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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Chronic Hepatitis C

Treatments: Drug: IDX184 placebo; Drug: IDX184; Drug: IDX320; Drug: IDX320 placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01157104

6844-002

IDX-07A-002 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 3 patient groups, including a placebo group

IDX320 + PBO → IDX320 + IDX184

Experimental group

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

Treatment:

Drug: IDX184 placebo

Drug: IDX184

Drug: IDX320

IDX184 + PBO → IDX184 + IDX320

Experimental group

Description:

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

Treatment:

Drug: IDX320 placebo

Drug: IDX184

Drug: IDX320

IDX320 PBO + IDX184 PBO

Placebo Comparator group

Description:

IDX320 matching PBO + IDX184 matching PBO for 14 days

Treatment:

Drug: IDX320 placebo

Drug: IDX184 placebo