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Assessing Single and Multiple Doses of HCV NS5A Inhibitor IDX719 in Healthy and HCV-Infected Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01508156
First received: January 9, 2012
Last updated: July 12, 2012
Last verified: July 2012
  Purpose

The purpose of the study is to test different doses of IDX719 to find the best dose for future studies. The study will also assess the effect of food on IDX719 pharmacokinetics.


Condition Intervention Phase
Hepatitis C, Chronic
Drug: IDX719 or matching placebo (oral suspension)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I/IIa Study Assessing Single and Multiple Doses of HCV NS5A Inhibitor IDX719 in Healthy and HCV-Infected Subjects

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Safety and Tolerability [ Time Frame: Up to 13 days ] [ Designated as safety issue: Yes ]
    Number of subjects with adverse events as a measure of safety and tolerability

  • Antiviral Activity [ Time Frame: Up to 5 days ] [ Designated as safety issue: Yes ]
    • change in plasma HCV RNA
    • emergence of resistance mutations

  • Pharmacokinetic [ Time Frame: Up to 13 days ] [ Designated as safety issue: Yes ]
    concentration of IDX719 in plasma and urine


Enrollment: 130
Study Start Date: January 2012
Study Completion Date: July 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Healthy volunteers, 5 mg - 100 mg of IDX719 or matching placebo
Drug: IDX719 or matching placebo (oral suspension)
5 mg - 100 mg of IDX719 or matching placebo as a single dose, two doses (food effect) or three doses daily.
Experimental: Group B
HCV subjects, 1 mg - 100 mg of IDX719 single dose or matching placebo
Drug: IDX719 or matching placebo (oral suspension)
1 mg - 100 mg, as a single dose

  Eligibility

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

Inclusion Criteria:

All Subjects

  • Subjects are in good general health.
  • Subjects have provided written informed consent form --Subjects must agree to use double-barrier method of birth control for at least 90 days after the last dose of study drugs.

HCV Subjects

  • Subjects must have documented genotype 1, chronic hepatitis C infection.

Exclusion Criteria:

All Subjects

  • Pregnant or breastfeeding.

HCV Subjects

  • Prior HCV treatment.
  • Co-infected with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV).
  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: NCT01508156

Locations
United States, Kansas
Overland Park, Kansas, United States
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01508156     History of Changes
Other Study ID Numbers: IDX-06A-001
Study First Received: January 9, 2012
Last Updated: July 12, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Hepatitis C
HCV
treatment-naive

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

ClinicalTrials.gov processed this record on November 20, 2014