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Completed

NCT Number: NCT01508156

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

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.

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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

IDX719

Drug

IDX719 liquid suspension (1 - 100 mg) taken by mouth.

Placebo

Drug

Placebo liquid suspension matching IDX719 taken by mouth.

Primary outcomes

  1. Percentage of participants experiencing an adverse event (AE)

    Time frame: Up to 14 days

  2. Percentage of participants experiencing serious AEs (SAEs)

    Time frame: Up to 14 days

  3. Change in HCV ribonucleic acid (RNA)

    Time frame: Baseline and Day 10

  4. Maximum plasma drug concentration (Cmax)

    Time frame: Pre-dose Day 1 to Day 13

  5. Time to maximum plasma drug concentration (Tmax)

    Time frame: Pre-dose Day 1 to Day 13

  6. 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

  7. AUC from time zero to time 24 hours (AUC0-24h)

    Time frame: Pre-dose Day 1 to Day 1

  8. AUC from time zero to time infinity (AUC0-~)

    Time frame: Pre-dose Day 1 to Day 13

  9. Pre-dose trough plasma drug concentration (Ctrough)

    Time frame: Pre-dose Day 1

  10. Observed terminal plasma drug concentration half-life (t1/2)

    Time frame: Pre-dose Day 1 to Day 13

  11. 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

  12. Apparent oral total volume of distribution (Vz/F)

    Time frame: Pre-dose Day 1 to Day 13

  13. Amount excreted in urine in each collection interval (Au)

    Time frame: Pre-dose Day 1 to Day 14

  14. Cumulative urine excretion (Au0-t)

    Time frame: Pre-dose Day 1 to Day 14

  15. Percentage of dose excreted in urine (% Dose excr)

    Time frame: Pre-dose Day 1 to Day 14

  16. Renal clearance (CLr)

    Time frame: Pre-dose Day 1 to Day 14

  17. Percentage of participants experiencing dose-limiting toxicity

    Time frame: Up to 8 days

  18. Percentage of participants experiencing graded laboratory abnormalities

    Time frame: Up to 14 days

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase I/IIa Study Assessing Single and Multiple Doses of HCV NS5A Inhibitor IDX719 in Healthy and HCV-Infected Subjects

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 11, 2012
Registry last updated
Apr 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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