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

Phase 1

Completed

• Conditions: Hepatitis C; Chronic Hepatitis C
• Interventions: Drug: Miravirsen sodium; Drug: Telaprevir

• Registration Number: NCT01646489
• Lead Sponsor: Santaris Pharma A/S

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-07-04
• Study First Submitted QC: 2012-07-17
• Study First Posted: 2012-07-20
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-09
• Last Update Posted: 2012-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Healthy volunteers
• Weight ≤ 85 kg
• Females of non-childbearing potential (postmenopausal or surgically sterile) or males who are surgically sterile or using an acceptable form of birth control

Exclusion Criteria

• Current, clinically significant illness or medical condition

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Miravirsen sodium	Miravirsen sodium	-
Telaprevir	Telaprevir	-

Primary Outcome Measures

Name	Time	Method
The effect of miravirsen on telaprevir pharmacokinetics as determined by AUC0-24h, Cmax and tmax.	Up to 24 hours after dosing.
Safety and tolerability of co-administered miravirsen and telaprevir.	12 weeks	Safety and tolerability will be assessed by evaluation of adverse events, physical examinations, vital signs, clinical safety laboratory assessments and electrocardiograms.

Secondary Outcome Measures

Name	Time	Method
The effect of telaprevir on miravirsen pharmacokinetics as determined by AUC0-24h, Cmax and tmax.	Up to 24 hours after dosing.

Trial Locations

Locations (1)

Spaulding Clinical Research; 🇺🇸 West Bend, Wisconsin, United States