NCT01813513

Brief Summary

The purpose of this 3-part study is to evaluate the potential impact of simeprevir and food on pharmacokinetics (PK) of IDX719 in healthy participants. Part 1 will evaluate potential PK interactions between IDX719 and simeprevir. Part 2 will evaluate the effect of food on the PK of IDX719 in combination with simeprevir. Part 3 will evaluate the impact of high- versus low-fat meals on the PK of IDX719.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 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

January 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 19, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

January 26, 2016

Status Verified

January 1, 2016

Enrollment Period

6 months

First QC Date

March 13, 2013

Last Update Submit

January 25, 2016

Conditions

Chronic Hepatitis C Infection

Keywords

HCVHepatitis C VirusHepatitis Cantiviral drugsliver

Outcome Measures

Primary Outcomes (4)

  • Area under the plasma concentration-time curve (AUC) at steady-state over dosing interval (AUCss)

    Up to 30 days

  • Maximum observed plasma concentration (Cmax)

    Up to 30 days

  • AUC from time zero to infinity

    Up to 30 days

  • Trough plasma concentration (Ctrough)

    Up to 30 days

Secondary Outcomes (3)

  • Percentage of participants experiencing serious adverse events (SAEs)

    Up to 30 days

  • Percentage of participants experiencing adverse events (AEs)

    Up to 30 days

  • Percentage of participants experiencing Grade 1-4 laboratory abnormalities

    Up to 30 days

Study Arms (6)

Group A: IDX719 then IDX719/Simeprevir

EXPERIMENTAL

Healthy participants take IDX719 150 mg once daily (QD) on Days 1-7 and IDX719 150 mg QD + simeprevir 150 mg QD on Days 8-14.

Drug: IDX719Drug: Simeprevir

Group B: Simeprevir then IDX719/Simeprevir

EXPERIMENTAL

Healthy participants take simeprevir 150 mg QD on Days 1-7 and IDX719 150 mg QD + simeprevir 150 mg QD on Days 8-14.

Drug: IDX719Drug: Simeprevir

Group C: IDX719

EXPERIMENTAL

Healthy participants take IDX719 150 mg QD on Days 1-14.

Drug: IDX719

Group D: IDX719/Simeprevir

EXPERIMENTAL

Participants from Groups A and B will be asked to return for Group D. Participants take IDX719 and simeprevir QD on Days 1-7 to determine the impact of food on single-dose (on Day 1) and steady state (Day 7) PK.

Drug: IDX719Drug: Simeprevir

Group E: High-Fat then Low-Fat PK

EXPERIMENTAL

Participants from Group C will return to determine the PK of IDX719 after high-fat (Day 1) and low-fat (Day 7) meals (Days 2-6 are drug-free washout).

Drug: IDX719

Group F: Low-Fat then High-Fat PK

EXPERIMENTAL

Participants from Group C will return to determine the PK of IDX719 after low-fat (Day 1) and high-fat (Day 7) meals (Days 2-6 are drug-free washout).

Drug: IDX719

Interventions

IDX719DRUG

50 mg tablet for oral administration

Also known as: Samatasvir
Group A: IDX719 then IDX719/SimeprevirGroup B: Simeprevir then IDX719/SimeprevirGroup C: IDX719Group D: IDX719/SimeprevirGroup E: High-Fat then Low-Fat PKGroup F: Low-Fat then High-Fat PK
SimeprevirDRUG

150 mg capsule for oral administration

Also known as: Olysio™
Group A: IDX719 then IDX719/SimeprevirGroup B: Simeprevir then IDX719/SimeprevirGroup D: IDX719/Simeprevir

Eligibility Criteria

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

You may qualify if:

  • Has no clinically significant abnormalities on medical history, physical examination, or 12-lead electrocardiogram (ECG)
  • 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 study drug
  • Agrees to avoid nicotine-containing products from 3 months prior to Screening and for the duration of the study

You may not qualify if:

  • Is positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, or anti-human immunodeficiency virus (HIV) antibodies
  • Is pregnant or breastfeeding
  • Has previously received either IDX719 or simeprevir
  • Has participated in another clinical drug study within 30 days of Screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis C

Interventions

samatasvirSimeprevir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

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

March 13, 2013

First Posted

March 19, 2013

Study Start

January 1, 2013

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

January 26, 2016

Record last verified: 2016-01