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

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Completed
Phase 1

Conditions

Hepatitis C, Chronic

Treatments

Drug: Simeprevir
Drug: IDX719
Drug: RTV
Drug: TMC647055

Study type

Interventional

Funder types

Industry

Identifiers

NCT01907724
IDX-06A-007 (Other Identifier)
1894-007

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

All

Ages

19 to 65 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

34 participants in 2 patient groups

IDX719 + RTV
Experimental group
Description:
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.
Treatment:
Drug: IDX719
Drug: RTV
Drug: TMC647055
Drug: Simeprevir
Simeprevir/TMC647055 + RTV
Experimental group
Description:
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.
Treatment:
Drug: IDX719
Drug: RTV
Drug: TMC647055
Drug: Simeprevir

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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