Study Assessing Single and Multiple Doses of IDX21459 in Healthy and HCV-Infected Subjects

Chronic Hepatitis C Clinical Trial

Official title:

A Phase I Study Assessing Single and Multiple Doses of IDX21459 in Healthy and HCV-Infected Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02112942
• Other study ID #: 7822-001
• Secondary ID: IDX-04C-001
• Status: Terminated
• Phase: Phase 1
• First received: April 10, 2014
• Last updated: January 25, 2016
• Start date: March 2014
• Est. completion date: June 2014

Study information

• Verified date: January 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

A multi-part study to evaluate the safety and PK of single ascending doses of IDX21549 in healthy and HCV-infected subjects. The effect of food on the PK of IDX21549 will also be evaluated. Antiviral activity will also be assessed in HCV-infected subjects.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

All subjects

• Subjects are in good general health.

• Subjects have provided written informed consent form.

• All subjects of childbearing potential must have agreed to use a double method of birth control (one of which must be a barrier) from Screening through at least 90 days after the last dose of the study drug. HCV Subjects

• Documented clinical history compatible with chronic hepatitis C without cirrhosis.

• Treatment-naïve

• HCV Genotype 1

Exclusion Criteria:

All subjects

• Pregnant or breastfeeding

• Co-infected with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV).

• Decompensated liver disease

• Other clinically significant medical conditions or laboratory abnormalities.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• IDX21459

• Matching Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability assessment	Proportion of subjects experiencing adverse events.	up to 35 days	Yes
Secondary	Pharmacokinetic	Plasma and urine concentrations of IDX21459 and its metabolite/s.	Up to 120 hours post dose	No