NCT01907724

Brief Summary

The purpose of this study is to evaluate the potential for a PK drug-drug interaction when IDX719, simeprevir, TMC647055 and low-dose ritonavir (RTV) are administered in combination. Safety and tolerability will also be assessed.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2013

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

May 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 4, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 25, 2013

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

January 26, 2016

Status Verified

January 1, 2016

Enrollment Period

3 months

First QC Date

June 4, 2013

Last Update Submit

January 25, 2016

Conditions

Hepatitis C, Chronic

Keywords

Chronic hepatitis CHepatitis C virusHCV

Outcome Measures

Primary Outcomes (6)

  • Observed maximum plasma drug concentration (Cmax)

    Up to 14 days

  • Time to maximum concentration (Tmax)

    Up to 14 days

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

    Up to 14 days

  • Predose trough concentration (Ctrough)

    Up to 14 days

  • Apparent terminal elimination rate constant

    Up to 14 days

  • Observed terminal half-life (T1/2)

    Up to 14 days

Secondary Outcomes (3)

  • Percentage of participants experiencing serious adverse events (SAEs)

    Up to 28 days

  • Percentage of participants experiencing adverse events (AEs)

    Up to 28 days

  • Percentage of participants with Grade 1-4 laboratory abnormalities

    Up to 28 days

Study Arms (2)

IDX719 + RTV

EXPERIMENTAL

Participants take IDX719 150 mg once daily (QD) + ritonavir 30 mg QD on Days 1-7, and then take IDX719 150 mg QD + simeprevir 75 mg QD + TMC647055 450 mg QD + RTV 30 mg QD on Days 8-14.

Drug: IDX719Drug: SimeprevirDrug: TMC647055Drug: RTV

Simeprevir/TMC647055 + RTV

EXPERIMENTAL

Participants take simeprevir 75 mg QD + TMC647055 450 mg QD + RTV 30 mg QD on Days 1-7, and then take IDX719 150 mg QD + simeprevir 75 mg QD + TMC647055 450 mg QD + RTV 30 mg QD on Days 8-14.

Drug: IDX719Drug: SimeprevirDrug: TMC647055Drug: RTV

Interventions

IDX719DRUG

IDX719 will be supplied as a 50 mg tablet for oral administration.

IDX719 + RTVSimeprevir/TMC647055 + RTV
SimeprevirDRUG

Simeprevir will be supplied as 75 mg capsules for oral administration.

Also known as: Olysio™
IDX719 + RTVSimeprevir/TMC647055 + RTV
TMC647055DRUG

TMC647055 will be supplied as 150 mg capsules for oral administration.

IDX719 + RTVSimeprevir/TMC647055 + RTV
RTVDRUG

RTV will be supplied as 80 mg/mL solution for oral administration.

Also known as: Norvir™
IDX719 + RTVSimeprevir/TMC647055 + RTV

Eligibility Criteria

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

You may qualify if:

  • Agrees to use a double method of birth control (one of which must be a barrier) from Screening through at least 90 days after the last dose of the study drug
  • Male participants agree not to donate sperm from Day -1 through 90 days after the last dose of study drug

You may not qualify if:

  • Is pregnant or breastfeeding
  • Has another clinically significant medical conditions or laboratory abnormality(s)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis C, ChronicHepatitis C

Interventions

samatasvirSimeprevir27-cyclohexyl-12,13,16,17-tetrahydro-22-methoxy-11,17-dimethyl-10,10-dioxide-2,19-methano-3,7:4,1-dimetheno-1H,11H-14,10,2,9,11,17-benzoxathiatetraazacyclo docosine-8,18(9H,15H)-dioneRitonavir

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

SulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsThiazolesAzolesHeterocyclic Compounds, 1-Ring

Study Officials

  • Medical Director

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2013

First Posted

July 25, 2013

Study Start

May 1, 2013

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

January 26, 2016

Record last verified: 2016-01