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CompletedNCT01157104Updated Jan 22, 2016

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

A Phase 1 interventional study of IDX320 and IDX184 in Chronic Hepatitis C, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 19 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-01-22.

Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
19 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Hepatitis C

Keywords

  • HCV
  • Hepatitis C
03

In context

Hepatitis C

2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.

This study's enrollment of 20 is below the median of 79 across 1,633 interventional studies indexed under Hepatitis C.

Browse Hepatitis C studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    IDX320 + PBO → IDX320 + IDX184

    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

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

  • Experimental
    IDX184 + PBO → IDX184 + IDX320

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

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

  • Placebo comparator
    IDX320 PBO + IDX184 PBO

    IDX320 matching PBO + IDX184 matching PBO for 14 days

    Drug: IDX184 placebo · Drug: IDX320 placebo

Interventions

  • DrugIDX320

    IDX320 400 mg in tablets (8x50 mg) administered orally once daily

  • DrugIDX184

    IDX184 100 mg in capsules (2x50 mg) administered orally once daily

  • DrugIDX184 placebo

    IDX184 matching placebo in capsules administered orally once daily

  • DrugIDX320 placebo

    IDX320 matching placebo in tablets administered orally once daily

06

What researchers measure

Primary outcomes

  1. Area under the curve at steady state (AUCss) of plasma IDX320

    Time frame: Days 1-7 pre-dose; Day 7: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20 hrs postdose; Days 8-14 pre-dose; Day 14: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hrs postdose

  2. AUCss of plasma IDX184

    Time frame: Days 1-7 pre-dose; Day 7: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20 hrs postdose; Days 8-14 pre-dose; Day 14: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hrs postdose

  3. AUCss of plasma 2'-methylguanosine (2'-MeG)

    Time frame: Days 1-7 pre-dose; Day 7: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20 hrs postdose; Days 8-14 pre-dose; Day 14: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hrs postdose

  4. Maximum observed concentration (Cmax) of plasma IDX320

    Time frame: Days 1-7 pre-dose; Day 7: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20 hrs postdose; Days 8-14 pre-dose; Day 14: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hrs postdose

  5. Cmax of plasma IDX184

    Time frame: Days 1-7 pre-dose; Day 7: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20 hrs postdose; Days 8-14 pre-dose; Day 14: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hrs postdose

  6. Cmax of plasma 2'-MeG

    Time frame: Days 1-7 pre-dose; Day 7: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20 hrs postdose; Days 8-14 pre-dose; Day 14: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hrs postdose

  7. Trough concentration (Ctrough) of plasma IDX320

    Time frame: Days 1-7 pre-dose; Day 7: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20 hrs postdose; Days 8-14 pre-dose; Day 14: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hrs postdose

  8. Ctrough of plasma IDX184

    Time frame: Days 1-7 pre-dose; Day 7: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20 hrs postdose; Days 8-14 pre-dose; Day 14: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hrs postdose

  9. Ctrough of plasma 2"-MeG

    Time frame: Days 1-7 pre-dose; Day 7: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20 hrs postdose; Days 8-14 pre-dose; Day 14: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hrs postdose

Secondary outcomes

  1. Number of participants with an adverse event (AE)

    Time frame: Up to Day 19

  2. Number of participants who discontinued treatment due to an AE

    Time frame: Up to Day 14

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01157104
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Jul 5, 2010
Start date
Jun 2010
Primary completion
Jul 2010
Completion
Aug 2010
Last update
Jan 22, 2016

Study contacts

Medical Director
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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