted conditions in healthy participants will be evaluated.
|
Up to 27 Days
|
|
Evaluation of plasma pharmacokinetics of cobicistat with darunavir when both administered as a single agents
Tidsramme: Up to 27 Days
|
Plasma pharmacokinetics of cobicistat with darunavir when both administered as a single agents under fasted conditions in healthy participants will be evaluated
|
Up to 27 Days
|
|
Evaluation of effect of a high-fat meal on darunavir and cobicistat pharmacokinetics relative to the fasted state
Tidsramme: Up to 27 Days
|
Effects of a high-fat meal on darunavir and cobicistat pharmacokinetics relative to the fasted state will be evaluated.
|
Up to 27 Days
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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. april 2012
Primær færdiggørelse (Faktiske)
1. august 2012
Studieafslutning (Faktiske)
1. august 2012
Datoer for studieregistrering
Først indsendt
12. juni 2012
Først indsendt, der opfyldte QC-kriterier
13. juni 2012
Først opslået (Skøn)
14. juni 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
4. marts 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. marts 2013
Sidst verificeret
1. marts 2013
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Ernæringsforstyrrelser
- Fejlernæring
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Antivirale midler
- Enzymhæmmere
- Anti-HIV-midler
- Anti-retrovirale midler
- Proteasehæmmere
- Cytokrom P-450 CYP3A-hæmmere
- Cytokrom P-450 enzymhæmmere
- HIV-proteasehæmmere
- Virale proteasehæmmere
- Cobicistat
- Darunavir
Andre undersøgelses-id-numre
- CR100699
- TMC114IFD1003 (Anden identifikator: Janssen R&D Ireland)
- 2012-000273-23 (EudraCT nummer)
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