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

Santaris Pharma

Status and phase: Completed; Phase 1

Conditions: Hepatitis C; Chronic Hepatitis C

Treatments: Drug: Telaprevir; Drug: Miravirsen sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT01646489

SPC3649-206

Details and patient eligibility

About

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

Enrollment: 5 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Miravirsen sodium

Experimental group

Treatment:

Drug: Miravirsen sodium

Telaprevir

Active Comparator group

Treatment:

Drug: Telaprevir