Drug Interaction Study to Assess the Effect of Co-Administered Miravirsen and Telaprevir in Healthy Subjects

NCT01646489 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2012-11-12

No results posted yet for this study

Summary

The purpose of this study is to assess the safety, tolerability, and affect on blood levels of miravirsen and telaprevir when administered together.

Conditions

  • Hepatitis C
  • Chronic Hepatitis C

Interventions

DRUG

Miravirsen sodium

Miravirsen 7 mg/kg to be administered as single subcutaneous injections for a total of 5 doses over a 5 week treatment period.

DRUG

Telaprevir

Telaprevir 750 mg to be administered as single and multiple oral doses over two 7 day treatment periods.

Sponsors & Collaborators

  • Santaris Pharma A/S

    lead INDUSTRY

Principal Investigators

  • Paul Rice, MD · Spaulding Clinical Research LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01646489 on ClinicalTrials.gov