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

Hepatitis C, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01907724
• Other study ID #: 1894-007
• Secondary ID: IDX-06A-007
• Status: Completed
• Phase: Phase 1
• First received: June 4, 2013
• Last updated: January 25, 2016
• Start date: May 2013
• Est. completion date: August 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 65 Years

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• IDX719
IDX719 will be supplied as a 50 mg tablet for oral administration.
• Simeprevir
Simeprevir will be supplied as 75 mg capsules for oral administration.
• TMC647055
TMC647055 will be supplied as 150 mg capsules for oral administration.
• RTV
RTV will be supplied as 80 mg/mL solution for oral administration.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.	Janssen Research & Development, LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observed maximum plasma drug concentration (Cmax)		Up to 14 days	No
Primary	Time to maximum concentration (Tmax)		Up to 14 days	No
Primary	Area under the drug concentration-plasma time curve from time zero to last measurable concentration (AUC0-t)		Up to 14 days	No
Primary	Predose trough concentration (Ctrough)		Up to 14 days	No
Primary	Apparent terminal elimination rate constant		Up to 14 days	No
Primary	Observed terminal half-life (T1/2)		Up to 14 days	No
Secondary	Percentage of participants experiencing serious adverse events (SAEs)		Up to 28 days	Yes
Secondary	Percentage of participants experiencing adverse events (AEs)		Up to 28 days	Yes
Secondary	Percentage of participants with Grade 1-4 laboratory abnormalities		Up to 28 days	Yes