Trial record 18 of 2297 for:    "Hepatitis, Viral, Human"

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: August 15, 2014
Last verified: August 2014
  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
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: NCT01532973     History of Changes
Other Study ID Numbers: 8742-002, 2011-005190-23
Study First Received: February 10, 2012
Last Updated: August 15, 2014
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 August 19, 2014