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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Chronic Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type EXPERIMENTAL

IDX320

Intervention Type DRUG

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

IDX184

Intervention Type DRUG

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

IDX184 placebo

Intervention Type DRUG

IDX184 matching placebo in capsules administered orally once daily

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

Group Type EXPERIMENTAL

IDX320

Intervention Type DRUG

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

IDX184

Intervention Type DRUG

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

IDX320 placebo

Intervention Type DRUG

IDX320 matching placebo in tablets administered orally once daily

IDX320 PBO + IDX184 PBO

IDX320 matching PBO + IDX184 matching PBO for 14 days

Group Type PLACEBO_COMPARATOR

IDX184 placebo

Intervention Type DRUG

IDX184 matching placebo in capsules administered orally once daily

IDX320 placebo

Intervention Type DRUG

IDX320 matching placebo in tablets administered orally once daily

Interventions

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IDX320

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

Intervention Type DRUG

IDX184

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

Intervention Type DRUG

IDX184 placebo

IDX184 matching placebo in capsules administered orally once daily

Intervention Type DRUG

IDX320 placebo

IDX320 matching placebo in tablets administered orally once daily

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes