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
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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