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

February 10, 2012
August 15, 2014
February 2012
May 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01532973 on ClinicalTrials.gov Archive Site
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Safety, Pharmacokinetics and Pharmacodynamics of MK-8742 in Hepatitis C Infected Males (MK-8742-002 AM1)
A Multiple Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-8742 in Hepatitis C Infected Males

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hepatitis, Viral, Human
  • Drug: MK-8742
    MK-8742 was administered orally by tablet(s)
  • Drug: Placebo
    Dose-matched placebo tablets were administered orally.
  • 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.
    Intervention: Drug: MK-8742
  • 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.
    Intervention: Drug: MK-8742
  • 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.
    Intervention: Drug: MK-8742
  • 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.
    Intervention: Drug: MK-8742
  • 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.
    Intervention: Drug: MK-8742
  • 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.
    Intervention: Drug: MK-8742
  • 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.
    Intervention: Drug: MK-8742
  • 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.
    Intervention: Drug: MK-8742
  • 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.
    Intervention: Drug: MK-8742
  • 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.
    Intervention: Drug: MK-8742
  • Placebo Comparator: Placebo
    Participants receive dose-matched placebo to MK-8742 for 5 consecutive days.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Male
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01532973
8742-002, 2011-005190-23
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP