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
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- Biogen
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
Part A: BIIB095 Dose 1
Healthy participants and participants with DPN will receive oral dose of BIIB095 Dose 1 capsules from Day 1 to Day 8.
干预措施: BIIB095 (Drug)
Part A: BIIB095 Dose 2
Healthy participants and participants with DPN will receive oral dose of BIIB095 Dose 2 capsules from Day 1 to Day 8.
干预措施: BIIB095 (Drug)
Part A: BIIB095 Dose 3
Healthy participants and participants with DPN will receive oral dose of BIIB095 Dose 3 capsules from Day 1 to Day 8.
干预措施: BIIB095 (Drug)
Part A: BIIB095 Placebo
Healthy participants and participants with DPN will receive oral dose of placebo matching BIIB095 capsules from Day 1 to Day 8.
干预措施: Placebo (Drug)
Part A: Lidocaine
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.
干预措施: Lidocaine (Drug)
Part B: BIIB074 Dose 1
Healthy participants and participants with DPN will receive oral dose of BIIB074 Dose 1 tablets from Day 1 to Day 8.
干预措施: BIIB074 (Drug)
Part B: BIIB074 Placebo
Healthy participants and participants with DPN will receive oral dose of placebo matching BIIB074 tablets from Day 1 to Day 8.
干预措施: Placebo (Drug)
结局指标
主要结局
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
时间窗: Baseline (Day 1), Day 8
次要结局
- 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)
- 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)