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Pharmacodynamic Study of BIIB095 and BIIB074 in Healthy Participants and Participants With Painful Diabetic Polyneuropathy

Primary Purpose

Healthy Volunteers, Diabetic Neuropathies

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
BIIB095
BIIB074
Placebo
Lidocaine
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy Volunteers

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Key Inclusion Criteria:

  • 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)

Key Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm Type

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Active Comparator

    Experimental

    Placebo Comparator

    Arm Label

    Part A: BIIB095 Dose 1

    Part A: BIIB095 Dose 2

    Part A: BIIB095 Dose 3

    Part A: BIIB095 Placebo

    Part A: Lidocaine

    Part B: BIIB074 Dose 1

    Part B: BIIB074 Placebo

    Arm Description

    Healthy participants and participants with DPN will receive oral dose of BIIB095 Dose 1 capsules from Day 1 to Day 8.

    Healthy participants and participants with DPN will receive oral dose of BIIB095 Dose 2 capsules from Day 1 to Day 8.

    Healthy participants and participants with DPN will receive oral dose of BIIB095 Dose 3 capsules from Day 1 to Day 8.

    Healthy participants and participants with DPN will receive oral dose of placebo matching BIIB095 capsules from Day 1 to Day 8.

    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.

    Healthy participants and participants with DPN will receive oral dose of BIIB074 Dose 1 tablets from Day 1 to Day 8.

    Healthy participants and participants with DPN will receive oral dose of placebo matching BIIB074 tablets from Day 1 to Day 8.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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
    Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
    Area Under the Curve from Time Zero to Time of the Last Measurable Concentration (AUClast)
    Area Under the Curve within a Dosing Interval (AUCtau)
    Maximum Observed Concentration (Cmax)
    Trough Concentration (Ctrough)
    Time to Reach Maximum Observed Concentration (Tmax)

    Full Information

    First Posted
    September 25, 2019
    Last Updated
    March 19, 2021
    Sponsor
    Biogen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04106050
    Brief Title
    Pharmacodynamic Study of BIIB095 and BIIB074 in Healthy Participants and Participants With Painful Diabetic Polyneuropathy
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Sponsor Decision
    Study Start Date
    September 30, 2020 (Anticipated)
    Primary Completion Date
    January 21, 2022 (Anticipated)
    Study Completion Date
    January 21, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Biogen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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. Part B (optional): Equivalent objectives are pursued for BIIB074.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Healthy Volunteers, Diabetic Neuropathies

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Part A: BIIB095 Dose 1
    Arm Type
    Experimental
    Arm Description
    Healthy participants and participants with DPN will receive oral dose of BIIB095 Dose 1 capsules from Day 1 to Day 8.
    Arm Title
    Part A: BIIB095 Dose 2
    Arm Type
    Experimental
    Arm Description
    Healthy participants and participants with DPN will receive oral dose of BIIB095 Dose 2 capsules from Day 1 to Day 8.
    Arm Title
    Part A: BIIB095 Dose 3
    Arm Type
    Experimental
    Arm Description
    Healthy participants and participants with DPN will receive oral dose of BIIB095 Dose 3 capsules from Day 1 to Day 8.
    Arm Title
    Part A: BIIB095 Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Healthy participants and participants with DPN will receive oral dose of placebo matching BIIB095 capsules from Day 1 to Day 8.
    Arm Title
    Part A: Lidocaine
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Part B: BIIB074 Dose 1
    Arm Type
    Experimental
    Arm Description
    Healthy participants and participants with DPN will receive oral dose of BIIB074 Dose 1 tablets from Day 1 to Day 8.
    Arm Title
    Part B: BIIB074 Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Healthy participants and participants with DPN will receive oral dose of placebo matching BIIB074 tablets from Day 1 to Day 8.
    Intervention Type
    Drug
    Intervention Name(s)
    BIIB095
    Intervention Description
    Administered as specified in the treatment arm.
    Intervention Type
    Drug
    Intervention Name(s)
    BIIB074
    Intervention Description
    Administered as specified in the treatment arm.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Administered as specified in the treatment arm.
    Intervention Type
    Drug
    Intervention Name(s)
    Lidocaine
    Intervention Description
    Administered as specified in the treatment arm.
    Primary Outcome Measure Information:
    Title
    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
    Secondary Outcome Measure Information:
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    Maximum Observed Concentration (Cmax)
    Time Frame
    Pre-dose, 1 hour (h), 1.5h, 3h, 6h and 8h post-dose on Day 8
    Title
    Trough Concentration (Ctrough)
    Time Frame
    Pre-dose, 1 hour (h), 1.5h, 3h, 6h and 8h post-dose on Day 8
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Key Inclusion Criteria: 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) Key Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Biogen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/
    IPD Sharing URL
    https://vivli.org/

    Learn more about this trial

    Pharmacodynamic Study of BIIB095 and BIIB074 in Healthy Participants and Participants With Painful Diabetic Polyneuropathy

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