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

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00730431
• Other study ID #: 2355-002
• Secondary ID: IDX-08C-002
• Status: Completed
• Phase: Phase 1
• First received: August 5, 2008
• Last updated: April 22, 2015
• Start date: July 2008
• Est. completion date: October 2008

Study information

• Verified date: April 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Hepatitis C

Intervention

Drug:
• IDX184
IDX184 supplied as size 3, white opaque capsules containing either 5 mg or 25 mg.
• Placebo
Placebo supplied as size 3, white opaque capsules matching IDX184 capsules.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Zhou XJ, Pietropaolo K, Chen J, Khan S, Sullivan-Bólyai 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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants experiencing serious adverse events (SAEs)		Up to Day 6	Yes
Primary	Percentage of participants experiencing AEs		Up to Day 6	Yes
Primary	Percentage of participants experiencing dose-limiting toxicity (DLTs)		Up to Day 6	Yes
Primary	Percentage of participants experiencing grade 1-4 laboratory abnormalities		Up to Day 6	Yes