Safety, Pharmacokinetics, and Pharmacodynamics of MK-6325 in Hepatitis C Virus (HCV) Infections (MK-6325-003)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01329913
First received: April 4, 2011
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Hepatitis C
Drug: MK-6325
Drug: Placebo to MK-6325
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multiple Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-6325 in Hepatitis C Infected Male and Female Patients

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of participants experiencing clinical and laboratory adverse events (AEs) (Parts I and II) [ Time Frame: Up to 15 days after last dose of study drug ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Viral load reduction in GT1 HCV-infected participants (Part I) [ Time Frame: 7 Days ] [ Designated as safety issue: No ]
  • Viral load reduction in GT3 HCV-infected participants (Part II) [ Time Frame: 7 Days ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: May 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GT1-HCV 200 mg Drug: MK-6325
Two 100 mg capsules, orally, once per day for 7 days
Drug: Placebo to MK-6325
Two 100 mg capsules, orally, once per day for 7 days
Experimental: GT1-HCV 400 mg Drug: MK-6325
Four 100 mg capsules, orally, once per day for 7 days
Drug: Placebo to MK-6325
Four 100 mg capsules, orally, once per day for 7 days
Experimental: GTI-HCV 800 mg Drug: MK-6325
Eight 100 mg capsules, orally, once per day for 7 days
Drug: Placebo to MK-6325
Eight 100 mg capsules, orally, once per day for 7 days
Experimental: GT3-HCV 200 mg Drug: MK-6325
Two 100 mg capsules, orally, once per day for 7 days
Drug: Placebo to MK-6325
Two 100 mg capsules, orally, once per day for 7 days
Experimental: GT3-HCV 400 mg Drug: MK-6325
Four 100 mg capsules, orally, once per day for 7 days
Drug: Placebo to MK-6325
Four 100 mg capsules, orally, once per day for 7 days
Experimental: GT3-HCV 800 mg Drug: MK-6325
Eight 100 mg capsules, orally, once per day for 7 days
Drug: Placebo to MK-6325
Eight 100 mg capsules, orally, once per day for 7 days

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01329913     History of Changes
Other Study ID Numbers: 6325-003, 2010-023687-40
Study First Received: April 4, 2011
Last Updated: February 26, 2014
Health Authority: European Union: European Medicines Agency

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on April 17, 2014