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

Chronic Hepatitis C Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01813513
• Other study ID #: 1894-004
• Secondary ID: IDX-06A-004
• Status: Completed
• Phase: Phase 1
• First received: March 13, 2013
• Last updated: January 25, 2016
• Start date: January 2013
• Est. completion date: July 2013

Study information

• Verified date: January 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C Infection
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• IDX719
50 mg tablet for oral administration
• Simeprevir
150 mg capsule for oral administration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration-time curve (AUC) at steady-state over dosing interval (AUCss)		Up to 30 days	No
Primary	Maximum observed plasma concentration (Cmax)		Up to 30 days	No
Primary	AUC from time zero to infinity		Up to 30 days	No
Primary	Trough plasma concentration (Ctrough)		Up to 30 days	No
Secondary	Percentage of participants experiencing serious adverse events (SAEs)		Up to 30 days	Yes
Secondary	Percentage of participants experiencing adverse events (AEs)		Up to 30 days	Yes
Secondary	Percentage of participants experiencing Grade 1-4 laboratory abnormalities		Up to 30 days	Yes