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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Santaris Pharma A/S
ClinicalTrials.gov Identifier:
NCT01646489
First received: July 4, 2012
Last updated: November 9, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention Phase
Hepatitis C
Chronic Hepatitis C
Drug: Miravirsen sodium
Drug: Telaprevir
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Drug Interaction Study to Assess Safety, Tolerability, and Pharmacokinetics of Co-Administered Miravirsen and Telaprevir in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Santaris Pharma A/S:

Primary Outcome Measures:
  • The effect of miravirsen on telaprevir pharmacokinetics as determined by AUC0-24h, Cmax and tmax. [ Time Frame: Up to 24 hours after dosing. ] [ Designated as safety issue: No ]
  • Safety and tolerability of co-administered miravirsen and telaprevir. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Safety and tolerability will be assessed by evaluation of adverse events, physical examinations, vital signs, clinical safety laboratory assessments and electrocardiograms.


Secondary Outcome Measures:
  • The effect of telaprevir on miravirsen pharmacokinetics as determined by AUC0-24h, Cmax and tmax. [ Time Frame: Up to 24 hours after dosing. ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: June 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Miravirsen
  • Miravirsen sodium
  • SPC3649
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:
  • Telaprevir
  • Incivek

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01646489

Locations
United States, Wisconsin
Spaulding Clinical Research
West Bend, Wisconsin, United States, 53095
Sponsors and Collaborators
Santaris Pharma A/S
Investigators
Principal Investigator: Paul Rice, MD Spaulding Clinical Research
  More Information

No publications provided

Responsible Party: Santaris Pharma A/S
ClinicalTrials.gov Identifier: NCT01646489     History of Changes
Other Study ID Numbers: SPC3649-206
Study First Received: July 4, 2012
Last Updated: November 9, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Santaris Pharma A/S:
Antisense
miR-122 antagonist
Safety in healthy volunteers
Hepatitis C

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on April 17, 2014