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Completed

NCT Number: NCT01157104

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

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.

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Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

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.

Treatment and study plan

IDX320

Drug

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

IDX184

Drug

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

IDX184 placebo

Drug

IDX184 matching placebo in capsules administered orally once daily

IDX320 placebo

Drug

IDX320 matching placebo in tablets administered orally once daily

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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase I, Double-Blind, Multiple-Dose Study to Evaluate the Pharmacokinetic Drug-Drug Interaction Between IDX320 and IDX184 in Healthy Subjects

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jul 5, 2010
Registry last updated
Jan 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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