NCT00998985

Brief Summary

This multiple dose study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of grazoprevir (MK-5172) in Genotype (GT) 1 and GT3 Hepatitis C virus (HCV)- infected participants. The primary hypothesis is that administration of grazoprevir for 7 days is sufficiently safe and well tolerated in HCV-infected males.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2010

Typical duration for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

February 23, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2012

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

March 2, 2016

Completed
Last Updated

July 17, 2018

Status Verified

June 1, 2018

Enrollment Period

2.7 years

First QC Date

October 20, 2009

Results QC Date

February 3, 2016

Last Update Submit

June 19, 2018

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Clinical and Laboratory Adverse Events (AEs)

    An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, is also an AE.

    All AEs: 15 Days after last dose; Serious AEs (SAEs) up to 2 months after last dose (Up to 67 days)

Secondary Outcomes (4)

  • Area Under the Curve for 0 to 24 Hours Post-dose (AUC[0-24hr]) of Grazoprevir on Day 7

    Day 7 at the following time points: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose

  • 24 Hour Plasma Concentration (C[24hr]) of Grazoprevir on Day 7

    Day 7 at 24 hours post-dose

  • Maximum log10 HCV RNA Reduction From Baseline Following Administration of Grazoprevir in Participants With GT1 HCV or Pooled GT1 and GT3 HCV Participants Treated With Placebo

    Baseline and up to approximately 2 months

  • Maximum log10 HCV RNA Reduction From Baseline Following Administration of Grazoprevir in Participants With GT3 HCV or Pooled GT1 and GT3 HCV Participants Treated With Placebo

    Baseline and up to approximately 2 months

Study Arms (14)

400 mg Grazoprevir - GT1

EXPERIMENTAL

GT1 HCV-infected Participants: 400 mg Grazoprevir or Placebo

Drug: GrazoprevirDrug: Placebo

600 mg Grazoprevir - GT1

EXPERIMENTAL

GT1 HCV-infected Participants: 600 mg Grazoprevir or Placebo

Drug: GrazoprevirDrug: Placebo

800 mg Grazoprevir - GT1

EXPERIMENTAL

GT1 HCV-infected Participants: 800 mg Grazoprevir or Placebo

Drug: GrazoprevirDrug: Placebo

400 mg Grazoprevir - GT3

EXPERIMENTAL

GT3 HCV-infected Participants: 400 mg Grazoprevir or Placebo

Drug: GrazoprevirDrug: Placebo

600 mg Grazoprevir - GT3

EXPERIMENTAL

GT3 HCV-infected Participants: 600 mg Grazoprevir or Placebo

Drug: GrazoprevirDrug: Placebo

800 mg Grazoprevir - GT3

EXPERIMENTAL

GT3 HCV-infected Participants: 800 mg Grazoprevir or Placebo

Drug: GrazoprevirDrug: Placebo

200 mg Grazoprevir - GT1

EXPERIMENTAL

GT1 HCV-infected Participants: 200 mg Grazoprevir or Placebo

Drug: GrazoprevirDrug: Placebo

100 mg Grazoprevir - GT1

EXPERIMENTAL

GT1 HCV-infected Participants: 100 mg Grazoprevir or Placebo

Drug: GrazoprevirDrug: Placebo

50 mg Grazoprevir - GT1

EXPERIMENTAL

GT1 HCV-infected Participants: 50 mg Grazoprevir or Placebo

Drug: GrazoprevirDrug: Placebo

200 mg Grazoprevir - GT3

EXPERIMENTAL

GT3 HCV-infected Participants: 200 mg Grazoprevir or Placebo

Drug: GrazoprevirDrug: Placebo

100 mg Grazoprevir - GT3

EXPERIMENTAL

GT3 HCV-infected Participants: 100 mg Grazoprevir or Placebo

Drug: GrazoprevirDrug: Placebo

50 mg Grazoprevir - GT3

EXPERIMENTAL

GT3 HCV-infected Participants: 50 mg Grazoprevir or Placebo

Drug: GrazoprevirDrug: Placebo

30 mg Grazoprevir - GT1

EXPERIMENTAL

GT1 HCV-infected Participants: 30 mg Grazoprevir or Placebo

Drug: GrazoprevirDrug: Placebo

10 mg Grazoprevir - GT1

EXPERIMENTAL

GT1 HCV-infected Participants: 10 mg Grazoprevir or Placebo

Drug: GrazoprevirDrug: Placebo

Interventions

GrazoprevirDRUG

10, 30, 50, 100, 200, 400, 600 or 800 mg Grazoprevir tablets, orally, once a day for 7 days

10 mg Grazoprevir - GT1100 mg Grazoprevir - GT1100 mg Grazoprevir - GT3200 mg Grazoprevir - GT1200 mg Grazoprevir - GT330 mg Grazoprevir - GT1400 mg Grazoprevir - GT1400 mg Grazoprevir - GT350 mg Grazoprevir - GT150 mg Grazoprevir - GT3600 mg Grazoprevir - GT1600 mg Grazoprevir - GT3800 mg Grazoprevir - GT1800 mg Grazoprevir - GT3
PlaceboDRUG

Placebo tablet, orally, once a day for 7 days

10 mg Grazoprevir - GT1100 mg Grazoprevir - GT1100 mg Grazoprevir - GT3200 mg Grazoprevir - GT1200 mg Grazoprevir - GT330 mg Grazoprevir - GT1400 mg Grazoprevir - GT1400 mg Grazoprevir - GT350 mg Grazoprevir - GT150 mg Grazoprevir - GT3600 mg Grazoprevir - GT1600 mg Grazoprevir - GT3800 mg Grazoprevir - GT1800 mg Grazoprevir - GT3

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Baseline health is stable.
  • Has a clinical diagnosis of chronic HCV infection.

You may not qualify if:

  • Has a history of stroke or chronic seizures.
  • Has a history of cancer.
  • Has a history of human immunodeficiency virus (HIV) infection.
  • Has had major surgery, donated blood or participated in another investigational study within the past 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Yeh WW, Fraser IP, Jumes P, Petry A, Lepeleire I, Robberechts M, Reitmann C, Van Dyck K, Huang X, Guo Z, Panebianco D, Nachbar RB, O'Mara E, Wagner JA, Butterton JR, Dutko FJ, Moiseev V, Kobalava Z, Huser A, Visan S, Schwabe C, Gane E, Popa S, Ghicavii N, Uhle M, Wagner F. Antiviral Activity, Safety, and Tolerability of Multiple Ascending Doses of Elbasvir or Grazoprevir in Participants Infected With Hepatitis C Virus Genotype-1 or -3. Clin Ther. 2018 May;40(5):704-718.e6. doi: 10.1016/j.clinthera.2018.03.002. Epub 2018 Apr 25.

    PMID: 29703432RESULT

MeSH Terms

Conditions

Hepatitis C

Interventions

grazoprevir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp.
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

Study Officials

  • Medical Director

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2009

First Posted

October 21, 2009

Study Start

February 23, 2010

Primary Completion

November 8, 2012

Study Completion

November 8, 2012

Last Updated

July 17, 2018

Results First Posted

March 2, 2016

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will share

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf

More information

Available IPD Datasets

CSR Synopsis Access