A Study to Assess Bioavailability & Food Effect of Different Liquid and Capsule Formulations of TMC435.
24 juni 2013 bijgewerkt door: Janssen R&D Ireland
A Phase I, Open-Label, Randomized, 3-Panel, 3-way Crossover Trial in Healthy Adult Subjects to Assess the Relative Bioavailability of TMC435 Following Administration of 2 Liquid Formulations or 2 Different Capsule Concept Formulations Compared ot the Phase III 150 mg Capsule, and to Assess the Effect of Food on the Bioavailability of TMC435 Following Administration of the Liquid Formulations.
The purpose of this study is to evaluate the relative bioavailability and the short-term safety and tolerability of TMC435 following administration of 3 single oral doses of 150 mg, given as different formulations in healthy adult participants.
In addition, this study is to assess for the acceptability of the taste of both liquid formulations.
Studie Overzicht
Toestand
Voltooid
Conditie
Gedetailleerde beschrijving
TMC435 is being investigated for the treatment of chronic hepatitis C infection.
The current study is a Phase I, open-label (both participant and investigator know the name of the medication given at certain moment), randomized (study medication is assigned by chance) study designed to assess the relative bioavailability and food effect of 2 liquid formulations of TMC435, currently being developed for potential pediatric use, compared to the Phase III 150 mg capsule.
Also new capsule concept formulations will be investigated in comparison with the Phase III 150 mg capsule.
The study will be performed in healthy adult participants and is divided over 3 panels.
Participants will be randomized within a panel.
Each participant will receive 3 different treatments according to a classical 6-sequence, 3-period Williams design.
In Panel 1 and Panel 2, a single oral dose of 150 mg TMC435 oral suspension respectively with other strength will be compared with the capsule used in Phase III.
In Panel 3, two different capsule concept formulations will be compared with the capsule used in Phase III.
In panels containing the liquids, formulations will be compared under fasted and fed conditions to investigate the food effect.
In all treatments, the participants will receive medication on Day 1 of each treatment.
There will be a washout period of at least 7 days between subsequent treatments.
The main focus of the trial is the pharmacokinetic characteristics of all formulations (level-profile of TMC435 over time in the blood stream).
This evaluation requires multiple blood samples from Day 1 till Day 4 in each treatment.
Safety assessments (blood and urine tests, blood pressure, pulse, electrocardiogram, and physical examination) will follow a different schedule and will be evaluated from signing of the Informed Consent Form onwards until the last trial-related visit throughout the study.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
72
Fase
- Fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Harrow, Verenigd Koninkrijk
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 55 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Healthy volunteers should be healthy on the basis of physical examination, medical history, laboratory tests, 12-lead electrocardiogram and vital signs, performed at screening, have a body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg/m2, extremes included and be non-smoking for at least 3 months prior to screening.
- Women must be postmenopausal for at least 2 years and/or surgically sterile or not heterosexually active for duration of the trial.
Exclusion Criteria:
- All participants with known allergies, hypersensitivity or intolerance to TMC435 or any of the excipients.
- Use of concomitant medication, including over the counter products, herbal medication and dietary supplements, except for paracetamol (acetaminophen) or ibuprofen.
- Any condition that, in the opinion of the investigator, would compromise the study or well-being of the participant or prevent the subject from meeting or performing study requirements.
- History or suspicion of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use, which in investigator's opinion would compromise participant's safety and/or compliance with the trial procedures.
- Participation in an investigational drug trial with TMC435.
- Infected with HIV or Hepatitic A, B or C.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Treatment A
Panel 1: single oral dose of 150 mg TMC435 150 mg capsule, fed
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single oral dose of 150 mg TMC435 150 mg capsule
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Experimenteel: Treatment B
Panel 1: single oral dose of 150 mg TMC435 oral suspension (20 mg/mL), fasted
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single oral dose of 150 mg TMC435 oral suspension
Andere namen:
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Experimenteel: Treatment C
Panel 1: single oral dose of 150 mg TMC435 oral suspension (20 mg/mL), fed
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single oral dose of 150 mg TMC435 oral suspension
Andere namen:
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Experimenteel: Treatment D
Panel 2: single oral dose of 150 mg TMC435 150 mg capsule, fed
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single oral dose of 150 mg TMC435 150 mg capsule
Andere namen:
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Experimenteel: Treatment E
Panel 2: single oral dose of 150 mg TMC435 oral solution (10 mg/mL), fasted
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single oral dose of 150 mg TMC435 oral solution
Andere namen:
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Experimenteel: Treatment F
Panel 2: single oral dose of 150 mg TMC435 oral solution (10 mg/mL), fed
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single oral dose of 150 mg TMC435 oral solution
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Experimenteel: Treatment G
Panel 3: single oral dose of 150 mg TMC435 150 mg capsule, fed
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single oral dose of 150 mg TMC435 150 mg capsule
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Experimenteel: Treatment H
Panel 3: single oral dose of 150 mg TMC435 capsule concept K, fed
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single oral dose of 150 mg TMC435 capsule concept K
Andere namen:
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Experimenteel: Treatment I
Panel 3: single oral dose of 150 mg TMC435 capsule concept L, fed
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single oral dose of 150 mg TMC435 capsule concept L
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Comparing the bioavailability of oral solution and oral suspension formulation with the capsule formulation of TMC435 (fed state)
Tijdsspanne: 4 days
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Comparing the rate and extent of absorption (bioavailability) of 2 different liquid formulations (oral suspension [150 mg ie, 20 mg/mL] and oral solution [150 mg ie, 10 mg/mL]) versus capsule formulation (150 mg) of TMC435, after a high-fat breakfast (fed state)
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4 days
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Comparing the bioavailability of oral solution and oral suspension formulation of TMC435 in fed and fasted state
Tijdsspanne: 4 days
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Comparing the rate and extent of absorption (bioavailability) of 2 different liquid formulations (oral suspension [150 mg ie, 20 mg/mL] and oral solution [150 mg ie, 10 mg/mL]) of TMC435 in fed state (high-fat breakfast) versus fasted state
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4 days
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Comparing the bioavailability of concept K capsule and concept L capsule formulation with the capsule formulation of TMC435 (fed state)
Tijdsspanne: 4 days
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Comparing the rate and extent of absorption (bioavailability) of 2 different capsule formulations (concept K capsule [150 mg] and concept L capsule [150 mg]) versus capsule formulation (150 mg) of TMC435 after a high-fat breakfast (fed state)
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4 days
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Number of participants with adverse events
Tijdsspanne: 18 days
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Adverse events, abnormal clinical laboratory findings, abnormalities assessed in vital signs examination, physical examination, ECG measurements were evaluated for safety and tolerability during the study
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18 days
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Acceptability of taste assessed by taste questionnaires
Tijdsspanne: Day 1 of Treatment B and E
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Taste Questionnaires used to assess taste acceptability of oral suspension and solution of TMC435 under fasted conditions.
Taste Questionnaire for adults: participant had to select appropriate choice (None, Weak, Moderate, Strong) for 3 different types of tastes "Sweetness, Bitterness, Flavour" and also select appropriate choice (Bad, Amost acceptable, Acceptable and Good) for the Overall taste.
For pediatric participants: fill the visual analog scale by selecting appropriate choice (Dislike it very much, Dislike it a little, Not sure, Like it a little and Like it very much)
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Day 1 of Treatment B and E
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 maart 2012
Primaire voltooiing (Werkelijk)
1 mei 2012
Studie voltooiing (Werkelijk)
1 mei 2012
Studieregistratiedata
Eerst ingediend
23 januari 2012
Eerst ingediend dat voldeed aan de QC-criteria
3 april 2012
Eerst geplaatst (Schatting)
5 april 2012
Updates van studierecords
Laatste update geplaatst (Schatting)
25 juni 2013
Laatste update ingediend die voldeed aan QC-criteria
24 juni 2013
Laatst geverifieerd
1 juni 2013
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CR100787
- TMC435HPC1002 (Andere identificatie: Janssen R&D Ireland)
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