Diabetic Neuropathies, Healthy Volunteers
Conditions
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.
Interventions
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| Trough Concentration (Ctrough) | Pre-dose, 1 hour (h), 1.5h, 3h, 6h and 8h post-dose on Day 8 |
| Time to Reach Maximum Observed Concentration (Tmax) | 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 |
Outcome results
None listed