Healthy VolunteersPhase 1NCT04106050
Pharmacodynamic Study of BIIB095 and BIIB074 in Healthy Participants and Participants With Painful Diabetic Polyneuropathy
A Phase 1 study testing BIIB095, BIIB074 and Lidocaine in people with Healthy Volunteers and Diabetic Neuropathies, run by Biogen.
Trial summary
Part A: Primary objective is to determine the effects of BIIB095 on nerve excitability in healthy participants. Secondary and exploratory objectives include determining the effects of BIIB095 on nerve excitability in diabetic polyneuropathy (DPN) and assessing the safety, tolerability and pharmacokinetics of BIIB095. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Diabetic Neuropathies
- What is being tested?
- BIIB095, BIIB074 and Lidocaine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2020to 21 Jan 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy participants must be in good health, as determined based on medical history and screening evaluations
- Participants with DPN
- Must have a documented diagnosis of type 2 diabetes mellitus (DM)
- Must have stable glycemic control
- Must have at least clinical evidence of painful DPN
- Pain related to DPN must be present for at least 6 months prior to screening
- Average daily pain intensity over 7 consecutive days recorded during screening must be ≥ 4 on an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain imaginable)
Who cannot join
- Any neurologic or painful condition that could confound the interpretation of study results
- History of any clinically significant cardiac, hematologic, hepatic, immunologic, urologic, pulmonary, dermatologic, psychiatric, renal, or other major disease. This includes any clinically significant endocrinologic or neurologic disease other than DM or DPN.
- Use of local anesthetics or capsaicin for topical or regional treatment within 3 months prior to Screening.
- Systemic use of sodium channel inhibitors
- Note: Other protocol-specific inclusion/exclusion criteria may apply.
About this study
Official title: A Phase 1b, Randomized, Double-Blind, Parallel, Placebo- and Active-Controlled, Pharmacodynamic Study of BIIB095 and BIIB074 in Healthy Participants and Participants With Painful Diabetic Polyneuropathy
Part A: Primary objective is to determine the effects of BIIB095 on nerve excitability in healthy participants. Secondary and exploratory objectives include determining the effects of BIIB095 on nerve excitability in diabetic polyneuropathy (DPN) and assessing the safety, tolerability and pharmacokinetics of BIIB095.
Part B (optional): Equivalent objectives are pursued for BIIB074.
- Conditions
- Healthy Volunteers, Diabetic Neuropathies
- Being tested
- BIIB095, BIIB074, Placebo, Lidocaine
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB095Drug
Administered as specified in the treatment arm.
BIIB074Drug
Administered as specified in the treatment arm.
PlaceboDrug
Administered as specified in the treatment arm.
LidocaineDrug
Administered as specified in the treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| Part A: BIIB095 Dose 1 | Experimental | Healthy participants and participants with DPN will receive oral dose of BIIB095 Dose 1 capsules from Day 1 to Day 8. Receives: Drug: BIIB095 |
| Part A: BIIB095 Dose 2 | Experimental | Healthy participants and participants with DPN will receive oral dose of BIIB095 Dose 2 capsules from Day 1 to Day 8. Receives: Drug: BIIB095 |
| Part A: BIIB095 Dose 3 | Experimental | Healthy participants and participants with DPN will receive oral dose of BIIB095 Dose 3 capsules from Day 1 to Day 8. Receives: Drug: BIIB095 |
| Part A: BIIB095 Placebo | Placebo comparator | Healthy participants and participants with DPN will receive oral dose of placebo matching BIIB095 capsules from Day 1 to Day 8. Receives: Drug: Placebo |
| Part A: Lidocaine | Active comparator | Healthy participants and participants with DPN will receive single injection of lidocaine for partial nerve conduction block and single injection of lidocaine for skin infiltration on Day 8. Receives: Drug: Lidocaine |
| Part B: BIIB074 Dose 1 | Experimental | Healthy participants and participants with DPN will receive oral dose of BIIB074 Dose 1 tablets from Day 1 to Day 8. Receives: Drug: BIIB074 |
| Part B: BIIB074 Placebo | Placebo comparator | Healthy participants and participants with DPN will receive oral dose of placebo matching BIIB074 tablets from Day 1 to Day 8. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Nerve Excitability from Baseline (Day 1) to Last Treatment Visit (Day 8) as Determined by Compound Muscle Action Potential Threshold Tracking (CMAP-TT) in the Median Nerve of Healthy Participants
Measured: Baseline (Day 1), Day 8
Secondary outcomes (7)
Change in Sensory Nerve Excitability from Baseline (Day 1) to Last Treatment Visit (Day 8) as Determined by Sensory Nerve Action Potential Threshold Tracking (SNAP-TT) in the Median Nerve of Healthy Participants
Measured: Baseline (Day 1), Day 8
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: AEs: Day 1 up to Day 22; SAEs: Screening up to Day 22
Area Under the Curve from Time Zero to Time of the Last Measurable Concentration (AUClast)
Measured: Pre-dose, 1 hour (h), 1.5h, 3h, 6h and 8h post-dose on Day 8
Area Under the Curve within a Dosing Interval (AUCtau)
Measured: Pre-dose, 1 hour (h), 1.5h, 3h, 6h and 8h post-dose on Day 8
Maximum Observed Concentration (Cmax)
Measured: Pre-dose, 1 hour (h), 1.5h, 3h, 6h and 8h post-dose on Day 8
Trough Concentration (Ctrough)
Measured: Pre-dose, 1 hour (h), 1.5h, 3h, 6h and 8h post-dose on Day 8
Time to Reach Maximum Observed Concentration (Tmax)
Measured: Pre-dose, 1 hour (h), 1.5h, 3h, 6h and 8h post-dose on Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start30 Sep 2020 (estimated)
- Primary completion21 Jan 2022 (estimated)
- Study completion21 Jan 2022 (estimated)
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 0 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
- NCT04106050
- Sponsor's protocol ID
- 255NP101
- Other IDs
- 2019-001900-39, 2019
- Status last verified
- Mar 2021
- First submitted
- 25 Sep 2019
- Last updated
- 22 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Randomized, Double-Blind, Parallel, Placebo- and Active-Controlled, Pharmacodynamic Study of BIIB095 and BIIB074 in Healthy Participants and Participants With Painful Diabetic Polyneuropathy
- ClinicalTrials.gov ID
- NCT04106050
- Acronym / sponsor ID
- 255NP101
- Conditions
- Healthy Volunteers, Diabetic Neuropathies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2020 (estimated)
- Primary completion
- 21 Jan 2022 (estimated)
- Study completion
- 21 Jan 2022 (estimated)
- First posted
- 26 Sep 2019 (actual)
- 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.
Part A: Primary objective is to determine the effects of BIIB095 on nerve excitability in healthy participants. Secondary and exploratory objectives include determining the effects of BIIB095 on nerve excitability in diabetic polyneuropathy (DPN) and assessing the safety, tolerability and pharmacokinetics of BIIB095.
Part B (optional): Equivalent objectives are pursued for BIIB074.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Part A: BIIB095 Dose 1 | Experimental | Drug: BIIB095Healthy participants and participants with DPN will receive oral dose of BIIB095 Dose 1 capsules from Day 1 to Day 8. |
| Part A: BIIB095 Dose 2 | Experimental | Drug: BIIB095Healthy participants and participants with DPN will receive oral dose of BIIB095 Dose 2 capsules from Day 1 to Day 8. |
| Part A: BIIB095 Dose 3 | Experimental | Drug: BIIB095Healthy participants and participants with DPN will receive oral dose of BIIB095 Dose 3 capsules from Day 1 to Day 8. |
| Part A: BIIB095 Placebo | Placebo comparator | Drug: PlaceboHealthy participants and participants with DPN will receive oral dose of placebo matching BIIB095 capsules from Day 1 to Day 8. |
| Part A: Lidocaine | Active comparator | Drug: LidocaineHealthy participants and participants with DPN will receive single injection of lidocaine for partial nerve conduction block and single injection of lidocaine for skin infiltration on Day 8. |
| Part B: BIIB074 Dose 1 | Experimental | Drug: BIIB074Healthy participants and participants with DPN will receive oral dose of BIIB074 Dose 1 tablets from Day 1 to Day 8. |
| Part B: BIIB074 Placebo | Placebo comparator | Drug: PlaceboHealthy participants and participants with DPN will receive oral dose of placebo matching BIIB074 tablets from Day 1 to Day 8. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy participants must be in good health, as determined based on medical history and screening evaluations
- Participants with DPN
Key exclusion criteria (5 listed)
- Any neurologic or painful condition that could confound the interpretation of study results
- History of any clinically significant cardiac, hematologic, hepatic, immunologic, urologic, pulmonary, dermatologic, psychiatric, renal, or other major disease. This includes any clinically significant endocrinologic or neurologic disease other than DM or DPN.
- Use of local anesthetics or capsaicin for topical or regional treatment within 3 months prior to Screening.
- Systemic use of sodium channel inhibitors
- Note: Other protocol-specific 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 |
|---|---|---|
| BIIB095Administered as specified in the treatment arm. | Drug | Part A: BIIB095 Dose 1, Part A: BIIB095 Dose 2, Part A: BIIB095 Dose 3 |
| BIIB074Administered as specified in the treatment arm. | Drug | Part B: BIIB074 Dose 1 |
| PlaceboAdministered as specified in the treatment arm. | Drug | Part A: BIIB095 Placebo, Part B: BIIB074 Placebo |
| LidocaineAdministered as specified in the treatment arm. | Drug | Part A: Lidocaine |
Primary outcome
Change in Nerve Excitability from Baseline (Day 1) to Last Treatment Visit (Day 8) as Determined by Compound Muscle Action Potential Threshold Tracking (CMAP-TT) in the Median Nerve of Healthy Participants
Time frame: Baseline (Day 1), Day 8
7 secondary outcomes
Change in Sensory Nerve Excitability from Baseline (Day 1) to Last Treatment Visit (Day 8) as Determined by Sensory Nerve Action Potential Threshold Tracking (SNAP-TT) in the Median Nerve of Healthy Participants
Time frame: Baseline (Day 1), Day 8
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: AEs: Day 1 up to Day 22; SAEs: Screening up to Day 22
Area Under the Curve from Time Zero to Time of the Last Measurable Concentration (AUClast)
Time frame: Pre-dose, 1 hour (h), 1.5h, 3h, 6h and 8h post-dose on Day 8
Area Under the Curve within a Dosing Interval (AUCtau)
Time frame: Pre-dose, 1 hour (h), 1.5h, 3h, 6h and 8h post-dose on Day 8
Maximum Observed Concentration (Cmax)
Time frame: Pre-dose, 1 hour (h), 1.5h, 3h, 6h and 8h post-dose on Day 8
Trough Concentration (Ctrough)
Time frame: Pre-dose, 1 hour (h), 1.5h, 3h, 6h and 8h post-dose on Day 8
Time to Reach Maximum Observed Concentration (Tmax)
Time frame: Pre-dose, 1 hour (h), 1.5h, 3h, 6h and 8h post-dose on Day 8
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/
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Screening Protocol
Pain
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
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BIIB095, BIIB074 and Lidocaine in people with Healthy Volunteers and Diabetic Neuropathies, run by Biogen.
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 7 inclusion and 5 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: withdrawn, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in Nerve Excitability from Baseline (Day 1) to Last Treatment Visit (Day 8) as Determined by Compound Muscle Action Potential Threshold Tracking (CMAP-TT) in the Median Nerve of Healthy Participants (time frame: Baseline (Day 1), Day 8). 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 Mar 2021.