- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01253551
VX-950HEP1001 - Drug-drug Interaction Study Between Telaprevir and Raltegravir
13. Oktober 2012 aktualisiert von: Tibotec BVBA
A Phase 1, Open-label, Randomized, Crossover Study in 20 Healthy Subjects to Investigate the Potential Pharmacokinetic Interaction Between Telaprevir and Raltegravir, Both at Steady-state
The purpose of this study is to confirm the absence of a clinically relevant interaction between telaprevir and raltegravir at steady-state.Telaprevir is being investigated for the treatment of chronic hepatitis C virus infection, and raltegravir is used to treat HIV infection.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This is an open-label, randomized (the order in which you receive the treatment sessions is determined by chance, like tossing a coin), crossover (participants will receive different interventions sequentially during the trial) study in healthy participants to investigate the effect of telaprevir 750 mg, every 8 hours, on the pharmacokinetics (how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body) of raltegravir 400 mg, twice a day, and vice versa.
The study population will consist of 20 healthy participants.
Each individual participant will receive two treatments: Treatment A (telaprevir 750 mg, every 8 hours, alone, on Days 1 to 6, with a morning dose on Day 7) and Treatment B (raltegravir 400 mg, twice a day, on Days 1 to 10 and telaprevir 750 mg, every 8 hours, on Days 5 to 10, with a morning dose of raltegravir, and a morning and afternoon dose of telaprevir on Day 11).
Half of the participants will receive first Treatment A and then Treatment B; the other half will receive first Treatment B and then Treatment A. There will be a washout period of at least 14 days between the 2 sessions.
The screening period will be maximum 21 days; the treatment duration will be approximately 4.5 weeks, and the follow-up period will be 30 to 31 days.
All study medication will be taken with food.
On Day 7 of Treatment A and Day 11 of Treatment B, 9 blood samples will be taken for determination of the levels of telaprevir in the blood.
On Days 4 and 11 of Treatment B, 10 blood samples will be taken for determination of the levels of raltegravir in the blood.
Predose pharmacokinetic samples will be collected on other days during the treatment sessions.
Safety and tolerability will be evaluated throughout the trial by evaluating results of blood and urine analyses, vital signs, physical examinations, electrocardiograms (electrical recording of the heart), drug and alcohol screenings, and by assessing how the participant is feeling.
In Treatment A, participants will receive 2 oral tablets of telaprevir 375 mg every 8 hours on Days 1 to 6, with a morning dose on Day 7. In Treatment B, participants will receive 1 oral tablet of 400 mg raltegravir twice a day on Days 1 to 10 and 2 oral tablets of 375 mg telaprevir every 8 hours on Days 5 to 10, with a morning dose of raltegravir, and a morning and afternoon dose of telaprevir on Day 11.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
21
Phase
- Phase 1
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 55 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- Healthy on the basis of physical examination, medical history, vital signs, electrocardiogram and clinical laboratory tests at screening
- A Body Mass Index of 18.0 to 30.0 kg/m2, extremes included
- Women must be postmenopausal for at least 2 years, be surgically sterile and should not be breastfeeding
- Men must agree to use 2 highly effective methods of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of the study drug
- Be non-smoking for at least 3 months prior to selection.
Exclusion Criteria:
- Current use of prescription medication, regular treatment with over-the-counter medications (to be stopped no less than 7 days prior to first intake of study medication) or consumption of herbal medications or dietary supplements, vitamins, grapefruit or grapefruit juice, apple juice or orange juice within 14 days before first intake of study medication
- Consumption of more than 2 units of alcoholic beverages per day or more than 14 units per week (1 unit of alcohol equals 1 glass of beer, 1 glass of wine, 25 mL shot of 40% spirit), consumption of alcohol 72 hours before or after study medication intake, consumption of an average of more than five 240 mL servings of coffee or other caffeinated beverages, eg, tea, cola per day
- History or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use
- Received an investigational drug or vaccine or used an investigational medical device within 3 months or 5 half lives (whichever is longer) before the planned start of treatment or having participated previously in a study with telaprevir.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 001
Treatment sequence AB Treatment A: telaprevir 750 mg every 8 hours on Days 1 to 6 with a morning dose on Day 7. Treatment B: raltegravir 400 mg twice a day on Days 1 to 10 and telaprevir 750 mg every 8 hours on Days 5 to 10 with a morning dose of raltegravir and a morning and afternoon dose of telaprevir on Day 11.
|
Treatment A: telaprevir 750 mg every 8 hours on Days 1 to 6, with a morning dose on Day 7. Treatment B: raltegravir 400 mg twice a day on Days 1 to 10 and telaprevir 750 mg every 8 hours on Days 5 to 10, with a morning dose of raltegravir, and a morning and afternoon dose of telaprevir on Day 11.
|
Experimental: 002
Treatment sequence BA Treatment A: telaprevir 750 mg every 8 hours on Days 1 to 6 with a morning dose on Day 7. Treatment B: raltegravir 400 mg twice a day on Days 1 to 10 and telaprevir 750 mg every 8 hours on Days 5 to 10 with a morning dose of raltegravir and a morning and afternoon dose of telaprevir on Day 11.
|
Treatment A: telaprevir 750 mg every 8 hours on Days 1 to 6, with a morning dose on Day 7. Treatment B: raltegravir 400 mg twice a day on Days 1 to 10 and telaprevir 750 mg every 8 hours on Days 5 to 10, with a morning dose of raltegravir, and a morning and afternoon dose of telaprevir on Day 11.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Blood levels of telaprevir and raltegravir when given alone versus when given together
Zeitfenster: Day 7 of Treatment A
|
Day 7 of Treatment A
|
Blood levels of telaprevir and raltegravir when given alone versus when given together
Zeitfenster: Day 4 of Treatment B
|
Day 4 of Treatment B
|
Blood levels of telaprevir and raltegravir when given alone versus when given together
Zeitfenster: Day 11 of Treatment B
|
Day 11 of Treatment B
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Percentage of participants with a given adverse event as a measure of safety and tolerability
Zeitfenster: From screening to end of study
|
From screening to end of study
|
Clinical laboratory abnormalities as a measure of safety and tolerability
Zeitfenster: At screening and at 5-7 days and 30-32 days after last dose (Treatment A or B)
|
At screening and at 5-7 days and 30-32 days after last dose (Treatment A or B)
|
Clinical laboratory abnormalities as a measure of safety and tolerability
Zeitfenster: On Days 1 and 7 (Treatment A)
|
On Days 1 and 7 (Treatment A)
|
Clinical laboratory abnormalities as a measure of safety and tolerability
Zeitfenster: On Days 1, 4, and 11 (Treatment B)
|
On Days 1, 4, and 11 (Treatment B)
|
Vital signs observed values and changes from baseline as a measure of safety and tolerability
Zeitfenster: At screening and at 5-7 days and 30-32 days after last dose (Treatment A or B)
|
At screening and at 5-7 days and 30-32 days after last dose (Treatment A or B)
|
Vital signs observed values and changes from baseline as a measure of safety and tolerability
Zeitfenster: On Days 1 and 7 (Treatment A)
|
On Days 1 and 7 (Treatment A)
|
Vital signs observed values and changes from baseline as a measure of safety and tolerability
Zeitfenster: On Days 1, 4, and 11 (Treatment B)
|
On Days 1, 4, and 11 (Treatment B)
|
Physical examination findings and changes from baseline as a measure of safety and tolerability
Zeitfenster: At screening, on Day -1 of Treatments A and B, and at 5-7 days and 30-32 days after last dose (Treatment A or B)
|
At screening, on Day -1 of Treatments A and B, and at 5-7 days and 30-32 days after last dose (Treatment A or B)
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Dezember 2010
Studienabschluss (Tatsächlich)
1. April 2011
Studienanmeldedaten
Zuerst eingereicht
2. Dezember 2010
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
2. Dezember 2010
Zuerst gepostet (Schätzen)
3. Dezember 2010
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
16. Oktober 2012
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
13. Oktober 2012
Zuletzt verifiziert
1. Oktober 2012
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CR017608
- VX-950HEP1001
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