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

NCT04106050 | Withdrawn Phase 1

• 2 other identifiers: 255NP1012019-001900-39
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy Volunteers; Diabetic Neuropathies

Outcome Measures

Primary Outcomes (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

  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

  Baseline (Day 1), Day 8

• Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  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)

  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)

  Pre-dose, 1 hour (h), 1.5h, 3h, 6h and 8h post-dose on Day 8

• Maximum Observed Concentration (Cmax)

  Pre-dose, 1 hour (h), 1.5h, 3h, 6h and 8h post-dose on Day 8

Study Arms (7)

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.

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.

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.

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.

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.

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.

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.

Drug: Placebo

Interventions

BIIB095 DRUG

Administered as specified in the treatment arm.

Part A: BIIB095 Dose 1; Part A: BIIB095 Dose 2; Part A: BIIB095 Dose 3

BIIB074 DRUG

Administered as specified in the treatment arm.

Part B: BIIB074 Dose 1

Placebo DRUG

Administered as specified in the treatment arm.

Part A: BIIB095 Placebo; Part B: BIIB074 Placebo

Lidocaine DRUG

Administered as specified in the treatment arm.

Part A: Lidocaine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Biogen: lead

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

vixotrigine; Lidocaine

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: September 26, 2019
• Study Start: September 30, 2020
• Primary Completion: January 21, 2022
• Study Completion: January 21, 2022
• Last Updated: March 22, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share