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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Chronic Hepatitis C Infection

Treatments: Drug: IDX719; Drug: Simeprevir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01813513

IDX-06A-004 (Other Identifier)

1894-004

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

42 participants in 6 patient groups

Group A: IDX719 then IDX719/Simeprevir

Experimental group

Description:

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.

Treatment:

Drug: Simeprevir

Drug: IDX719

Group B: Simeprevir then IDX719/Simeprevir

Experimental group

Description:

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

Treatment:

Drug: Simeprevir

Drug: IDX719

Group C: IDX719

Experimental group

Description:

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

Treatment:

Drug: IDX719

Group D: IDX719/Simeprevir

Experimental group

Description:

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.

Treatment:

Drug: Simeprevir

Drug: IDX719

Group E: High-Fat then Low-Fat PK

Experimental group

Description:

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).

Treatment:

Drug: IDX719

Group F: Low-Fat then High-Fat PK

Experimental group

Description:

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).

Treatment:

Drug: IDX719