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

A Phase I, Randomized, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of IDX184 After Oral Administration in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00730431

Enrollment

Registered

2008-08-08

Start date

2008-07-31

Completion date

2008-10-31

Last updated

2015-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

Keywords

Hepatitis C, healthy volunteers

Brief summary

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.

Interventions

DRUGIDX184

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

19 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Percentage of participants experiencing serious adverse events (SAEs)	Up to Day 6
Percentage of participants experiencing AEs	Up to Day 6
Percentage of participants experiencing dose-limiting toxicity (DLTs)	Up to Day 6
Percentage of participants experiencing grade 1-4 laboratory abnormalities	Up to Day 6

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026