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

November 9, 2012 updated by: Santaris Pharma A/S

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • West Bend, Wisconsin, United States, 53095
        • Spaulding Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Miravirsen sodium
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.
Other Names:
  • SPC3649
  • Miravirsen
Active Comparator: Telaprevir
Drug: Telaprevir
Telaprevir 750 mg to be administered as single and multiple oral doses over two 7 day treatment periods.
Other Names:
  • Incivek

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Santaris Pharma A/S

Investigators

  • Principal Investigator: Paul Rice, MD, Spaulding Clinical Research LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

July 4, 2012

First Submitted That Met QC Criteria

July 17, 2012

First Posted (Estimate)

July 20, 2012

Study Record Updates

Last Update Posted (Estimate)

November 12, 2012

Last Update Submitted That Met QC Criteria

November 9, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPC3649-206

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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