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Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK3281 in Healthy and Hepatitis C Infected Male Patients (MK-3281-002)(TERMINATED)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00635804
First received: February 28, 2008
Last updated: November 4, 2014
Last verified: November 2014
  Purpose

This study will examine the safety, tolerability and plasma pharmacokinetics of multiple doses of MK3281 in healthy male subjects in Part I, and in HCV-infected male patients in Part II. The clinical efficacy of MK3281, as measured by viral load reduction, will also be assessed in Part II. The results of this study will guide dose selection for future studies in both healthy subjects and HCV-infected patients.


Condition Intervention Phase
Hepatitis C
Drug: MK3281
Drug: Comparator: placebo (unspecified)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A 2-Part, Randomized, Double-Blind, Placebo-Controlled, Multiple-Rising Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK3281 in Healthy Male Subjects and Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK3281 in Hepatitis C Infected Male Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To evaluate the safety, tolerability, and Pharmacokinetics of MK3281 in both healthy and HCV-infected males. [ Time Frame: administered for 10 consecutive days to healthy adult male subjects and 7 consecutive days in HCV-infected male patients ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To identify a generally safe and well-tolerated dose in HCV-infected patients that mediates a viral load reduction. [ Time Frame: After multiple dose oral administration of MK3281 throughout the duration of the study. ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: February 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Panel A: study medication (100 mg) + matching Pbo
Drug: MK3281
Part I, 4 serial panels (Panels A, B, C, and D) will be administered oral doses (ranging from 100 mg to 800 mg) of MK3281 twice daily for 10 consecutive days. In Part II, another panel, Panel E, consisting of HCV-infected patients be administered 800 mg oral doses of MK3281, or matching placebo, twice daily for 7 consecutive days.
Drug: Comparator: placebo (unspecified)
Part I, 4 serial panels (Panels A, B, C, and D) will be administered oral doses of matching placebo, twice daily for 10 consecutive days. In Part II, another panel, Panel E, consisting of HCV-infected patients be administered matching placebo, twice daily for 7 consecutive days.
Experimental: B
Panel B: study medication (200 mg) + matching Pbo
Drug: MK3281
Part I, 4 serial panels (Panels A, B, C, and D) will be administered oral doses (ranging from 100 mg to 800 mg) of MK3281 twice daily for 10 consecutive days. In Part II, another panel, Panel E, consisting of HCV-infected patients be administered 800 mg oral doses of MK3281, or matching placebo, twice daily for 7 consecutive days.
Drug: Comparator: placebo (unspecified)
Part I, 4 serial panels (Panels A, B, C, and D) will be administered oral doses of matching placebo, twice daily for 10 consecutive days. In Part II, another panel, Panel E, consisting of HCV-infected patients be administered matching placebo, twice daily for 7 consecutive days.
Experimental: C
Panel C: study medication (400 mg) + matching Pbo
Drug: MK3281
Part I, 4 serial panels (Panels A, B, C, and D) will be administered oral doses (ranging from 100 mg to 800 mg) of MK3281 twice daily for 10 consecutive days. In Part II, another panel, Panel E, consisting of HCV-infected patients be administered 800 mg oral doses of MK3281, or matching placebo, twice daily for 7 consecutive days.
Drug: Comparator: placebo (unspecified)
Part I, 4 serial panels (Panels A, B, C, and D) will be administered oral doses of matching placebo, twice daily for 10 consecutive days. In Part II, another panel, Panel E, consisting of HCV-infected patients be administered matching placebo, twice daily for 7 consecutive days.
Experimental: D
Panel D: study medication (800 mg) + matching Pbo
Drug: MK3281
Part I, 4 serial panels (Panels A, B, C, and D) will be administered oral doses (ranging from 100 mg to 800 mg) of MK3281 twice daily for 10 consecutive days. In Part II, another panel, Panel E, consisting of HCV-infected patients be administered 800 mg oral doses of MK3281, or matching placebo, twice daily for 7 consecutive days.
Drug: Comparator: placebo (unspecified)
Part I, 4 serial panels (Panels A, B, C, and D) will be administered oral doses of matching placebo, twice daily for 10 consecutive days. In Part II, another panel, Panel E, consisting of HCV-infected patients be administered matching placebo, twice daily for 7 consecutive days.
Experimental: E
Panel E: study medication (800 mg) + matching Pbo
Drug: MK3281
Part I, 4 serial panels (Panels A, B, C, and D) will be administered oral doses (ranging from 100 mg to 800 mg) of MK3281 twice daily for 10 consecutive days. In Part II, another panel, Panel E, consisting of HCV-infected patients be administered 800 mg oral doses of MK3281, or matching placebo, twice daily for 7 consecutive days.
Drug: Comparator: placebo (unspecified)
Part I, 4 serial panels (Panels A, B, C, and D) will be administered oral doses of matching placebo, twice daily for 10 consecutive days. In Part II, another panel, Panel E, consisting of HCV-infected patients be administered matching placebo, twice daily for 7 consecutive days.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is judged to be in good/stable health based on medical history, physical examination, vital signs, and laboratory safety tests performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug
  • Subject has no clinically significant abnormality on electrocardiogram (ECG) performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug
  • Subjects with female partner(s) of childbearing potential must agree to use a medically acceptable method of contraception during the study and for 90 days after the last dose of study drug
  • Patient has a clinical diagnosis of chronic HCV infection.

Exclusion Criteria:

  • Subject has a history of stroke, chronic seizures, or major neurological disorder
  • Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases
  • Subject has a history of neoplastic disease (including leukemia, lymphoma, malignant melanoma), or myeloproliferative disease, regardless of the time since treatment
  • Subject has positive Hepatitis B surface antigen (or other evidence of active Hepatitis B infection) at the prescreening (study) visit
  • For Healthy Panel, subject has evidence of chronic Hepatitis C virus infection at the prescreening (study) visit
  • Subject has a history of documented HIVinfection
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00635804

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00635804     History of Changes
Other Study ID Numbers: 3281-002, 2008_507
Study First Received: February 28, 2008
Last Updated: November 4, 2014
Health Authority: Scotland: Scottish Executive Health Department

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

ClinicalTrials.gov processed this record on November 25, 2014