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

Santaris Pharma A/S5 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis C Chronic Hepatitis C

Interventions

Miravirsen sodiumDRUG

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

TelaprevirDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Spaulding Clinical Research

West Bend, Wisconsin, United States

Outcomes

Primary Outcomes

The effect of miravirsen on telaprevir pharmacokinetics as determined by AUC0-24h, Cmax and tmax.

Time frame: Up to 24 hours after dosing.

Safety and tolerability of co-administered miravirsen and telaprevir.

Safety and tolerability will be assessed by evaluation of adverse events, physical examinations, vital signs, clinical safety laboratory assessments and electrocardiograms.

Time frame: 12 weeks

Secondary Outcomes

The effect of telaprevir on miravirsen pharmacokinetics as determined by AUC0-24h, Cmax and tmax.

Time frame: Up to 24 hours after dosing.

Data from ClinicalTrials.gov

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