Study of Hepatitis C Virus (HCV) Nonstructural Protein 5a (NS5A) Inhibitor IDX719 in Healthy and HCV-Infected Participants (MK-1894-001)

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: April 24, 2015
Last verified: April 2015
  Purpose

The purpose of the study is to test the safety and tolerability of different doses of IDX719 to find the best dose for future studies. The study will also assess the pharmacokinetics of IDX719. No formal hypotheses will be tested.


Condition Intervention Phase
Hepatitis C, Chronic
Drug: IDX719
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
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:
  • Percentage of participants experiencing an adverse event (AE) [ Time Frame: Up to 14 days ] [ Designated as safety issue: Yes ]
  • Percentage of participants experiencing serious AEs (SAEs) [ Time Frame: Up to 14 days ] [ Designated as safety issue: Yes ]
  • Change in HCV ribonucleic acid (RNA) [ Time Frame: Baseline and Day 10 ] [ Designated as safety issue: No ]
  • Maximum plasma drug concentration (Cmax) [ Time Frame: Pre-dose Day 1 to Day 13 ] [ Designated as safety issue: No ]
  • Time to maximum plasma drug concentration (Tmax) [ Time Frame: Pre-dose Day 1 to Day 13 ] [ Designated as safety issue: No ]
  • Area under the plasma drug concentration-time curve (AUC) from time zero to time of last measurable concentration (AUC0-t) [ Time Frame: Pre-dose Day 1 to Day 13 ] [ Designated as safety issue: No ]
  • AUC from time zero to time 24 hours (AUC0-24h) [ Time Frame: Pre-dose Day 1 to Day 1 ] [ Designated as safety issue: No ]
  • AUC from time zero to time infinity (AUC0-~) [ Time Frame: Pre-dose Day 1 to Day 13 ] [ Designated as safety issue: No ]
  • Pre-dose trough plasma drug concentration (Ctrough) [ Time Frame: Pre-dose Day 1 ] [ Designated as safety issue: No ]
  • Observed terminal plasma drug concentration half-life (t1/2) [ Time Frame: Pre-dose Day 1 to Day 13 ] [ Designated as safety issue: No ]
  • Apparent oral total plasma drug clearance (CL/F) as Dose/AUC0-~ (single dose) or Dose/AUC0-t (multiple doses) [ Time Frame: Pre-dose Day 1 to Day 13 ] [ Designated as safety issue: No ]
  • Apparent oral total volume of distribution (Vz/F) [ Time Frame: Pre-dose Day 1 to Day 13 ] [ Designated as safety issue: No ]
  • Amount excreted in urine in each collection interval (Au) [ Time Frame: Pre-dose Day 1 to Day 14 ] [ Designated as safety issue: No ]
  • Cumulative urine excretion (Au0-t) [ Time Frame: Pre-dose Day 1 to Day 14 ] [ Designated as safety issue: No ]
  • Percentage of dose excreted in urine (% Dose excr) [ Time Frame: Pre-dose Day 1 to Day 14 ] [ Designated as safety issue: No ]
  • Renal clearance (CLr) [ Time Frame: Pre-dose Day 1 to Day 14 ] [ Designated as safety issue: No ]
  • Percentage of participants experiencing dose-limiting toxicity [ Time Frame: Up to 8 days ] [ Designated as safety issue: Yes ]
  • Percentage of participants experiencing graded laboratory abnormalities [ Time Frame: Up to 14 days ] [ Designated as safety issue: Yes ]

Enrollment: 130
Study Start Date: January 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A: Healthy Participants
Healthy participants take IDX719 (5 mg - 100 mg) or matching placebo by mouth as either 1 single dose or as 7 daily doses.
Drug: IDX719
IDX719 liquid suspension (1 - 100 mg) taken by mouth.
Drug: Placebo
Placebo liquid suspension matching IDX719 taken by mouth.
Experimental: Group B: HCV Participants
Treatment-naive participants infected with HCV genotype (GT) 1, GT2, or GT3 take IDX719 (1 mg - 100 mg) or matching placebo as either 1 single dose or as 7 daily doses.
Drug: IDX719
IDX719 liquid suspension (1 - 100 mg) taken by mouth.
Drug: Placebo
Placebo liquid suspension matching IDX719 taken by mouth.

  Eligibility

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

Inclusion Criteria:

  • All Participants
  • Is in good general health.
  • Agrees to use double-barrier method of birth control for at least 90 days after the last dose of study drugs.
  • HCV Participants
  • Has documented GT1, GT2, or GT3 chronic HCV infection.

Exclusion Criteria:

  • All Participants
  • Is pregnant or breastfeeding.

HCV Participants

  • Has received prior HCV treatment.
  • Is 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

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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01508156     History of Changes
Other Study ID Numbers: 1894-001, IDX-06A-001
Study First Received: January 9, 2012
Last Updated: April 24, 2015
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 A
Hepatitis C
Hepatitis C, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Chronic
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on May 21, 2015