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

Biogen

Status and phase: Withdrawn; Phase 1

Conditions: Healthy Volunteers; Diabetic Neuropathies

Treatments: Drug: BIIB095; Drug: Lidocaine; Drug: BIIB074; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04106050

255NP101

2019-001900-39 (EudraCT Number)

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 7 patient groups, including a placebo group

Part A: BIIB095 Dose 1

Experimental group

Description:

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

Treatment:

Drug: BIIB095

Part A: BIIB095 Dose 2

Experimental group

Description:

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

Treatment:

Drug: BIIB095

Part A: BIIB095 Dose 3

Experimental group

Description:

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

Treatment:

Drug: BIIB095

Part A: BIIB095 Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Part A: Lidocaine

Active Comparator group

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.

Treatment:

Drug: Lidocaine

Part B: BIIB074 Dose 1

Experimental group

Description:

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

Treatment:

Drug: BIIB074

Part B: BIIB074 Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo