Single-Dose Escalation Study of IDX184 in Healthy Volunteers (MK-2355-002)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Hepatitis C

Treatments: Drug: IDX184; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00730431

IDX-08C-002

2355-002

Details and patient eligibility

About

The purpose of this study is to obtain single dose safety and pharmacokinetic (PK) data of IDX184 in humans. No formal hypotheses are to be tested in this study.

Enrollment: 48 estimated patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants are in general good health.
• All participants of childbearing potential must have agreed to use a consistent form of an acceptable double-barrier method of birth control

Exclusion criteria

• Participant is pregnant or breastfeeding.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 7 patient groups, including a placebo group

IDX184 5 mg

Experimental group

Description:

Healthy participants will be administered a single 5 mg dose of IDX184.

Treatment:

Drug: IDX184

IDX184 10 mg

Experimental group

Description:

Healthy participants will be administered a single 10 mg dose of IDX184.

Treatment:

Drug: IDX184

IDX184 25 mg

Experimental group

Description:

Healthy participants will be administered a single 25 mg dose of IDX184.

Treatment:

Drug: IDX184

IDX184 50 mg

Experimental group

Description:

Healthy participants will be administered a single 50 mg dose of IDX184.

Treatment:

Drug: IDX184

IDX184 75 mg

Experimental group

Description:

Healthy participants will be administered a single 75 mg dose of IDX184.

Treatment:

Drug: IDX184

IDX184 100 mg

Experimental group

Description:

Healthy participants will be administered a single 100 mg dose of IDX184.

Treatment:

Drug: IDX184

Placebo

Placebo Comparator group

Description:

Healthy participants will be administered placebo matching IDX184.

Treatment:

Drug: Placebo