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

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ClinicalTrials.gov Identifier: NCT04106050
Recruitment Status : Withdrawn (Sponsor Decision)
First Posted : September 26, 2019
Last Update Posted : March 22, 2021
Sponsor:
Information provided by (Responsible Party):
Biogen

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.


Condition or disease Intervention/treatment Phase
Healthy Volunteers Diabetic Neuropathies Drug: BIIB095 Drug: BIIB074 Drug: Placebo Drug: Lidocaine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : September 30, 2020
Estimated Primary Completion Date : January 21, 2022
Estimated Study Completion Date : January 21, 2022

Arm Intervention/treatment
Experimental: Part A: BIIB095 Dose 1
Healthy participants and participants with DPN will receive oral dose of BIIB095 Dose 1 capsules from Day 1 to Day 8.
Drug: BIIB095
Administered as specified in the treatment arm.

Experimental: Part A: BIIB095 Dose 2
Healthy participants and participants with DPN will receive oral dose of BIIB095 Dose 2 capsules from Day 1 to Day 8.
Drug: BIIB095
Administered as specified in the treatment arm.

Experimental: Part A: BIIB095 Dose 3
Healthy participants and participants with DPN will receive oral dose of BIIB095 Dose 3 capsules from Day 1 to Day 8.
Drug: BIIB095
Administered as specified in the treatment arm.

Placebo Comparator: Part A: BIIB095 Placebo
Healthy participants and participants with DPN will receive oral dose of placebo matching BIIB095 capsules from Day 1 to Day 8.
Drug: Placebo
Administered as specified in the treatment arm.

Active Comparator: Part A: Lidocaine
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.
Drug: Lidocaine
Administered as specified in the treatment arm.

Experimental: Part B: BIIB074 Dose 1
Healthy participants and participants with DPN will receive oral dose of BIIB074 Dose 1 tablets from Day 1 to Day 8.
Drug: BIIB074
Administered as specified in the treatment arm.

Placebo Comparator: Part B: BIIB074 Placebo
Healthy participants and participants with DPN will receive oral dose of placebo matching BIIB074 tablets from Day 1 to Day 8.
Drug: Placebo
Administered as specified in the treatment arm.




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. Maximum Observed Concentration (Cmax) [ Time Frame: Pre-dose, 1 hour (h), 1.5h, 3h, 6h and 8h post-dose on Day 8 ]
  6. Trough Concentration (Ctrough) [ Time Frame: Pre-dose, 1 hour (h), 1.5h, 3h, 6h and 8h post-dose on Day 8 ]
  7. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04106050


Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT04106050    
Other Study ID Numbers: 255NP101
2019-001900-39 ( EudraCT Number )
First Posted: September 26, 2019    Key Record Dates
Last Update Posted: March 22, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetic Neuropathies
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action