Drug Interaction Study to Assess the Effect of Co-Administered Miravirsen and Telaprevir in Healthy Subjects
A Phase 1, Open-Label, Drug Interaction Study to Assess Safety, Tolerability, and Pharmacokinetics of Co-Administered Miravirsen and Telaprevir in Healthy Subjects
1 other identifier
interventional
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2012
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 4, 2012
CompletedFirst Posted
Study publicly available on registry
July 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedNovember 12, 2012
November 1, 2012
3 months
July 4, 2012
November 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The effect of miravirsen on telaprevir pharmacokinetics as determined by AUC0-24h, Cmax and tmax.
Up to 24 hours after dosing.
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.
12 weeks
Secondary Outcomes (1)
The effect of telaprevir on miravirsen pharmacokinetics as determined by AUC0-24h, Cmax and tmax.
Up to 24 hours after dosing.
Study Arms (2)
Miravirsen sodium
EXPERIMENTALTelaprevir
ACTIVE COMPARATORInterventions
Miravirsen 7 mg/kg to be administered as single subcutaneous injections for a total of 5 doses over a 5 week treatment period.
Telaprevir 750 mg to be administered as single and multiple oral doses over two 7 day treatment periods.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Current, clinically significant illness or medical condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Spaulding Clinical Research
West Bend, Wisconsin, 53095, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Rice, MD
Spaulding Clinical Research LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 4, 2012
First Posted
July 20, 2012
Study Start
June 1, 2012
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
November 12, 2012
Record last verified: 2012-11