Trigeminal Neuralgia (TN)Phase 1NCT02951221
New Formulation and Food Effect Study of BIIB074
A Phase 1 study testing BIIB074 Treatment A, BIIB074 Treatment B and BIIB074 Treatment C in people with Trigeminal Neuralgia (TN) and Other Neuropathic Pain, run by Biogen at 1 site in United States.
Trial summary
The primary objectives of the study are to assess the relative bioavailability of the BIIB074 direct compression formulation (DCF) to the BIIB074 roller compaction formulation (RCF) and to determine the effect of a high-fat meal on the pharmacokinetics (PK) of the BIIB074 DCF. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Trigeminal Neuralgia (TN), Other Neuropathic Pain
- What is being tested?
- BIIB074 Treatment A, BIIB074 Treatment B and BIIB074 Treatment C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Feb 2017
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must have a body mass index between 18 and 30 kg/m2, inclusive.
- Must be in good health as determined by the Investigator, based on medical history and screening evaluations.
- Ability to consume and tolerate the entire high-fat breakfast within a 30-minute timeframe.
Who cannot join
- History of, or positive test result at Screening for, human immunodeficiency virus (HIV).
- Positive test result at Screening for hepatitis C virus antibody.
- Positive test result at Screening for hepatitis B virus (defined as positive for hepatitis B surface antigen and/or hepatitis B core antibody).
- Previous exposure to BIIB074.
- Consumption of xanthine/caffeine-containing products (e.g., energy drinks, coffee, tea, caffeinated soda) within 48 hours of Day -1 and an unwillingness to refrain from product use during study participation.
- History of alcohol or substance abuse (as determined by the Investigator), a positive urine drug screen or alcohol breath test at Screening or Day -1, or an unwillingness to refrain from alcohol, or illicit or recreational drugs, during the study.
- History or evidence of habitual use of tobacco- or nicotine-containing products within 90 days of Screening, or a positive cotinine screen at Screening or Day -1.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label Study to Evaluate the Relative Bioavailability of Two Formulations of BIIB074 and to Assess the Effect of Food on BIIB074 Pharmacokinetics in Healthy Subjects
The primary objectives of the study are to assess the relative bioavailability of the BIIB074 direct compression formulation (DCF) to the BIIB074 roller compaction formulation (RCF) and to determine the effect of a high-fat meal on the pharmacokinetics (PK) of the BIIB074 DCF. The secondary objective of the study is to assess the safety and tolerability of BIIB074 administered as the DCF following single oral dose administration in healthy participants.
- Conditions
- Trigeminal Neuralgia (TN), Other Neuropathic Pain
- Being tested
- BIIB074 Treatment A, BIIB074 Treatment B, BIIB074 Treatment C, BIIB074 Treatment D
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB074 Treatment ADrug
Lower dose RCF fasted
BIIB074 Treatment BDrug
Lower dose DCF fasted
BIIB074 Treatment CDrug
Higher dose DCF fasted
BIIB074 Treatment DDrug
Higher dose DCF fed
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Treatment sub groups A and B Receives: Drug: BIIB074 Treatment A; Drug: BIIB074 Treatment B |
| Cohort 2 | Experimental | Treatment sub groups C and D Receives: Drug: BIIB074 Treatment C; Drug: BIIB074 Treatment D |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK of BIIB074 DCF to RCF as assessed by maximum observed concentration (Cmax)
Measured: Day 1, 2, 3, 8, 9, 10
PK of BIIB074 DCF to RCF as assessed by area under the concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUClast)
Measured: Day 1, 2, 3, 8, 9, 10
PK of BIIB074 DCF to RCF as assessed by AUC from time 0 to infinity (AUC∞)
Measured: Day 1, 2, 3, 8, 9, 10
PK of BIIB074 DCF as assessed by Cmax
Measured: Day 1, 2, 3, 8, 9, 10
PK of BIIB074 DCF as assessed by AUClast
Measured: Day 1, 2, 3, 8, 9, 10
PK of BIIB074 DCF as assessed by AUC∞
Measured: Day 1, 2, 3, 8, 9, 10
Secondary outcomes (5)
Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Up to Day 18
Number of participants with clinically significant laboratory assessment abnormalities
Measured: Up to Day 10
Number of participants with clinically significant vital sign abnormalities
Measured: Up to Day 10
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
Measured: Up to Day 10
Number of participants with clinically significant physical examinations abnormalities
Measured: Up to Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigeminal Neuralgia (TN)Studies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02951221
- Sponsor's protocol ID
- 802HV107
- Status last verified
- Feb 2017
- First submitted
- 24 Oct 2016
- Last updated
- 27 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study to Evaluate the Relative Bioavailability of Two Formulations of BIIB074 and to Assess the Effect of Food on BIIB074 Pharmacokinetics in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02951221
- Acronym / sponsor ID
- 802HV107
- Conditions
- Trigeminal Neuralgia (TN), Other Neuropathic Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Dec 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 1 Nov 2016 (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 primary objectives of the study are to assess the relative bioavailability of the BIIB074 direct compression formulation (DCF) to the BIIB074 roller compaction formulation (RCF) and to determine the effect of a high-fat meal on the pharmacokinetics (PK) of the BIIB074 DCF. The secondary objective of the study is to assess the safety and tolerability of BIIB074 administered as the DCF following single oral dose administration in healthy participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: BIIB074 Treatment A, Drug: BIIB074 Treatment BTreatment sub groups A and B |
| Cohort 2 | Experimental | Drug: BIIB074 Treatment C, Drug: BIIB074 Treatment DTreatment sub groups C and D |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Must have a body mass index between 18 and 30 kg/m2, inclusive.
- Must be in good health as determined by the Investigator, based on medical history and screening evaluations.
- Ability to consume and tolerate the entire high-fat breakfast within a 30-minute timeframe.
Key exclusion criteria (8 listed)
- History of, or positive test result at Screening for, human immunodeficiency virus (HIV).
- Positive test result at Screening for hepatitis C virus antibody.
- Positive test result at Screening for hepatitis B virus (defined as positive for hepatitis B surface antigen and/or hepatitis B core antibody).
- Previous exposure to BIIB074.
- Consumption of xanthine/caffeine-containing products (e.g., energy drinks, coffee, tea, caffeinated soda) within 48 hours of Day -1 and an unwillingness to refrain from product use during study participation.
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 |
|---|---|---|
| BIIB074 Treatment ALower dose RCF fasted | Drug | Cohort 1 |
| BIIB074 Treatment BLower dose DCF fasted | Drug | Cohort 1 |
| BIIB074 Treatment CHigher dose DCF fasted | Drug | Cohort 2 |
| BIIB074 Treatment DHigher dose DCF fed | Drug | Cohort 2 |
Primary outcome
PK of BIIB074 DCF to RCF as assessed by maximum observed concentration (Cmax)
Time frame: Day 1, 2, 3, 8, 9, 10
PK of BIIB074 DCF to RCF as assessed by area under the concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUClast)
Time frame: Day 1, 2, 3, 8, 9, 10
PK of BIIB074 DCF to RCF as assessed by AUC from time 0 to infinity (AUC∞)
Time frame: Day 1, 2, 3, 8, 9, 10
PK of BIIB074 DCF as assessed by Cmax
Time frame: Day 1, 2, 3, 8, 9, 10
PK of BIIB074 DCF as assessed by AUClast
Time frame: Day 1, 2, 3, 8, 9, 10
PK of BIIB074 DCF as assessed by AUC∞
Time frame: Day 1, 2, 3, 8, 9, 10
5 secondary outcomes
Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to Day 18
Number of participants with clinically significant laboratory assessment abnormalities
Time frame: Up to Day 10
Number of participants with clinically significant vital sign abnormalities
Time frame: Up to Day 10
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
Time frame: Up to Day 10
Number of participants with clinically significant physical examinations abnormalities
Time frame: Up to Day 10
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 27 Feb 2017.
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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.
Medical Director study director
Biogen
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 BIIB074 Treatment A, BIIB074 Treatment B and BIIB074 Treatment C in people with Trigeminal Neuralgia (TN) and Other Neuropathic Pain, 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 8 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 27 Feb 2017. 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?
PK of BIIB074 DCF to RCF as assessed by maximum observed concentration (Cmax) (time frame: Day 1, 2, 3, 8, 9, 10). The study lists 6 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 27 Feb 2017.