Back to resultsDrug Interaction Study to Assess the Effect of Co-Administered Miravirsen and Telaprevir in Healthy Subjects
Primary Purpose
Hepatitis C, Chronic Hepatitis C
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Miravirsen sodium
Telaprevir
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring Antisense, miR-122 antagonist, Safety in healthy volunteers, Hepatitis C
Eligibility 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
Sites / Locations
- Spaulding Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Miravirsen sodium
Telaprevir
Arm Description
Outcomes
Primary Outcome Measures
The effect of miravirsen on telaprevir pharmacokinetics as determined by AUC0-24h, Cmax and tmax.
Safety and tolerability of co-administered miravirsen and telaprevir.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01646489
Brief Title
Drug Interaction Study to Assess the Effect of Co-Administered Miravirsen and Telaprevir in Healthy Subjects
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santaris Pharma A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the safety, tolerability, and affect on blood levels of miravirsen and telaprevir when administered together.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic Hepatitis C
Keywords
Antisense, miR-122 antagonist, Safety in healthy volunteers, Hepatitis C
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Miravirsen sodium
Arm Type
Experimental
Arm Title
Telaprevir
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Miravirsen sodium
Other Intervention Name(s)
Miravirsen, SPC3649
Intervention Description
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
Intervention Name(s)
Telaprevir
Other Intervention Name(s)
Incivek
Intervention Description
Telaprevir 750 mg to be administered as single and multiple oral doses over two 7 day treatment periods.
Primary Outcome Measure Information:
Title
The effect of miravirsen on telaprevir pharmacokinetics as determined by AUC0-24h, Cmax and tmax.
Time Frame
Up to 24 hours after dosing.
Title
Safety and tolerability of co-administered miravirsen and telaprevir.
Description
Safety and tolerability will be assessed by evaluation of adverse events, physical examinations, vital signs, clinical safety laboratory assessments and electrocardiograms.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
The effect of telaprevir on miravirsen pharmacokinetics as determined by AUC0-24h, Cmax and tmax.
Time Frame
Up to 24 hours after dosing.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Rice, MD
Organizational Affiliation
Spaulding Clinical Research LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spaulding Clinical Research
City
West Bend
State/Province
Wisconsin
ZIP/Postal Code
53095
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Drug Interaction Study to Assess the Effect of Co-Administered Miravirsen and Telaprevir in Healthy Subjects
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