NCT01157104

Brief Summary

This study is designed to evaluate the potential for a pharmacokinetic (PK) drug-drug interaction between IDX320 and IDX184 and to assess the safety and tolerability when the two drugs are administered in combination in healthy participants.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2010

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

June 1, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 2, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 5, 2010

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

January 22, 2016

Status Verified

January 1, 2016

Enrollment Period

1 month

First QC Date

July 2, 2010

Last Update Submit

January 20, 2016

Conditions

Chronic Hepatitis C

Keywords

HCVHepatitis C

Outcome Measures

Primary Outcomes (9)

  • Area under the curve at steady state (AUCss) of plasma IDX320

    Days 1-7 pre-dose; Day 7: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20 hrs postdose; Days 8-14 pre-dose; Day 14: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hrs postdose

  • AUCss of plasma IDX184

    Days 1-7 pre-dose; Day 7: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20 hrs postdose; Days 8-14 pre-dose; Day 14: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hrs postdose

  • AUCss of plasma 2'-methylguanosine (2'-MeG)

    Days 1-7 pre-dose; Day 7: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20 hrs postdose; Days 8-14 pre-dose; Day 14: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hrs postdose

  • Maximum observed concentration (Cmax) of plasma IDX320

    Days 1-7 pre-dose; Day 7: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20 hrs postdose; Days 8-14 pre-dose; Day 14: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hrs postdose

  • Cmax of plasma IDX184

    Days 1-7 pre-dose; Day 7: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20 hrs postdose; Days 8-14 pre-dose; Day 14: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hrs postdose

  • Cmax of plasma 2'-MeG

    Days 1-7 pre-dose; Day 7: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20 hrs postdose; Days 8-14 pre-dose; Day 14: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hrs postdose

  • Trough concentration (Ctrough) of plasma IDX320

    Days 1-7 pre-dose; Day 7: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20 hrs postdose; Days 8-14 pre-dose; Day 14: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hrs postdose

  • Ctrough of plasma IDX184

    Days 1-7 pre-dose; Day 7: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20 hrs postdose; Days 8-14 pre-dose; Day 14: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hrs postdose

  • Ctrough of plasma 2"-MeG

    Days 1-7 pre-dose; Day 7: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20 hrs postdose; Days 8-14 pre-dose; Day 14: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hrs postdose

Secondary Outcomes (2)

  • Number of participants with an adverse event (AE)

    Up to Day 19

  • Number of participants who discontinued treatment due to an AE

    Up to Day 14

Study Arms (3)

IDX320 + PBO → IDX320 + IDX184

EXPERIMENTAL

400 mg IDX320 and IDX184 matching placebo (PBO) once daily for 7 days; followed by 400 mg IDX320 and 100 mg IDX184 once daily for 7 days

Drug: IDX320Drug: IDX184Drug: IDX184 placebo

IDX184 + PBO → IDX184 + IDX320

EXPERIMENTAL

100 mg IDX184 and IDX320 matching PBO for 7 days; followed by 100 mg IDX184 and 400 mg IDX320 for 7 days

Drug: IDX320Drug: IDX184Drug: IDX320 placebo

IDX320 PBO + IDX184 PBO

PLACEBO COMPARATOR

IDX320 matching PBO + IDX184 matching PBO for 14 days

Drug: IDX184 placeboDrug: IDX320 placebo

Interventions

IDX320DRUG

IDX320 400 mg in tablets (8x50 mg) administered orally once daily

IDX184 + PBO → IDX184 + IDX320IDX320 + PBO → IDX320 + IDX184
IDX184DRUG

IDX184 100 mg in capsules (2x50 mg) administered orally once daily

IDX184 + PBO → IDX184 + IDX320IDX320 + PBO → IDX320 + IDX184
IDX184 placeboDRUG

IDX184 matching placebo in capsules administered orally once daily

IDX320 + PBO → IDX320 + IDX184IDX320 PBO + IDX184 PBO
IDX320 placeboDRUG

IDX320 matching placebo in tablets administered orally once daily

IDX184 + PBO → IDX184 + IDX320IDX320 PBO + IDX184 PBO

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To participate in the study, participants must meet the following requirements:
  • Must be a healthy male or female between 19 and 65 years of age with body mass index (BMI) between 18 and 35 kg/m2.
  • Must be a non-smoker.
  • Must agree to use an acceptable double-barrier method of birth control.
  • Must provide written informed consent after the study has been fully explained.

You may not qualify if:

  • Participants are not eligible if they meet any of the following:
  • Pregnant or breastfeeding.
  • History of clinically significant diseases, as determined by the investigator.
  • Safety laboratory abnormalities at screening which are clinically significant.
  • Positive screening test for hepatitis B virus, hepatitis C virus or human immunodeficiency virus (HIV).
  • Use of chronic prescription medications within 3 months, acute prescription medications within 14 days, or systemic over-the-counter (OTC) medications within 7 days of the starting the study.
  • Current abuse of alcohol or illicit drugs, or history of alcohol or illicit drug abuse within the preceding two years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis C, ChronicHepatitis C

Interventions

IDX320IDX184

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
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2010

First Posted

July 5, 2010

Study Start

June 1, 2010

Primary Completion

July 1, 2010

Study Completion

August 1, 2010

Last Updated

January 22, 2016

Record last verified: 2016-01