Overview

A Drug-Drug Interaction Study Evaluating the Combination of IDX320 and IDX184 in Healthy Participants (MK-6844-002)

Status:
Completed
Trial end date:
2010-08-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
Criteria
Inclusion Criteria:

To participate in the study, participants must meet the following requirements:

1. Must be a healthy male or female between 19 and 65 years of age with body mass index
(BMI) between 18 and 35 kg/m2.

2. Must be a non-smoker.

3. Must agree to use an acceptable double-barrier method of birth control.

4. 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:

1. Pregnant or breastfeeding.

2. History of clinically significant diseases, as determined by the investigator.

3. Safety laboratory abnormalities at screening which are clinically significant.

4. Positive screening test for hepatitis B virus, hepatitis C virus or human
immunodeficiency virus (HIV).

5. 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.

6. Current abuse of alcohol or illicit drugs, or history of alcohol or illicit drug abuse
within the preceding two years.