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

Primary Purpose

Chronic Hepatitis C

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

IDX320

IDX184

IDX184 placebo

IDX320 placebo

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring HCV, Hepatitis C

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

IDX320 + PBO → IDX320 + IDX184

IDX184 + PBO → IDX184 + IDX320

IDX320 PBO + IDX184 PBO

Arm 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

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

IDX320 matching PBO + IDX184 matching PBO for 14 days

Outcomes

Primary Outcome Measures

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

AUCss of plasma IDX184

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

Maximum observed concentration (Cmax) of plasma IDX320

Cmax of plasma IDX184

Cmax of plasma 2'-MeG

Trough concentration (Ctrough) of plasma IDX320

Ctrough of plasma IDX184

Ctrough of plasma 2"-MeG

Secondary Outcome Measures

Number of participants with an adverse event (AE)

Number of participants who discontinued treatment due to an AE

Full Information

NCT ID

NCT01157104

First Posted

July 2, 2010

Last Updated

January 20, 2016

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT01157104

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

June 2010 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

5. Study Description

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 administered in combination in healthy participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis C

Keywords

HCV, Hepatitis C

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IDX320 + PBO → IDX320 + IDX184

Arm Type

Experimental

Arm 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

Arm Title

IDX184 + PBO → IDX184 + IDX320

Arm Type

Experimental

Arm Description

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

Arm Title

IDX320 PBO + IDX184 PBO

Arm Type

Placebo Comparator

Arm Description

IDX320 matching PBO + IDX184 matching PBO for 14 days

Intervention Type

Drug

Intervention Name(s)

IDX320

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

IDX184

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

IDX184 placebo

Intervention Description

IDX184 matching placebo in capsules administered orally once daily

Intervention Type

Drug

Intervention Name(s)

IDX320 placebo

Intervention Description

IDX320 matching placebo in tablets administered orally once daily

Primary Outcome Measure Information:

Title

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

Time Frame