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Completed

NCT Number: NCT00730431

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

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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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IDX184

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Percentage of participants experiencing serious adverse events (SAEs)

    Time frame: Up to Day 6

  2. Percentage of participants experiencing AEs

    Time frame: Up to Day 6

  3. Percentage of participants experiencing dose-limiting toxicity (DLTs)

    Time frame: Up to Day 6

  4. Percentage of participants experiencing grade 1-4 laboratory abnormalities

    Time frame: Up to Day 6

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Aug 8, 2008
Registry last updated
Apr 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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