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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 C
Hepatitis, Chronic
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 October 19, 2014