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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04106050
• Other study ID #: 255NP101
• Secondary ID: 2019-001900-39
• Status: Withdrawn
• Phase: Phase 1
• Start date: September 30, 2020
• Est. completion date: January 21, 2022

Study information

• Verified date: March 2021
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 21, 2022
• Est. primary completion date: January 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Healthy Volunteers
• Polyneuropathies

Intervention

Drug:
• BIIB095
Administered as specified in the treatment arm.
• BIIB074
Administered as specified in the treatment arm.
• Placebo
Administered as specified in the treatment arm.
• Lidocaine
Administered as specified in the treatment arm.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)		AEs: Day 1 up to Day 22; SAEs: Screening up to Day 22
Secondary	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
Secondary	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
Secondary	Maximum Observed Concentration (Cmax)		Pre-dose, 1 hour (h), 1.5h, 3h, 6h and 8h post-dose on Day 8
Secondary	Trough Concentration (Ctrough)		Pre-dose, 1 hour (h), 1.5h, 3h, 6h and 8h post-dose on Day 8
Secondary	Time to Reach Maximum Observed Concentration (Tmax)		Pre-dose, 1 hour (h), 1.5h, 3h, 6h and 8h post-dose on Day 8