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

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Completed
Phase 1

Conditions

Chronic Hepatitis C

Treatments

Drug: IDX184 placebo
Drug: IDX184
Drug: IDX320
Drug: IDX320 placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01157104
6844-002
IDX-07A-002 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

19 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

20 participants in 3 patient groups, including a placebo group

IDX320 + PBO → IDX320 + IDX184
Experimental group
Description:
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
Treatment:
Drug: IDX184 placebo
Drug: IDX184
Drug: IDX320
IDX184 + PBO → IDX184 + IDX320
Experimental group
Description:
100 mg IDX184 and IDX320 matching PBO for 7 days; followed by 100 mg IDX184 and 400 mg IDX320 for 7 days
Treatment:
Drug: IDX320 placebo
Drug: IDX184
Drug: IDX320
IDX320 PBO + IDX184 PBO
Placebo Comparator group
Description:
IDX320 matching PBO + IDX184 matching PBO for 14 days
Treatment:
Drug: IDX320 placebo
Drug: IDX184 placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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