Drug-Drug Interaction Between IDX719, Simeprevir, TMC647055 and Ritonavir When Administered in Combination in Healthy Participants (MK-1894-007)

A Phase I, Randomized, Multiple-Dose Study to Evaluate the Pharmacokinetic Drug-Drug Interaction Between IDX719, Simeprevir, TMC647055 and Ritonavir When Administered in Combination in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01907724

Enrollment

Registered

2013-07-25

Start date

2013-05-31

Completion date

2013-08-31

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

Hepatitis C, Chronic

Keywords

Chronic hepatitis C, Hepatitis C virus, HCV

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.

Interventions

DRUGIDX719

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

DRUGSimeprevir

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

DRUGTMC647055

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

DRUGRTV

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Observed terminal half-life (T1/2)	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 maximum plasma drug concentration (Cmax)	Up to 14 days
Time to maximum concentration (Tmax)	Up to 14 days

Secondary

Measure	Time frame
Percentage of participants experiencing adverse events (AEs)	Up to 28 days
Percentage of participants with Grade 1-4 laboratory abnormalities	Up to 28 days
Percentage of participants experiencing serious adverse events (SAEs)	Up to 28 days

Outcome results

None listed

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