Overview
A Drug-Drug Interaction Study Evaluating the Combination of IDX320 and IDX184 in Healthy Participants (MK-6844-002)
Status:
Completed
Completed
Trial end date:
2010-08-01
2010-08-01
Target enrollment:
0
0
Participant gender:
All
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 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
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.