---
title: Study to Evaluate Drug-Drug Interaction Between IDX719 and Simeprevir in Healthy Participants (MK-1894-004)
nct_id: NCT01813513
overall_status: COMPLETED
phase: PHASE1
sponsor: Merck Sharp & Dohme LLC
study_type: INTERVENTIONAL
primary_condition: Chronic Hepatitis C Infection
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01813513.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01813513"
ct_last_update_post_date: 2016-01-26
last_seen_at: "2026-05-12T06:54:52.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Study to Evaluate Drug-Drug Interaction Between IDX719 and Simeprevir in Healthy Participants (MK-1894-004)

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

**NCT ID:** [NCT01813513](https://clinicaltrials.gov/study/NCT01813513)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 42
- **Lead Sponsor:** Merck Sharp & Dohme LLC
- **Conditions:** Chronic Hepatitis C Infection
- **Start Date:** 2013-01
- **Completion Date:** 2013-07
- **CT.gov Last Update:** 2016-01-26

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **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
```

## Arms

- **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.
- **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.
- **Group C: IDX719** (EXPERIMENTAL) — Healthy participants take IDX719 150 mg QD on Days 1-14.
- **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.
- **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).
- **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).

## Interventions

- **IDX719** (DRUG) — 50 mg tablet for oral administration
- **Simeprevir** (DRUG) — 150 mg capsule for oral administration

## Primary Outcomes

- **Area under the plasma concentration-time curve (AUC) at steady-state over dosing interval (AUCss)** _(time frame: Up to 30 days)_
- **Maximum observed plasma concentration (Cmax)** _(time frame: Up to 30 days)_
- **AUC from time zero to infinity** _(time frame: Up to 30 days)_
- **Trough plasma concentration (Ctrough)** _(time frame: Up to 30 days)_

## Secondary Outcomes

- **Percentage of participants experiencing serious adverse events (SAEs)** _(time frame: Up to 30 days)_
- **Percentage of participants experiencing adverse events (AEs)** _(time frame: Up to 30 days)_
- **Percentage of participants experiencing Grade 1-4 laboratory abnormalities** _(time frame: Up to 30 days)_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01813513.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01813513*  
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