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

April 22, 2015 updated by: Merck Sharp & Dohme LLC

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: IDX184 5 mg
Healthy participants will be administered a single 5 mg dose of IDX184.
Drug: IDX184
IDX184 supplied as size 3, white opaque capsules containing either 5 mg or 25 mg.
EXPERIMENTAL: IDX184 10 mg
Healthy participants will be administered a single 10 mg dose of IDX184.
Drug: IDX184
IDX184 supplied as size 3, white opaque capsules containing either 5 mg or 25 mg.
EXPERIMENTAL: IDX184 25 mg
Healthy participants will be administered a single 25 mg dose of IDX184.
Drug: IDX184
IDX184 supplied as size 3, white opaque capsules containing either 5 mg or 25 mg.
EXPERIMENTAL: IDX184 50 mg
Healthy participants will be administered a single 50 mg dose of IDX184.
Drug: IDX184
IDX184 supplied as size 3, white opaque capsules containing either 5 mg or 25 mg.
EXPERIMENTAL: IDX184 75 mg
Healthy participants will be administered a single 75 mg dose of IDX184.
Drug: IDX184
IDX184 supplied as size 3, white opaque capsules containing either 5 mg or 25 mg.
EXPERIMENTAL: IDX184 100 mg
Healthy participants will be administered a single 100 mg dose of IDX184.
Drug: IDX184
IDX184 supplied as size 3, white opaque capsules containing either 5 mg or 25 mg.
PLACEBO_COMPARATOR: Placebo
Healthy participants will be administered placebo matching IDX184.
Drug: Placebo
Placebo supplied as size 3, white opaque capsules matching IDX184 capsules.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (ACTUAL)

October 1, 2008

Study Completion (ACTUAL)

October 1, 2008

Study Registration Dates

First Submitted

August 5, 2008

First Submitted That Met QC Criteria

August 7, 2008

First Posted (ESTIMATE)

August 8, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

April 23, 2015

Last Update Submitted That Met QC Criteria

April 22, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2355-002
  • IDX-08C-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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