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

• Sponsor: Biogen (Industry)
• Overall Status: Withdrawn
• CT.gov ID: NCT04106050
• Collaborator: (none)
• Enrollment: 0
• Arms: 7
• Anticipated Duration (Months): 15.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers; Diabetic Neuropathies	Drug: BIIB095; Drug: BIIB074; Drug: Placebo; Drug: Lidocaine	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Sep 30, 2020
• Anticipated Primary Completion Date: Jan 21, 2022
• Anticipated Study Completion Date: Jan 21, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: BIIB095; Administered as specified in the treatment arm.
Experimental: 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.	Drug: BIIB095; Administered as specified in the treatment arm.
Experimental: 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.	Drug: BIIB095; Administered as specified in the treatment arm.
Placebo Comparator: 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.	Drug: Placebo; Administered as specified in the treatment arm.
Active Comparator: 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.	Drug: Lidocaine; Administered as specified in the treatment arm.
Experimental: 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.	Drug: BIIB074; Administered as specified in the treatment arm.
Placebo Comparator: 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.	Drug: Placebo; Administered as specified in the treatment arm.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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]

2. Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [AEs: Day 1 up to Day 22; SAEs: Screening up to Day 22]

3. 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]

4. 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]

5. Maximum Observed Concentration (Cmax) [Pre-dose, 1 hour (h), 1.5h, 3h, 6h and 8h post-dose on Day 8]

6. Trough Concentration (Ctrough) [Pre-dose, 1 hour (h), 1.5h, 3h, 6h and 8h post-dose on Day 8]

7. Time to Reach Maximum Observed Concentration (Tmax) [Pre-dose, 1 hour (h), 1.5h, 3h, 6h and 8h post-dose on Day 8]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Biogen

Investigators

• Study Director: Medical Director, Biogen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biogen
• ClinicalTrials.gov Identifier: NCT04106050
• Other Study ID Numbers: 255NP101; 2019-001900-39
• First Posted: Sep 26, 2019
• Last Update Posted: Mar 22, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetic Neuropathies; Polyneuropathies; Lidocaine

Study Results

No Results Posted as of Mar 22, 2021