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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014