Chronic Hepatitis C, Hepatitis C
Conditions
Keywords
Antisense, miR-122 antagonist, Safety in healthy volunteers, Hepatitis C
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.
Interventions
Miravirsen 7 mg/kg to be administered as single subcutaneous injections for a total of 5 doses over a 5 week treatment period.
DRUGTelaprevir
Telaprevir 750 mg to be administered as single and multiple oral doses over two 7 day treatment periods.
Sponsors
Santaris Pharma A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 12 weeks | Safety and tolerability will be assessed by evaluation of adverse events, physical examinations, vital signs, clinical safety laboratory assessments and electrocardiograms. |
Secondary
| Measure | Time frame |
|---|---|
| The effect of telaprevir on miravirsen pharmacokinetics as determined by AUC0-24h, Cmax and tmax. | Up to 24 hours after dosing. |
Countries
United States
Outcome results
None listed