Safety, Pharmacokinetics, and Pharmacodynamics of MK-6325 in Hepatitis C Virus (HCV) Infections (MK-6325-003)
4 février 2015 mis à jour par: Merck Sharp & Dohme LLC
A Multiple Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-6325 in Hepatitis C Infected Male and Female Patients
This is a 2 part study of the safety, pharmacokinetics and pharmacodynamics of MK-6325 in HCV-infected participants.
Part I of the study will be for Genotype (GT) 1 HCV-infected participants who will be randomized to receive either MK-6325 or placebo.
If the drug is shown to be safe and efficacious in Part I, Part II will enroll GT 3 HCV-infected participants who will be randomized to receive either MK-6325 or placebo.
Aperçu de l'étude
Statut
Complété
Les conditions
Type d'étude
Interventionnel
Inscription (Réel)
36
Phase
- La phase 1
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion criteria:
- Body mass index (BMI) of 18 to ≤37 kg/m^2.
- Stable health
- No clinically significant abnormality on electrocardiogram (ECG)
- Clinical diagnosis of chronic HCV infection (G1 or G3) for at least 6 months and detectable HCV RNA in peripheral blood.
Exclusion criteria:
- Pregnancy or intention to become pregnant or father a child during the course of the study.
- History of stroke, chronic seizures, major neurological disorder, or uncontrolled clinically significant psychiatric disorder (for example, depression).
- Estimated creatinine clearance of ≤70 mL/min.
- History of clinically significant endocrine, gastrointestinal (except HCV infection), cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases whose current condition is considered clinically unstable.
- History of neoplastic disease other than adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix ≥10 years prior to the prestudy (screening) visit with no evidence of recurrence of likelihood of recurrence.
- Positive Hepatitis B surface antigen at the pre-study (screening) visit.
- History of documented HIV infection or positive HIV serology at the pre-study (screening) visit.
- Regular consumption of excessive amounts of alcohol, defined as greater than 2 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer [284 mL/10 ounces], wine [125 mL/4 ounces], or distilled spirits [25 mL/1 ounce]) per day.
- Excessive consumption, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) or coffee, tea, cola, or other caffeinated beverages per day.
- Major surgery, or donation or loss of 1 unit of blood (approximately 500 mL) or participated in another investigational study within 4 weeks prior to the prestudy (screening) visit.
- History of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food.
- Regular use of (including "recreational use") of any illicit drugs or has a history of drug (including alcohol) abuse within approximately 2 months. Exception: marijuana use is permitted at the discretion of the investigator and provided the participant can refrain from its use during the study.
- Evidence or history of chronic hepatitis not caused by HCV including but not limited to non-HCV viral hepatitis, non-alcoholic steatohepatitis (NASH), drug-induced hepatitis, autoimmune hepatitis. Note: Participants with history of acute non-HCV-related hepatitis, which resolved >6 months before study can be enrolled.
- Previous treatment with other HCV protease inhibitors ≤3 months prior to the first dose of study drug.
- Previous exposure to interferon-alpha and/or ribavirin within 3 month prior to the first dose of MK-6325 in the study.
- Clinical or laboratory evidence of advanced or decompensated liver disease; evidence of bridging fibrosis or higher grade fibrosis (Metavir score ≥3) from prior liver biopsy. Note: liver biopsy is not required for entry into the study.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: GT1-HCV 200 mg
|
Two 100 mg capsules, orally, once per day for 7 days
Two 100 mg capsules, orally, once per day for 7 days
Four 100 mg capsules, orally, once per day for 7 days
Four 100 mg capsules, orally, once per day for 7 days
Eight 100 mg capsules, orally, once per day for 7 days
Eight 100 mg capsules, orally, once per day for 7 days
|
|
Expérimental: GT1-HCV 400 mg
|
Two 100 mg capsules, orally, once per day for 7 days
Two 100 mg capsules, orally, once per day for 7 days
Four 100 mg capsules, orally, once per day for 7 days
Four 100 mg capsules, orally, once per day for 7 days
Eight 100 mg capsules, orally, once per day for 7 days
Eight 100 mg capsules, orally, once per day for 7 days
|
|
Expérimental: GTI-HCV 800 mg
|
Two 100 mg capsules, orally, once per day for 7 days
Two 100 mg capsules, orally, once per day for 7 days
Four 100 mg capsules, orally, once per day for 7 days
Four 100 mg capsules, orally, once per day for 7 days
Eight 100 mg capsules, orally, once per day for 7 days
Eight 100 mg capsules, orally, once per day for 7 days
|
|
Expérimental: GT3-HCV 200 mg
|
Two 100 mg capsules, orally, once per day for 7 days
Two 100 mg capsules, orally, once per day for 7 days
Four 100 mg capsules, orally, once per day for 7 days
Four 100 mg capsules, orally, once per day for 7 days
Eight 100 mg capsules, orally, once per day for 7 days
Eight 100 mg capsules, orally, once per day for 7 days
|
|
Expérimental: GT3-HCV 400 mg
|
Two 100 mg capsules, orally, once per day for 7 days
Two 100 mg capsules, orally, once per day for 7 days
Four 100 mg capsules, orally, once per day for 7 days
Four 100 mg capsules, orally, once per day for 7 days
Eight 100 mg capsules, orally, once per day for 7 days
Eight 100 mg capsules, orally, once per day for 7 days
|
|
Expérimental: GT3-HCV 800 mg
|
Two 100 mg capsules, orally, once per day for 7 days
Two 100 mg capsules, orally, once per day for 7 days
Four 100 mg capsules, orally, once per day for 7 days
Four 100 mg capsules, orally, once per day for 7 days
Eight 100 mg capsules, orally, once per day for 7 days
Eight 100 mg capsules, orally, once per day for 7 days
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Number of participants experiencing clinical and laboratory adverse events (AEs) (Parts I and II)
Délai: Up to 15 days after last dose of study drug
|
Up to 15 days after last dose of study drug
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Viral load reduction in GT1 HCV-infected participants (Part I)
Délai: 7 Days
|
7 Days
|
|
Viral load reduction in GT3 HCV-infected participants (Part II)
Délai: 7 Days
|
7 Days
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mai 2011
Achèvement primaire (Réel)
1 avril 2012
Achèvement de l'étude (Réel)
1 avril 2012
Dates d'inscription aux études
Première soumission
4 avril 2011
Première soumission répondant aux critères de contrôle qualité
5 avril 2011
Première publication (Estimation)
6 avril 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
5 février 2015
Dernière mise à jour soumise répondant aux critères de contrôle qualité
4 février 2015
Dernière vérification
1 février 2015
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 6325-003
- 2010-023687-40 (Numéro EudraCT)
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