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

NCT ID: NCT01646489

Last Updated: 2012-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-09-30

Brief Summary

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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

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Conditions

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Hepatitis C Chronic Hepatitis C

Keywords

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Antisense miR-122 antagonist Safety in healthy volunteers Hepatitis C

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Miravirsen sodium

Group Type EXPERIMENTAL

Miravirsen sodium

Intervention Type DRUG

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

Telaprevir

Group Type ACTIVE_COMPARATOR

Telaprevir

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Telaprevir

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

Intervention Type DRUG

Other Intervention Names

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Miravirsen SPC3649 Incivek

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Santaris Pharma A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul Rice, MD

Role: PRINCIPAL_INVESTIGATOR

Spaulding Clinical Research LLC

Locations

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Spaulding Clinical Research

West Bend, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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SPC3649-206

Identifier Type: -

Identifier Source: org_study_id