Status:

COMPLETED

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

Lead Sponsor:

Merck Sharp & Dohme LLC

Conditions:

Chronic Hepatitis C

Eligibility:

All Genders

19-65 years

Phase:

PHASE1

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 administere...

Eligibility Criteria

Inclusion

  • 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/m2.
  • 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

  • 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.

Key Trial Info

Start Date :

June 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2010

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT01157104

Start Date

June 1 2010

End Date

August 1 2010

Last Update

January 22 2016

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