Hepatitis CPhase 1NCT01646489
Drug Interaction Study to Assess the Effect of Co-Administered Miravirsen and Telaprevir in Healthy Subjects
A Phase 1 study testing Miravirsen sodium and Telaprevir in people with Hepatitis C and Chronic Hepatitis C, run by Santaris Pharma A/S at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C, Chronic Hepatitis C
- What is being tested?
- Miravirsen sodium and Telaprevir
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Sep 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Current, clinically significant illness or medical condition
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Clinical Research
West Bend, Wisconsin, 53095
About this study
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
The purpose of this study is to assess the safety, tolerability, and affect on blood levels of miravirsen and telaprevir when administered together.
- Conditions
- Hepatitis C, Chronic Hepatitis C
- Being tested
- Miravirsen sodium, Telaprevir
- Keywords
- Antisense, miR-122 antagonist, Safety in healthy volunteers, Hepatitis C
- Medical subject headings
- Hepatitis C, Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Miravirsen sodiumDrug
Also called Miravirsen, SPC3649
Miravirsen 7 mg/kg to be administered as single subcutaneous injections for a total of 5 doses over a 5 week treatment period.
TelaprevirDrug
Also called Incivek
Telaprevir 750 mg to be administered as single and multiple oral doses over two 7 day treatment periods.
| Study group | Role | What they receive |
|---|---|---|
| Miravirsen sodium | Experimental | Not described Receives: Drug: Miravirsen sodium |
| Telaprevir | Active comparator | Not described Receives: Drug: Telaprevir |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of miravirsen on telaprevir pharmacokinetics as determined by AUC0-24h, Cmax and tmax.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (1)
The effect of telaprevir on miravirsen pharmacokinetics as determined by AUC0-24h, Cmax and tmax.
Measured: Up to 24 hours after dosing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santaris Pharma A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Rice, MD, Principal investigator, Spaulding Clinical Research LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01646489
- Sponsor's protocol ID
- SPC3649-206
- Status last verified
- Nov 2012
- First submitted
- 4 Jul 2012
- Last updated
- 12 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01646489
- Acronym / sponsor ID
- SPC3649-206
- Conditions
- Hepatitis C, Chronic Hepatitis C
- Keywords
- Antisense, miR-122 antagonist, Safety in healthy volunteers, Hepatitis C
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Santaris Pharma A/SIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 20 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety, tolerability, and affect on blood levels of miravirsen and telaprevir when administered together.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Miravirsen sodium | Experimental | Drug: Miravirsen sodium |
| Telaprevir | Active comparator | Drug: Telaprevir |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Current, clinically significant illness or medical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Miravirsen sodiumAlso: Miravirsen, SPC3649Miravirsen 7 mg/kg to be administered as single subcutaneous injections for a total of 5 doses over a 5 week treatment period. | Drug | Miravirsen sodium |
| TelaprevirAlso: IncivekTelaprevir 750 mg to be administered as single and multiple oral doses over two 7 day treatment periods. | Drug | Telaprevir |
Primary outcome
The effect of miravirsen on telaprevir pharmacokinetics as determined by AUC0-24h, Cmax and tmax.
Time frame: Up to 24 hours after dosing.
Safety and tolerability of co-administered miravirsen and telaprevir.
Time frame: 12 weeks
Safety and tolerability will be assessed by evaluation of adverse events, physical examinations, vital signs, clinical safety laboratory assessments and electrocardiograms.
1 secondary outcome
The effect of telaprevir on miravirsen pharmacokinetics as determined by AUC0-24h, Cmax and tmax.
Time frame: Up to 24 hours after dosing.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Rice, MD principal investigator
Spaulding Clinical Research LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Miravirsen sodium and Telaprevir in people with Hepatitis C and Chronic Hepatitis C, run by Santaris Pharma A/S at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of miravirsen on telaprevir pharmacokinetics as determined by AUC0-24h, Cmax and tmax. (time frame: Up to 24 hours after dosing.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2012.