HealthyPhase 1NCT01035515
BIIB014 Cardiovascular Monitoring Study
A Phase 1 study testing BIIB014 50mg and BIIB014 100mg in people with Healthy, run by Biogen at 1 site in United States.
Trial summary
The study will examine the effects of a single dose of BIIB014 on blood pressure and haemodynamic variables in healthy volunteers over 24 hours. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BIIB014 50mg and BIIB014 100mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Apr 2010
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subjects
- Between the ages of 18 and 50, inclusive.
- Must have a body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive
Who cannot join
- Clinically significant abnormalities (as determined by the Investigator)
- Other unspecified reason that would make the subject unsuitable for enrollment (as determined by the Investigator)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Randomized, Placebo-Controlled, Double-Blind, Crossover Study to Evaluate the Cardiovascular Effects of Single Doses of Oral BIIB014 in Healthy Volunteers
The study will examine the effects of a single dose of BIIB014 on blood pressure and haemodynamic variables in healthy volunteers over 24 hours.
- Conditions
- Healthy
- Being tested
- Placebo, BIIB014 50mg, BIIB014 100mg
- Keywords
- Healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Single dose oral capsule placebo comparator
BIIB014 50mgDrug
Single dose oral capsule 50mg BIIB014
BIIB014 100mgDrug
Single dose oral capsule 100mg BIIB014
| Study group | Role | What they receive |
|---|---|---|
| Arm One | Experimental | Arm 1 of 6 cross-over arms Receives: Drug: Placebo; Drug: BIIB014 50mg; Drug: BIIB014 100mg |
| Arm Two | Experimental | Arm 2 of 6 cross-over arms Receives: Drug: Placebo; Drug: BIIB014 50mg; Drug: BIIB014 100mg |
| Arm Three | Experimental | Arm 3 of 6 cross-over arms Receives: Drug: Placebo; Drug: BIIB014 50mg; Drug: BIIB014 100mg |
| Arm Four | Experimental | Arm 4 of 6 cross-over arms Receives: Drug: Placebo; Drug: BIIB014 50mg; Drug: BIIB014 100mg |
| Arm Five | Experimental | Arm 5 of 6 cross-over arms Receives: Drug: Placebo; Drug: BIIB014 50mg; Drug: BIIB014 100mg |
| Arm Six | Experimental | Arm 1 of 6 cross-over arms Receives: Drug: Placebo; Drug: BIIB014 50mg; Drug: BIIB014 100mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Supine Blood pressure
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01035515
- Sponsor's protocol ID
- 204HV102
- Status last verified
- Jun 2010
- First submitted
- 17 Dec 2009
- Last updated
- 22 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Placebo-Controlled, Double-Blind, Crossover Study to Evaluate the Cardiovascular Effects of Single Doses of Oral BIIB014 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01035515
- Acronym / sponsor ID
- 204HV102
- Conditions
- Healthy
- Keywords
- Healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 18 Dec 2009 (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 study will examine the effects of a single dose of BIIB014 on blood pressure and haemodynamic variables in healthy volunteers over 24 hours.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm One | Experimental | Drug: Placebo, Drug: BIIB014 50mg, Drug: BIIB014 100mgArm 1 of 6 cross-over arms |
| Arm Two | Experimental | Drug: Placebo, Drug: BIIB014 50mg, Drug: BIIB014 100mgArm 2 of 6 cross-over arms |
| Arm Three | Experimental | Drug: Placebo, Drug: BIIB014 50mg, Drug: BIIB014 100mgArm 3 of 6 cross-over arms |
| Arm Four | Experimental | Drug: Placebo, Drug: BIIB014 50mg, Drug: BIIB014 100mgArm 4 of 6 cross-over arms |
| Arm Five | Experimental | Drug: Placebo, Drug: BIIB014 50mg, Drug: BIIB014 100mgArm 5 of 6 cross-over arms |
| Arm Six | Experimental | Drug: Placebo, Drug: BIIB014 50mg, Drug: BIIB014 100mgArm 1 of 6 cross-over arms |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male or female subjects
- Between the ages of 18 and 50, inclusive.
- Must have a body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive
Key exclusion criteria (2 listed)
- Clinically significant abnormalities (as determined by the Investigator)
- Other unspecified reason that would make the subject unsuitable for enrollment (as determined by the Investigator)
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 |
|---|---|---|
| PlaceboSingle dose oral capsule placebo comparator | Drug | Arm Five, Arm Four, Arm One, Arm Six, Arm Three, Arm Two |
| BIIB014 50mgSingle dose oral capsule 50mg BIIB014 | Drug | Arm Five, Arm Four, Arm One, Arm Six, Arm Three, Arm Two |
| BIIB014 100mgSingle dose oral capsule 100mg BIIB014 | Drug | Arm Five, Arm Four, Arm One, Arm Six, Arm Three, Arm Two |
Primary outcome
Supine Blood pressure
Time frame: 24 hours
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 22 Jun 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 BIIB014 50mg and BIIB014 100mg in people with Healthy, run by Biogen 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 2 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 22 Jun 2010. 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?
Supine Blood pressure (time frame: 24 hours). 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 22 Jun 2010.