NCT01508156

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2012

Shorter than P25 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

Study Start

First participant enrolled

January 1, 2012

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

April 27, 2015

Status Verified

April 1, 2015

Enrollment Period

6 months

First QC Date

January 9, 2012

Last Update Submit

April 24, 2015

Conditions

Hepatitis C, Chronic

Keywords

Hepatitis CHCVtreatment-naive

Outcome Measures

Primary Outcomes (18)

  • Percentage of participants experiencing an adverse event (AE)

    Up to 14 days

  • Percentage of participants experiencing serious AEs (SAEs)

    Up to 14 days

  • Change in HCV ribonucleic acid (RNA)

    Baseline and Day 10

  • Maximum plasma drug concentration (Cmax)

    Pre-dose Day 1 to Day 13

  • Time to maximum plasma drug concentration (Tmax)

    Pre-dose Day 1 to Day 13

  • Area under the plasma drug concentration-time curve (AUC) from time zero to time of last measurable concentration (AUC0-t)

    Pre-dose Day 1 to Day 13

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

    Pre-dose Day 1 to Day 1

  • AUC from time zero to time infinity (AUC0-~)

    Pre-dose Day 1 to Day 13

  • Pre-dose trough plasma drug concentration (Ctrough)

    Pre-dose Day 1

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

    Pre-dose Day 1 to Day 13

  • Apparent oral total plasma drug clearance (CL/F) as Dose/AUC0-~ (single dose) or Dose/AUC0-t (multiple doses)

    Pre-dose Day 1 to Day 13

  • Apparent oral total volume of distribution (Vz/F)

    Pre-dose Day 1 to Day 13

  • Amount excreted in urine in each collection interval (Au)

    Pre-dose Day 1 to Day 14

  • Cumulative urine excretion (Au0-t)

    Pre-dose Day 1 to Day 14

  • Percentage of dose excreted in urine (% Dose excr)

    Pre-dose Day 1 to Day 14

  • Renal clearance (CLr)

    Pre-dose Day 1 to Day 14

  • Percentage of participants experiencing dose-limiting toxicity

    Up to 8 days

  • Percentage of participants experiencing graded laboratory abnormalities

    Up to 14 days

Study Arms (2)

Group A: Healthy Participants

EXPERIMENTAL

Healthy participants take IDX719 (5 mg - 100 mg) or matching placebo by mouth as either 1 single dose or as 7 daily doses.

Drug: IDX719Drug: Placebo

Group B: HCV Participants

EXPERIMENTAL

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: IDX719Drug: Placebo

Interventions

IDX719DRUG

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

Group A: Healthy ParticipantsGroup B: HCV Participants
PlaceboDRUG

Placebo liquid suspension matching IDX719 taken by mouth.

Group A: Healthy ParticipantsGroup B: HCV Participants

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Vince B, Hill JM, Lawitz EJ, O'Riordan W, Webster LR, Gruener DM, Mofsen RS, Murillo A, Donovan E, Chen J, McCarville JF, Sullivan-Bolyai JZ, Mayers D, Zhou XJ. A randomized, double-blind, multiple-dose study of the pan-genotypic NS5A inhibitor samatasvir in patients infected with hepatitis C virus genotype 1, 2, 3 or 4. J Hepatol. 2014 May;60(5):920-7. doi: 10.1016/j.jhep.2014.01.003. Epub 2014 Jan 14.

    PMID: 24434503RESULT

MeSH Terms

Conditions

Hepatitis C, ChronicHepatitis C

Interventions

samatasvir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Medical Director

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

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

January 9, 2012

First Posted

January 11, 2012

Study Start

January 1, 2012

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

April 27, 2015

Record last verified: 2015-04