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

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01646489
• Other study ID #: SPC3649-206
• Status: Completed
• Phase: Phase 1
• First received: July 4, 2012
• Last updated: November 9, 2012
• Start date: June 2012
• Est. completion date: September 2012

Study information

• Verified date: November 2012
• Source: Santaris Pharma A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

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

Locations

Country	Name	City	State
United States	Spaulding Clinical Research	West Bend	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Santaris Pharma A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of miravirsen on telaprevir pharmacokinetics as determined by AUC0-24h, Cmax and tmax.		Up to 24 hours after dosing.	No
Primary	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	Yes
Secondary	The effect of telaprevir on miravirsen pharmacokinetics as determined by AUC0-24h, Cmax and tmax.		Up to 24 hours after dosing.	No