A Study of Drug-drug Interaction Between Ritonavir and TMC435350 in Healthy Volunteers
11. oktober 2013 oppdatert av: Tibotec Pharmaceuticals, Ireland
Phase I, Open-label Trial in Healthy Subjects to Evaluate the Drug-drug Interaction Between Ritonavir at Steady-state and TMC435350, a Viral Protease Inhibitor Against Hepatitis C Virus, After the First and the Last Dose of a Multiple Dosing Regimen
The purpose of this study is to evaluate the drug-drug interaction between steady-state concentrations of CYP3A4 or ritonavir and TMC435350 after its first and the last dose of the multiple dosing regimen and to explore the short term safety and tolerability of multiple doses of 200 mg of TMC435350 administered alone and in combination with 100 mg of ritonavir.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This trial is a Phase I, open label trial (meaning that both the research physician and study participants will know which medication is being administered during the trial) in 12 healthy volunteers (referred to as participants) to investigate the effect of ritonavir, a marketed product used in several HIV medications, on the plasma levels of TMC435350, a new investigational drug in process of development for the treatment of hepatitis-C virus (HCV) infections.
TMC435350 is a protease inhibitor (PI), a class of drugs that selectively inhibit the replication of the virus thereby inhibiting the progression of HCV infection.
Plasma levels of TMC435350 are circulating levels of TMC435350 in the blood that are important for the antiviral activity of TMC435350.
Ritonavir has the ability to increase the circulating levels of other compounds administered on the same day as Ritonavir.
The trial will consist of 2 sequential sessions (Session 1 and Session 2) and all participants enrolled in the study will enter each session.
In Session 1, participants will take TMC435350 200mg orally (by mouth) once daily for 7 days.
There will be a waiting period of at least 7 days to allow any drug left in the body after the last treatment in Session 1 to be eliminated before the start of Session 2 (referred to as a "washout period").
In Session 2, participants will take ritonavir 100 mg orally twice daily on Days 1 to 15 and TMC435350 200mg once daily on Days 6 to 12.
All study drugs in both treatment sessions will be taken under fed conditions (i. e., participants will eat a standard breakfast within approximately 30 minutes before they take study drug).
Full pharmacokinetic profiles of TMC435350 (to investigate how the drug moves through the body, including the absorption, distribution, metabolism and elimination of the drug) will be determined from blood samples obtained on Days 1 and 7 of Session 1 and on Days 6 and 12 of Session 2. Safety and tolerability will be recorded continuously.
The total duration of treatment in the study for each participant will be approximately 30 days (includes 7 days of treatment in Session 1, 16 days of treatment in Session 2, and a washout period of at least 7 days between treatment sessions).
Studietype
Intervensjonell
Registrering (Faktiske)
12
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Aalst, Belgia
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 55 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Mann
Beskrivelse
Inclusion Criteria:
non-smoking for at least 3 months prior to selection
- normal weight as defined by a Quetelet Index (Body Mass Index: weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg/m2, extremes included
- Informed Consent Form signed voluntarily, prior to the first trial related activity
- normal 12-lead electrocardiogram (ECG) at screening
- healthy on the basis of a medical evaluation and results fo the laboratory tests at screening.
Exclusion Criteria:
past history of heart arrhythmias,
- female, except if postmenopausal for more than two years, or post-hysterectomy or post-tubal ligation (without reversal operation)
- history or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use
- hepatitis A, B and C infections or human immunodeficiency virus type 1 (HIV-1) or HIV-2 infections at study screening
- donation of blood or plasma in the 60 days preceding the first intake of trial medication
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: TMC435350 / Ritonavir
TMC435350 2 capsules of 100-mg twice daily / Ritonavir one 100-mg capsule twice daily
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Each patient will receive 200 mg (2 capsules) once daily orally from Day 1 to Day 7 in Session 1 and from Day 6 to Day 12 in Session 2
Each patient will receive 100 mg (1 capsule) of ritonavir twice daily orally from Day 1 until Day 15 of Session 2
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Plasma concentration of TMC435350
Tidsramme: Days 1 and 7 of Session 1
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In Session 1, the plasma concentration of TMC435350 is measured in the absence of ritonavir.
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Days 1 and 7 of Session 1
|
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Plasma concentration of TMC435350
Tidsramme: Days 6 and 16 of Session 2
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In Session 2, the plasma concentration of TMC435350 is measured in the presence of ritonavir.
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Days 6 and 16 of Session 2
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of patients reporting adverse events (AEs) as a measure of safety and tolerability
Tidsramme: Up to approximately 86 days
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Adverse events will be reported from the time the participant signs the Informed Consent Form (ICF) up to the completion of the last trial-related visit which will be approximately 86 days (includes up to 21 days during the screening period, 7 days during treatment session 1, at least 7 days between treatment sessions, 16 days during treatment session 2, and for up to 35 days after the last dose in treatment session 2).
The incidence of AEs under Session 1 will be compared with the incidence of AEs under session 2
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Up to approximately 86 days
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. oktober 2007
Primær fullføring (Faktiske)
1. januar 2008
Studiet fullført (Faktiske)
1. januar 2008
Datoer for studieregistrering
Først innsendt
28. juni 2013
Først innsendt som oppfylte QC-kriteriene
28. juni 2013
Først lagt ut (Anslag)
3. juli 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
14. oktober 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. oktober 2013
Sist bekreftet
1. oktober 2013
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CR014773
- TMC435350-TiDP16-C104 (Annen identifikator: Tibotec Pharmaceuticals Limited, Ireland)
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