HealthyPhase 1NCT01017666
BIIB014 Effects on the Pharmacokinetics (PK) of Rosiglitazone, Warfarin, and Midazolam
A Phase 1 study testing BIIB014 in people with Healthy, run by Biogen at 1 site in United Kingdom.
Trial summary
The purpose of this study is to understand whether BIIB014 has potential to affect how certain drugs are broken down by the body. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BIIB014
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2009to 2 Jun 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subjects
- Between the ages of 18 and 45, 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 Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Assess the Effect of BIIB014 on the Pharmacokinetics of Rosiglitazone, Warfarin, and Midazolam in Healthy Volunteers
The purpose of this study is to understand whether BIIB014 has potential to affect how certain drugs are broken down by the body.
- Conditions
- Healthy
- Being tested
- BIIB014, Placebo
- Keywords
- Healthy Volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB014Drug
BIIB014 100mg PO Cohort 1 - 8d Cohort 2 - 14d
PlaceboDrug
Matched placebo to BIIB014 Cohort 1 - 8d Cohort 2 - 14d
| Study group | Role | What they receive |
|---|---|---|
| Rosiglitazone 8mg PO | Experimental | Cohort 1 Receives: Drug: BIIB014; Drug: Placebo |
| Midazolam 2mg PO, Warfarin 25mg PO | Experimental | Cohort 2 Receives: Drug: BIIB014; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic profile of rosiglitazone (Cohort 1), midazolam & metabolites and s-warfarin (Cohort 2) during steady state exposure to BIIB014 or placebo
Measured: 24 hours (Cohort 1); 144 hours (Cohort 2)
Secondary outcomes (1)
Adverse Events
Measured: Duration of subject participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2009 (estimated)
- Study start1 Nov 2009
- Primary completion2 Jun 2010
- Study completion2 Jun 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01017666
- Sponsor's protocol ID
- 204HV103
- Other IDs
- EUDRA CT 2009-014259-60
- Status last verified
- Aug 2023
- First submitted
- 16 Nov 2009
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Assess the Effect of BIIB014 on the Pharmacokinetics of Rosiglitazone, Warfarin, and Midazolam in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01017666
- Acronym / sponsor ID
- 204HV103
- Conditions
- Healthy
- Keywords
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2009 (actual)
- Primary completion
- 2 Jun 2010 (actual)
- Study completion
- 2 Jun 2010 (actual)
- First posted
- 20 Nov 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 purpose of this study is to understand whether BIIB014 has potential to affect how certain drugs are broken down by the body.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosiglitazone 8mg PO | Experimental | Drug: BIIB014, Drug: PlaceboCohort 1 |
| Midazolam 2mg PO, Warfarin 25mg PO | Experimental | Drug: BIIB014, Drug: PlaceboCohort 2 |
Who may qualify
- Ages
- 18 to 45 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 45, 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 |
|---|---|---|
| BIIB014BIIB014 100mg PO Cohort 1 - 8d Cohort 2 - 14d | Drug | Midazolam 2mg PO, Warfarin 25mg PO, Rosiglitazone 8mg PO |
| PlaceboMatched placebo to BIIB014 Cohort 1 - 8d Cohort 2 - 14d | Drug | Midazolam 2mg PO, Warfarin 25mg PO, Rosiglitazone 8mg PO |
Primary outcome
Pharmacokinetic profile of rosiglitazone (Cohort 1), midazolam & metabolites and s-warfarin (Cohort 2) during steady state exposure to BIIB014 or placebo
Time frame: 24 hours (Cohort 1); 144 hours (Cohort 2)
1 secondary outcome
Adverse Events
Time frame: Duration of subject participation
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 23 Aug 2023.
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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 in people with Healthy, run by Biogen at 1 site in United Kingdom.
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 23 Aug 2023. 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 Kingdom. 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?
Pharmacokinetic profile of rosiglitazone (Cohort 1), midazolam & metabolites and s-warfarin (Cohort 2) during steady state exposure to BIIB014 or placebo (time frame: 24 hours (Cohort 1); 144 hours (Cohort 2)). 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 23 Aug 2023.