NCT01646489

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

A Phase 1, Open-Label, Drug Interaction Study to Assess Safety, Tolerability, and Pharmacokinetics of Co-Administered Miravirsen and Telaprevir in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Santaris Pharma A/S · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2012-06-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2012-07-20
• Last updated: 2012-11-12

Locations

1 site across 1 country: United States