A Phase I, Double-Blind, Multiple-Dose Study to Evaluate the Pharmacokinetic Drug-Drug Interaction Between IDX320 and IDX184 in Healthy Subjects

Merck Sharp & Dohme LLC0 sites20 target enrollmentStarted: June 2010Last updated: January 22, 2016

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Phase 1
Status: Completed
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 20
Primary Endpoint: Area under the curve at steady state (AUCss) of plasma IDX320

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Records & Identifiers Similar Trials

Study Overview

Brief Summary

This study is designed to evaluate the potential for a pharmacokinetic (PK) drug-drug interaction between IDX320 and IDX184 and to assess the safety and tolerability when the two drugs are administered in combination in healthy participants.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Crossover
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Eligibility Criteria

Ages: 19 Years to 65 Years (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: Yes

Inclusion Criteria

•To participate in the study, participants must meet the following requirements:
•Must be a healthy male or female between 19 and 65 years of age with body mass index (BMI) between 18 and 35 kg/m
•Must be a non-smoker.
•Must agree to use an acceptable double-barrier method of birth control.
•Must provide written informed consent after the study has been fully explained.

Exclusion Criteria

•Participants are not eligible if they meet any of the following:
•Pregnant or breastfeeding.
•History of clinically significant diseases, as determined by the investigator.
•Safety laboratory abnormalities at screening which are clinically significant.
•Positive screening test for hepatitis B virus, hepatitis C virus or human immunodeficiency virus (HIV).
•Use of chronic prescription medications within 3 months, acute prescription medications within 14 days, or systemic over-the-counter (OTC) medications within 7 days of the starting the study.
•Current abuse of alcohol or illicit drugs, or history of alcohol or illicit drug abuse within the preceding two years.

Arms & Interventions

IDX320 + PBO → IDX320 + IDX184

Experimental

400 mg IDX320 and IDX184 matching placebo (PBO) once daily for 7 days; followed by 400 mg IDX320 and 100 mg IDX184 once daily for 7 days

Intervention: IDX320 (Drug)

IDX320 + PBO → IDX320 + IDX184

Experimental

400 mg IDX320 and IDX184 matching placebo (PBO) once daily for 7 days; followed by 400 mg IDX320 and 100 mg IDX184 once daily for 7 days

Intervention: IDX184 (Drug)

IDX320 + PBO → IDX320 + IDX184

Experimental

400 mg IDX320 and IDX184 matching placebo (PBO) once daily for 7 days; followed by 400 mg IDX320 and 100 mg IDX184 once daily for 7 days

Intervention: IDX184 placebo (Drug)

IDX184 + PBO → IDX184 + IDX320

Experimental

100 mg IDX184 and IDX320 matching PBO for 7 days; followed by 100 mg IDX184 and 400 mg IDX320 for 7 days

Intervention: IDX320 (Drug)

IDX184 + PBO → IDX184 + IDX320

Experimental

100 mg IDX184 and IDX320 matching PBO for 7 days; followed by 100 mg IDX184 and 400 mg IDX320 for 7 days

Intervention: IDX184 (Drug)

IDX184 + PBO → IDX184 + IDX320

Experimental

100 mg IDX184 and IDX320 matching PBO for 7 days; followed by 100 mg IDX184 and 400 mg IDX320 for 7 days

Intervention: IDX320 placebo (Drug)

IDX320 PBO + IDX184 PBO

Placebo Comparator

IDX320 matching PBO + IDX184 matching PBO for 14 days

Intervention: IDX184 placebo (Drug)

IDX320 PBO + IDX184 PBO

Placebo Comparator

IDX320 matching PBO + IDX184 matching PBO for 14 days

Intervention: IDX320 placebo (Drug)