Safety, Pharmacokinetics and Pharmacodynamics of MK-8742 in Hepatitis C Infected Males (MK-8742-002 AM1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01532973
First received: February 10, 2012
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to assess the safety, pharmacokinetics (PK) and pharmacodynamics of MK-8742 in Hepatitis C Virus (HCV)-infected participants. There will be 3 parts to this study; Part I will enroll only genotype 1 HCV-infected participants, Part II will enroll genotype 3 (GT3) HCV-infected participants, and Part III will enroll only GT1a HCV-infected participants. All parts may run concurrently, or Parts II and III may be staggered.


Condition Intervention Phase
Hepatitis, Viral, Human
Drug: MK-8742
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multiple Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-8742 in Hepatitis C Infected Males

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change From Baseline in Plasma HCV RNA at Day 5 [ Time Frame: From Baseline to 24-hour post-dose on Day 5 ] [ Designated as safety issue: No ]
  • Mean Maximum Change in HCV Viral Load [ Time Frame: From Baseline to 24-hour post-dose on Day 5 ] [ Designated as safety issue: No ]
  • Number of participants experiencing an adverse event [ Time Frame: Predose up to 56 days ] [ Designated as safety issue: Yes ]
  • Number of participants discontinuing study treatment due to an adverse event [ Time Frame: Day 1 to Day 5 ] [ Designated as safety issue: Yes ]

Enrollment: 48
Study Start Date: February 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GT1 HCV Low Dose (Panel A)
Participants with GT1 Hepatitis receive low dose MK-8742 for 5 consecutive days during Part I of the study.
Drug: MK-8742
MK-8742 was administered orally by tablet(s)
Experimental: GTI HCV Mid-Low Dose (Panel B)
Participants with GT1 Hepatitis receive mid-low dose MK-8742 for 5 consecutive days during Part I of the study.
Drug: MK-8742
MK-8742 was administered orally by tablet(s)
Experimental: GT1 HCV Mid-High Dose (Panel C)
Participants with GT1 Hepatitis receive mid-high dose MK-8742 for 5 consecutive days during Part I of the study.
Drug: MK-8742
MK-8742 was administered orally by tablet(s)
Experimental: GT1 HCV High Dose (Panel D)
Participants with GT1 Hepatitis receive high dose MK-8742 for 5 consecutive days during Part I of the study.
Drug: MK-8742
MK-8742 was administered orally by tablet(s)
Experimental: GT3 HCV Low Dose (Panel E)
Participants with Genotype 3 (GT3) Hepatitis receive low dose MK-8742 for 5 consecutive days during Part II of the study.
Drug: MK-8742
MK-8742 was administered orally by tablet(s)
Experimental: GT3 HCV Mid-Low dose (Panel F)
Participants with GT3 Hepatitis receive mid-low dose MK-8742 for 5 consecutive days during Part II of the study.
Drug: MK-8742
MK-8742 was administered orally by tablet(s)
Experimental: GT3 HCV Mid-High Dose (Panel G)
Participants with GT3 Hepatitis receive mid-high dose of MK-8742 for 5 consecutive days during Part II of the study.
Drug: MK-8742
MK-8742 was administered orally by tablet(s)
Experimental: GT3 HCV High Dose (Panel H)
Participants with GT3 Hepatitis receive high dose MK-8742 for 5 consecutive days during Part II of the study.
Drug: MK-8742
MK-8742 was administered orally by tablet(s)
Experimental: GT1a Low Dose (Panel I)
Participants with GT1a only Hepatitis receive low dose MK-8742 for 5 consecutive days during Part III of the study.
Drug: MK-8742
MK-8742 was administered orally by tablet(s)
Experimental: GT1a Mid-Low Dose (Panel J)
Participants with GT1a only Hepatitis receive mid-low dose MK-8742 for 5 consecutive days during Part III of the study.
Drug: MK-8742
MK-8742 was administered orally by tablet(s)
Placebo Comparator: Placebo
Participants receive dose-matched placebo to MK-8742 for 5 consecutive days.
Drug: Placebo
Dose-matched placebo tablets were administered orally.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body Mass Index (BMI) of 18 to ≤ 37 kg/m^2
  • Clinical diagnosis of chronic HCV infection defined by positive serology for HCV for at least 6 months and detectable HCV RNA in peripheral blood ≥105 IU/mL at screening
  • Participant must be infected with HCV GT1a, GT1b, or GT 3

Exclusion Criteria:

  • Co-infection with GT1 and GT3
  • Estimated creatinine clearance of ≤70 mL/min based on the Cockcroft-Gault equation
  • History of stroke, chronic seizures, or major neurological disorder
  • History of clinically significant endocrine, gastrointestinal (excepting HCV infection), cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases
  • History of neoplastic disease
  • Positive Hepatitis B surface antigen at the pre-study (screening) visit
  • Has had major surgery, donated or lost 1 unit of blood (approximately 500 mL) or participated in another investigational study within 4 weeks prior to the prestudy (screening) visit.
  • Previous treatments (s) with nonstructural protein 5A (NS5A) inhibitors
  • <4 weeks since administration of any experimental protease inhibitor
  • Previous exposure to interferon-alpha and/or ribavirin within 3 month prior to the first dose of MK-8742 in the study
  • Clinical or laboratory evidence of advanced or decompensated liver disease
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01532973     History of Changes
Other Study ID Numbers: 8742-002, 2011-005190-23
Study First Received: February 10, 2012
Last Updated: May 28, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on April 17, 2014