Study to Evaluate Drug-Drug Interaction Between IDX719 and Simeprevir in Healthy Participants (MK-1894-004)

A Phase I, Randomized, Multiple-Dose Study to Evaluate the Pharmacokinetic Drug-Drug Interaction Between IDX719 and Simeprevir in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01813513

Enrollment

Registered

2013-03-19

Start date

2013-01-31

Completion date

2013-07-31

Last updated

2016-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C Infection

Keywords

HCV, Hepatitis C Virus, Hepatitis C, antiviral drugs, liver

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.

Interventions

DRUGIDX719

50 mg tablet for oral administration

DRUGSimeprevir

150 mg capsule for oral administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Percentage of participants experiencing Grade 1-4 laboratory abnormalities	Up to 30 days
Percentage of participants experiencing serious adverse events (SAEs)	Up to 30 days
Percentage of participants experiencing adverse events (AEs)	Up to 30 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026