Clinical trial NCT04106050: 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
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy Volunteers
Diabetic Neuropathies
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2019-09-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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
timeFrame: Baseline (Day 1), Day 8
Secondary outcomes:
measure: 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
timeFrame: Baseline (Day 1), Day 8
measure: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: AEs: Day 1 up to Day 22; SAEs: Screening up to Day 22
measure: Area Under the Curve from Time Zero to Time of the Last Measurable Concentration (AUClast)
timeFrame: Pre-dose, 1 hour (h), 1.5h, 3h, 6h and 8h post-dose on Day 8
measure: Area Under the Curve within a Dosing Interval (AUCtau)
timeFrame: Pre-dose, 1 hour (h), 1.5h, 3h, 6h and 8h post-dose on Day 8
measure: Maximum Observed Concentration (Cmax)
timeFrame: Pre-dose, 1 hour (h), 1.5h, 3h, 6h and 8h post-dose on Day 8
measure: Trough Concentration (Ctrough)
timeFrame: Pre-dose, 1 hour (h), 1.5h, 3h, 6h and 8h post-dose on Day 8
measure: Time to Reach Maximum Observed Concentration (Tmax)
timeFrame: Pre-dose, 1 hour (h), 1.5h, 3h, 6h and 8h post-dose on Day 8
Other outcomes:
Locations:
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: