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IDX320

Phase 1

Chronic Hepatitis C | Small molecule | Infectious Disease |Merck & Company, Inc.|Last Updated: Jan 22, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

IDX320 · 1 trial · 1 indication

Phase 1 1
NCT01157104A Drug-Drug Interaction Study Evaluating the Combination of IDX320 and IDX184 in Healthy Participants (MK-6844-002)Chronic Hepatitis C
COMPLETED20 Analytics
PHASE1COMPLETED
A Drug-Drug Interaction Study Evaluating the Combination of IDX320 and IDX184 in Healthy Participants (MK-6844-002)
Chronic Hepatitis CUnlock trial analytics

Study Endpoints

Primary Endpoints

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

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
IDX320 + PBO → IDX320 + IDX184EXPERIMENTAL400 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
IDX184 + PBO → IDX184 + IDX320EXPERIMENTAL100 mg IDX184 and IDX320 matching PBO for 7 days; followed by 100 mg IDX184 and 400 mg IDX320 for 7 days
IDX320 PBO + IDX184 PBOPLACEBO_COMPARATORIDX320 matching PBO + IDX184 matching PBO for 14 days

Interventions

NameTypeDescription
IDX320DRUGIDX320 400 mg in tablets (8x50 mg) administered orally once daily
IDX184DRUGIDX184 100 mg in capsules (2x50 mg) administered orally once daily
IDX184 placeboDRUGIDX184 matching placebo in capsules administered orally once daily
IDX320 placeboDRUGIDX320 matching placebo in tablets administered orally once daily
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Eligibility Criteria

Age Range19 Years to 65 Years
SexALL
Healthy VolunteersYes

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 meth...

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Frequently asked questions about IDX320

What is IDX320 used for?

IDX320 is an investigational small molecule being developed for the treatment of Chronic Hepatitis C. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes IDX320?

IDX320 is being developed by Merck & Company, Inc., which is publicly traded under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy.

What phase is IDX320 in?

IDX320 is in Phase 1 clinical development. It is an investigational drug and has not yet received regulatory approval. The drug is being studied for its potential use in treating Chronic Hepatitis C.

What clinical trials is IDX320 in?

IDX320 has one completed clinical trial, NCT01157104, which was a Phase 1 drug-drug interaction study evaluating the combination of IDX320 and IDX184 in healthy participants. The trial enrolled 20 participants and was placebo-controlled and double-blind.

Is IDX320 FDA approved?

IDX320 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Chronic Hepatitis C. The drug has not yet completed the clinical trials necessary to support a marketing application.