HealthyPhase 1NCT02831517
PK and Safety Study of BIIB074 in Healthy Japanese and Caucasian Participants
A Phase 1 study testing BIIB074 in people with Healthy and Trigeminal Neuralgia, run by Biogen at 1 site in United Kingdom.
Trial summary
The primary objectives of this study are: To evaluate pharmacokinetics (PK) properties of BIIB074 administered as a single oral dose in healthy Japanese and Caucasian participants; and To evaluate the PK properties of BIIB074 administered as repeated oral doses in healthy Japanese participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Trigeminal Neuralgia
- What is being tested?
- BIIB074
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 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
- Japanese or Caucasian.
- Japanese participants must have been born in Japan, and their biological parents and grandparents must all have been of Japanese origin.
- Must have a body mass index between 18 and 30 kg/m2, inclusive.
Who cannot join
- Previous exposure to BIIB074, with the exception that Japanese participants who complete Part 1.
- Use of any oral, injected, or implanted hormonal method of contraception that contains ethinyl estradiol within 28 days of Day -1 and an unwillingness to refrain from product use during study participation.
- 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 Pharmacokinetics and Safety Study of BIIB074 in Healthy Japanese and Caucasian Subjects
The primary objectives of this study are: To evaluate pharmacokinetics (PK) properties of BIIB074 administered as a single oral dose in healthy Japanese and Caucasian participants; and To evaluate the PK properties of BIIB074 administered as repeated oral doses in healthy Japanese participants. The secondary objective of this study is to assess the safety and tolerability of BIIB074 administered as a single oral dose (Japanese and Caucasian participants) and as repeated oral doses (Japanese participants).
- Conditions
- Healthy, Trigeminal Neuralgia
- Being tested
- BIIB074, Placebo
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB074Drug
Also called CNV1014802
Administered as specified in the treatment arm
PlaceboDrug
Matched Placebo
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | 48 participants: Cohorts 1,2 and 3 (Single Ascending Dose of BIIB074 or placebo) in a 6:2 ratio Receives: Drug: BIIB074; Drug: Placebo |
| Part 2 | Experimental | 16 participants: Multiple Ascending Dosing of BIIB074 or placebo in a 6:2 ratio; 3 times daily [TID] in cohort 4 for 6 days and one time (QD) for 1 day and 2 times daily [BID] in cohort 5 for 6 days and QD for 1 day Receives: Drug: BIIB074; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: PK of BIIB074 single oral dose as assessed by maximum observed concentration (Cmax )
Measured: 15 minutes prior to dosing up to 96 hours post dose
Part 1: PK of BIIB074 single oral dose as assessed by time to reach Cmax (tmax)
Measured: 15 minutes prior to dosing up to 96 hours post dose
Part 1: PK of BIIB074 single oral dose as assessed by area under the concentration time curve from time 0 extrapolated to infinity (AUCinf)
Measured: 15 minutes prior to dosing up to 96 hours post dose
Part 1: PK of BIIB074 single oral dose as assessed by area under the concentration time curve from time 0 to time of the last measurable drug concentration (AUC0-t)
Measured: 15 minutes prior to dosing up to 96 hours post dose
Part 1: PK of BIIB074 single oral dose as assessed by terminal elimination half-life (t1/2)
Measured: 15 minutes prior to dosing up to 96 hours post dose
Part 1: PK of BIIB074 single oral dose as assessed by apparent volume of distribution (Vd/F)
Measured: 15 minutes prior to dosing up to 96 hours post dose
Part 1: PK of BIIB074 single oral dose as assessed by apparent total body clearance (CL/F)
Measured: 15 minutes prior to dosing up to 96 hours post dose
Part 1: PK of BIIB074 single oral dose as assessed by metabolite to parent ratio in AUC (MRAUC)
Measured: 15 minutes prior to dosing up to 96 hours post dose
Part 2: PK of BIIB074 repeated oral dose as assessed by Cmax
Measured: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Part 2: PK of BIIB074 repeated oral dose as assessed by tmax
Measured: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Part 2: PK of BIIB074 repeated oral dose as assessed by area under the concentration time curve within a dosing interval (AUCtau)
Measured: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Part 2: PK of BIIB074 repeated oral dose as assessed by trough concentration after repeated doses (Ctrough)
Measured: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Part 2: PK of BIIB074 repeated oral dose as assessed by t1/2
Measured: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Part 2: PK of BIIB074 repeated oral dose as assessed by apparent volume of distribution at steady state (Vss/F)
Measured: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Part 2: PK of BIIB074 repeated oral dose as assessed by apparent clearance at steady state (CLss/F)
Measured: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Part 2: PK of BIIB074 repeated oral dose as assessed by accumulation ratio (Rac)
Measured: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Part 2: PK of BIIB074 repeated oral dose as assessed by MRAUC
Measured: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Secondary outcomes (5)
Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Up to 2 weeks post Part 2 of the Treatment Period
Number of participants with clinically significant laboratory assessment abnormalities
Measured: Up to 2 weeks post Part 2 of the Treatment Period
Number of participants with clinically significant vital sign abnormalities
Measured: Up to 2 weeks post Part 2 of the Treatment Period
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
Measured: Up to 2 weeks post Part 2 of the Treatment Period
Number of participants with clinically significant physical examinations abnormalities
Measured: Up to 2 weeks post Part 2 of the Treatment Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study startAug 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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 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
- NCT02831517
- Sponsor's protocol ID
- 802HV106
- Other IDs
- 2016-000874-39, 2016
- Status last verified
- Mar 2017
- First submitted
- 11 Jul 2016
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Pharmacokinetics and Safety Study of BIIB074 in Healthy Japanese and Caucasian Subjects
- ClinicalTrials.gov ID
- NCT02831517
- Acronym / sponsor ID
- 802HV106
- Conditions
- Healthy, Trigeminal Neuralgia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 13 Jul 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 this study are: To evaluate pharmacokinetics (PK) properties of BIIB074 administered as a single oral dose in healthy Japanese and Caucasian participants; and To evaluate the PK properties of BIIB074 administered as repeated oral doses in healthy Japanese participants. The secondary objective of this study is to assess the safety and tolerability of BIIB074 administered as a single oral dose (Japanese and Caucasian participants) and as repeated oral doses (Japanese participants).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: BIIB074, Drug: Placebo48 participants: Cohorts 1,2 and 3 (Single Ascending Dose of BIIB074 or placebo) in a 6:2 ratio |
| Part 2 | Experimental | Drug: BIIB074, Drug: Placebo16 participants: Multiple Ascending Dosing of BIIB074 or placebo in a 6:2 ratio; 3 times daily [TID] in cohort 4 for 6 days and one time (QD) for 1 day and 2 times daily [BID] in cohort 5 for 6 days and QD for 1 day |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Japanese or Caucasian.
- Japanese participants must have been born in Japan, and their biological parents and grandparents must all have been of Japanese origin.
- Must have a body mass index between 18 and 30 kg/m2, inclusive.
Key exclusion criteria (3 listed)
- Previous exposure to BIIB074, with the exception that Japanese participants who complete Part 1.
- Use of any oral, injected, or implanted hormonal method of contraception that contains ethinyl estradiol within 28 days of Day -1 and an unwillingness to refrain from product use during study participation.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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 |
|---|---|---|
| BIIB074Also: CNV1014802Administered as specified in the treatment arm | Drug | Part 1, Part 2 |
| PlaceboMatched Placebo | Drug | Part 1, Part 2 |
Primary outcome
Part 1: PK of BIIB074 single oral dose as assessed by maximum observed concentration (Cmax )
Time frame: 15 minutes prior to dosing up to 96 hours post dose
Part 1: PK of BIIB074 single oral dose as assessed by time to reach Cmax (tmax)
Time frame: 15 minutes prior to dosing up to 96 hours post dose
Part 1: PK of BIIB074 single oral dose as assessed by area under the concentration time curve from time 0 extrapolated to infinity (AUCinf)
Time frame: 15 minutes prior to dosing up to 96 hours post dose
Part 1: PK of BIIB074 single oral dose as assessed by area under the concentration time curve from time 0 to time of the last measurable drug concentration (AUC0-t)
Time frame: 15 minutes prior to dosing up to 96 hours post dose
Part 1: PK of BIIB074 single oral dose as assessed by terminal elimination half-life (t1/2)
Time frame: 15 minutes prior to dosing up to 96 hours post dose
Part 1: PK of BIIB074 single oral dose as assessed by apparent volume of distribution (Vd/F)
Time frame: 15 minutes prior to dosing up to 96 hours post dose
Part 1: PK of BIIB074 single oral dose as assessed by apparent total body clearance (CL/F)
Time frame: 15 minutes prior to dosing up to 96 hours post dose
Part 1: PK of BIIB074 single oral dose as assessed by metabolite to parent ratio in AUC (MRAUC)
Time frame: 15 minutes prior to dosing up to 96 hours post dose
Part 2: PK of BIIB074 repeated oral dose as assessed by Cmax
Time frame: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Part 2: PK of BIIB074 repeated oral dose as assessed by tmax
Time frame: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Part 2: PK of BIIB074 repeated oral dose as assessed by area under the concentration time curve within a dosing interval (AUCtau)
Time frame: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Part 2: PK of BIIB074 repeated oral dose as assessed by trough concentration after repeated doses (Ctrough)
Time frame: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Part 2: PK of BIIB074 repeated oral dose as assessed by t1/2
Time frame: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Part 2: PK of BIIB074 repeated oral dose as assessed by apparent volume of distribution at steady state (Vss/F)
Time frame: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Part 2: PK of BIIB074 repeated oral dose as assessed by apparent clearance at steady state (CLss/F)
Time frame: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Part 2: PK of BIIB074 repeated oral dose as assessed by accumulation ratio (Rac)
Time frame: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Part 2: PK of BIIB074 repeated oral dose as assessed by MRAUC
Time frame: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
5 secondary outcomes
Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 2 weeks post Part 2 of the Treatment Period
Number of participants with clinically significant laboratory assessment abnormalities
Time frame: Up to 2 weeks post Part 2 of the Treatment Period
Number of participants with clinically significant vital sign abnormalities
Time frame: Up to 2 weeks post Part 2 of the Treatment Period
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
Time frame: Up to 2 weeks post Part 2 of the Treatment Period
Number of participants with clinically significant physical examinations abnormalities
Time frame: Up to 2 weeks post Part 2 of the Treatment Period
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 9 Mar 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 in people with Healthy and Trigeminal Neuralgia, 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 3 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 9 Mar 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 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?
Part 1: PK of BIIB074 single oral dose as assessed by maximum observed concentration (Cmax ) (time frame: 15 minutes prior to dosing up to 96 hours post dose). The study lists 17 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 9 Mar 2017.