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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00730431
First received: August 5, 2008
Last updated: January 7, 2015
Last verified: January 2015
  Purpose

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.


Condition Intervention Phase
Hepatitis C
Drug: IDX184
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percentage of participants experiencing serious adverse events (SAEs) [ Time Frame: Up to Day 6 ] [ Designated as safety issue: Yes ]
  • Percentage of participants experiencing AEs [ Time Frame: Up to Day 6 ] [ Designated as safety issue: Yes ]
  • Percentage of participants experiencing dose-limiting toxicity (DLTs) [ Time Frame: Up to Day 6 ] [ Designated as safety issue: Yes ]
  • Percentage of participants experiencing grade 1-4 laboratory abnormalities [ Time Frame: Up to Day 6 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 48
Study Start Date: July 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730431

Locations
United States, Nebraska
Lincoln, Nebraska, United States
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00730431     History of Changes
Other Study ID Numbers: 2355-002, IDX-08C-002
Study First Received: August 5, 2008
Last Updated: January 7, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Hepatitis C, healthy volunteers

ClinicalTrials.gov processed this record on March 26, 2015