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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01157104
First received: July 2, 2010
Last updated: January 20, 2016
Last verified: January 2016
  Purpose
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.

Condition Intervention Phase
Chronic Hepatitis C
Drug: IDX320
Drug: IDX184
Drug: IDX184 placebo
Drug: IDX320 placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase I, Double-Blind, Multiple-Dose Study to Evaluate the Pharmacokinetic Drug-Drug Interaction Between IDX320 and IDX184 in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants with an adverse event (AE) [ Time Frame: Up to Day 19 ] [ Designated as safety issue: Yes ]
  • Number of participants who discontinued treatment due to an AE [ Time Frame: Up to Day 14 ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: June 2010
Study Completion Date: August 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
IDX320 400 mg in tablets (8x50 mg) administered orally once daily
Drug: IDX184
IDX184 100 mg in capsules (2x50 mg) administered orally once daily
Drug: IDX184 placebo
IDX184 matching placebo in capsules administered orally once daily
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
IDX320 400 mg in tablets (8x50 mg) administered orally once daily
Drug: IDX184
IDX184 100 mg in capsules (2x50 mg) administered orally once daily
Drug: IDX320 placebo
IDX320 matching placebo in tablets administered orally once daily
Placebo Comparator: IDX320 PBO + IDX184 PBO
IDX320 matching PBO + IDX184 matching PBO for 14 days
Drug: IDX184 placebo
IDX184 matching placebo in capsules administered orally once daily
Drug: IDX320 placebo
IDX320 matching placebo in tablets administered orally once daily

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01157104

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01157104     History of Changes
Other Study ID Numbers: 6844-002  IDX-07A-002 
Study First Received: July 2, 2010
Last Updated: January 20, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
HCV
Hepatitis C

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on August 25, 2016