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

Merck Sharp & Dohme LLC48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Hepatitis C

Interventions

IDX184DRUG

IDX184 supplied as size 3, white opaque capsules containing either 5 mg or 25 mg.

PlaceboDRUG

Placebo supplied as size 3, white opaque capsules matching IDX184 capsules.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Percentage of participants experiencing serious adverse events (SAEs)

Time frame: Up to Day 6

Percentage of participants experiencing AEs

Time frame: Up to Day 6

Percentage of participants experiencing dose-limiting toxicity (DLTs)

Time frame: Up to Day 6

Percentage of participants experiencing grade 1-4 laboratory abnormalities

Time frame: Up to Day 6

Data from ClinicalTrials.gov

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