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NCT Number: NCT01646489

Drug Interaction Study to Assess the Effect 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.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Chronic Disease Chronic Hepatitis C Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Spaulding Clinical Research

West Bend, Wisconsin, 53095, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Miravirsen sodium

Drug

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: Miravirsen, SPC3649

Telaprevir

Drug

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

Other names: Incivek

Primary outcomes

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

    Time frame: Up to 24 hours after dosing.

  2. 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.

Secondary outcomes

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

    Time frame: Up to 24 hours after dosing.

Sponsors and collaborators

Lead sponsor

Santaris Pharma A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 20, 2012
Registry last updated
Nov 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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