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

Phase 1

Completed

• Conditions: Hepatitis C
• Interventions: Drug: IDX184; Drug: Placebo

• Registration Number: NCT00730431
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-08-05
• Study First Submitted QC: 2008-08-07
• Study First Posted: 2008-08-08
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-22
• Last Update Posted: 2015-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

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Exclusion Criteria

• Participant is pregnant or breastfeeding.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IDX184 50 mg	IDX184	Healthy participants will be administered a single 50 mg dose of IDX184.
IDX184 75 mg	IDX184	Healthy participants will be administered a single 75 mg dose of IDX184.
IDX184 25 mg	IDX184	Healthy participants will be administered a single 25 mg dose of IDX184.
IDX184 10 mg	IDX184	Healthy participants will be administered a single 10 mg dose of IDX184.
IDX184 100 mg	IDX184	Healthy participants will be administered a single 100 mg dose of IDX184.
IDX184 5 mg	IDX184	Healthy participants will be administered a single 5 mg dose of IDX184.
Placebo	Placebo	Healthy participants will be administered placebo matching IDX184.

Primary Outcome Measures

Name	Time	Method
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