TMC435-TiDP16-C116 - Relative Bioavailability and Food Effect Study
10 oktober 2012 bijgewerkt door: Tibotec Pharmaceuticals, Ireland
A Phase I, Open-label, Randomized, Single-dose, 2-panel, Crossover Trial in Healthy Subjects to Assess the Relative Bioavailability of TMC435 HPMC Capsule Compared to the TMC435 Gelatin Capsule and to Assess the Effect of Different Meal Types on the Bioavailability of Both Formulations
The purpose of this study is to compare absorption of TMC435 formulated as 2 different types of capsules.
After that, the absorption of one chosen TMC435 capsule will be compared when taken under fasting conditions or together with a standard or a high-fat meal.
This will be done in healthy volunteers.
Studie Overzicht
Toestand
Voltooid
Conditie
Gedetailleerde beschrijving
This is an open-label, randomized, single-dose, crossover trial in healthy volunteers.
Crossover means that participants may receive different interventions sequentially during the trial.
Randomized means that you will be assigned to a treatment sequence by chance, like flipping a coin.
Open-label means that you and your physician will know what treatment you will receive.
The study will consist of 3 phases: a screening phase, a treatment phase and a follow-up phase.
Total study duration for an individual participant will be up to 6 or 7 weeks.
Once found eligible after the screening phase, participants will take part in one of the two parts of the treatment phase.
In the first part, a group of 24 participants will receive two treatment sessions, A and B. The order in which the treatments are given will be determined by chance.
Treatment A is a single dose of TMC345 as one formulation (1 capsule).
Treatment B is a single dose of TMC435 as another formulation (1 other type of capsule).
Both treatments will be taken without food.
In between the 2 sessions, there will be at least 7 days.
In the second part, another group of 24 participants will receive 3 treatment sessions, C, D, and E. The order in which these treatments are given will be determined by chance.
All 3 treatments will consist of a single dose of TMC435 as one of the 2 formulations given in the first part.
In Treatment C this will be given without food, in Treatment D with a standardized breakfast and in Treatment E with a high-fat breakfast.
In between the sessions, there will be at least 7 days.
For all treatment sessions, participants will enter the study center the day before dosing and will remain there until the evening of the day after.
The 3 following mornings, participants will come back to the study center.
Five to 7 days after dosing, participants will have a last follow-up visit at the study center (follow-up phase).
During the study, safety will be monitored, and during the treatment phase, at specified timepoints, blood samples will be taken for pharmacokinetic evalutions (effect of the body on the drug).
In every treatment session, a single oral 150 mg TMC435 capsule will be given.
One formulation will be a gelatin capsule.
The other formulation will be a hydroxypropylmethylcellulose (HPMC) capsule.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
48
Fase
- Fase 1
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
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Non-smokers for at least 3 months prior to screening
- Have a body mass index of 18.0 to 30.0 kg per square meter
- Be healthy on the basis of physical examination, medical history, vital signs, and clinical laboratory tests performed at screening
Exclusion Criteria:
- Use of disallowed therapies, including over-the-counter products and dietary supplements
- Having previously participated in a multiple-dose trial or more than 3 single-dose trials with TMC435
- Received an investigational drug or used an investigational medical device within 90 days before the planned start of treatment
- History or evidence of current use of alcohol, barbiturate, amphetamine, recreational, or narcotic drug use
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 |
|---|---|
|
Experimenteel: 001
TMC435 gelatin capsule Single intake of one 150-mg capsule without food
|
Single intake of one 150-mg capsule without food
|
|
Experimenteel: 002
TMC435 HPMC capsule Single intake of one 150-mg capsule without food
|
Single intake of one 150-mg capsule without food
|
|
Experimenteel: 003
TMC435 HPMC or gelatin capsule Single intake of one 150-mg capsule without food
|
Single intake of one 150-mg capsule after high-fat breakfast
Single intake of one 150-mg capsule without food
Single intake of one 150-mg capsule after standardized breakfast
|
|
Experimenteel: 004
TMC435 HPMC or gelatin capsule Single intake of one 150-mg capsule after standardized breakfast
|
Single intake of one 150-mg capsule after high-fat breakfast
Single intake of one 150-mg capsule without food
Single intake of one 150-mg capsule after standardized breakfast
|
|
Experimenteel: 005
TMC435 HPMC or gelatin capsule Single intake of one 150-mg capsule after high-fat breakfast
|
Single intake of one 150-mg capsule after high-fat breakfast
Single intake of one 150-mg capsule without food
Single intake of one 150-mg capsule after standardized breakfast
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Absorption of TMC435 following administration of the HPMC capsule and of the gelatin capsule
Tijdsspanne: Over 72 hours for every treatment session
|
Over 72 hours for every treatment session
|
|
Absorption of TMC435 following administration of the HPMC or gelatin capsule in the fed (following different meal types) and fasted state
Tijdsspanne: Over 72 hours for every treatment session
|
Over 72 hours for every treatment session
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Number of participants with adverse events and the severity of adverse events
Tijdsspanne: During maximum 7 weeks
|
During maximum 7 weeks
|
|
Percentage of abnormal values for laboratory parameters
Tijdsspanne: Up to maximum 7 weeks
|
Up to maximum 7 weeks
|
|
Observed values and changes from baseline of cardiovascular variables
Tijdsspanne: Up to maximum 7 weeks
|
Up to maximum 7 weeks
|
|
Evaluation of pulse and blood pressure values, based on changes from baseline and the percentage of participants with values beyond clinically important limits
Tijdsspanne: Up to maximum 7 weeks
|
Up to maximum 7 weeks
|
|
Physical examination findings and changes from baseline.
Tijdsspanne: Up to maximum 7 weeks
|
Up to maximum 7 weeks
|
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 2011
Studie voltooiing (Werkelijk)
1 juni 2011
Studieregistratiedata
Eerst ingediend
3 maart 2011
Eerst ingediend dat voldeed aan de QC-criteria
3 maart 2011
Eerst geplaatst (Schatting)
4 maart 2011
Updates van studierecords
Laatste update geplaatst (Schatting)
11 oktober 2012
Laatste update ingediend die voldeed aan QC-criteria
10 oktober 2012
Laatst geverifieerd
1 oktober 2012
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het spijsverteringsstelsel
- RNA-virusinfecties
- Virusziekten
- Infecties
- Door bloed overgedragen infecties
- Overdraagbare ziekten
- Lever Ziekten
- Flaviviridae-infecties
- Hepatitis, viraal, menselijk
- Hepatitis
- Hepatitis C
- Moleculaire mechanismen van farmacologische werking
- Anti-infectieuze middelen
- Antivirale middelen
- Enzymremmers
- Proteaseremmers
- Simeprevir
Andere studie-ID-nummers
- CR015940
- TMC435-TiDP16-C116
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