A Phase I, Double-Blind, Multiple-Dose Study to Evaluate the Pharmacokinetic Drug-Drug Interaction Between IDX320 and IDX184 in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- IDX320
- Conditions
- Chronic Hepatitis C
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 20
- Primary Endpoint
- Area under the curve at steady state (AUCss) of plasma IDX320
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
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/m
- •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.
Arms & Interventions
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
Intervention: IDX320
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
Intervention: IDX184
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
Intervention: IDX184 placebo
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
Intervention: IDX320
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
Intervention: IDX184
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
Intervention: IDX320 placebo
IDX320 PBO + IDX184 PBO
IDX320 matching PBO + IDX184 matching PBO for 14 days
Intervention: IDX184 placebo
IDX320 PBO + IDX184 PBO
IDX320 matching PBO + IDX184 matching PBO for 14 days
Intervention: IDX320 placebo
Outcomes
Primary Outcomes
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
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
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
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
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
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
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
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
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
Secondary Outcomes
- Number of participants with an adverse event (AE)(Up to Day 19)
- Number of participants who discontinued treatment due to an AE(Up to Day 14)