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

NCT ID: NCT00730431

Last Updated: 2015-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2008-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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IDX184 5 mg

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

Group Type EXPERIMENTAL

IDX184

Intervention Type DRUG

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

IDX184 10 mg

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

Group Type EXPERIMENTAL

IDX184

Intervention Type DRUG

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

IDX184 25 mg

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

Group Type EXPERIMENTAL

IDX184

Intervention Type DRUG

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

IDX184 50 mg

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

Group Type EXPERIMENTAL

IDX184

Intervention Type DRUG

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

IDX184 75 mg

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

Group Type EXPERIMENTAL

IDX184

Intervention Type DRUG

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

IDX184 100 mg

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

Group Type EXPERIMENTAL

IDX184

Intervention Type DRUG

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

Placebo

Healthy participants will be administered placebo matching IDX184.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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IDX184

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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Zhou XJ, Pietropaolo K, Chen J, Khan S, Sullivan-Bolyai J, Mayers D. Safety and pharmacokinetics of IDX184, a liver-targeted nucleotide polymerase inhibitor of hepatitis C virus, in healthy subjects. Antimicrob Agents Chemother. 2011 Jan;55(1):76-81. doi: 10.1128/AAC.01101-10. Epub 2010 Nov 8.

Reference Type RESULT
PMID: 21060109 (View on PubMed)

Other Identifiers

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IDX-08C-002

Identifier Type: -

Identifier Source: secondary_id

2355-002

Identifier Type: -

Identifier Source: org_study_id

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