Titration Study of ABX-1431

NCT03447756 | Completed Phase 1

• 1 other identifier: ABX-1431_PN014
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to identify a titration regimen of ABX-1431 in adults with neuropathic pain with satisfactory tolerability to central nervous system (CNS) adverse events (AEs). During the course of this study, each participant will take a daily dose of ABX-1431 or a matching placebo for 28 days.

Conditions

Post Herpetic Neuralgia; Diabetic Peripheral Neuropathy; Small Fiber Neuropathy; Post-Traumatic Neuralgia

Outcome Measures

Primary Outcomes (1)

• Identify a titration regimen of ABX-1431

  The number of patients unable to continue due to central nervous system (CNS) adverse events (AEs) while exceeding mean plasma ABX-1431 AUC\_0-24 of 190 ng\*hr/ml or inhibiting 2-arachidonoylglycerol (2-AG) hydrolysis in peripheral blood mononuclear cells (PBMC) by more than 62% time-weighted inhibition over 24-hours.

  28 days

Secondary Outcomes (2)

• Tolerance to ABX-1431 related CNS AEs determined by whether or not AEs resolve with continued dosing

  28 days

• Numerical Rating Scale (NRS-11)

  20 days

Study Arms (2)

ABX-1431

EXPERIMENTAL

One or more oral capsules containing 2 mg or 10 mg or 50 mg of ABX-1431 HCl or matching placebo are administered daily to enrolled patients. Patients will undergo a blinded dose escalation. All patients will receive placebo on some days to assess safety and neuropathic pain. Patients will undergo an optimized titration of ABX-1431 HCl with the daily dose between 8 mg and 24 mg of ABX-1431. Each patients dose will be determined by the Investigator based on assessment of adverse events.

Drug: ABX-1431

Placebo oral capsule

PLACEBO COMPARATOR

One or more oral capsules containing placebo are administered daily to enrolled patients. Patients will undergo a blinded dose escalation. All patients will receive placebo on some days to assess safety and neuropathic pain. Patients will undergo an optimized titration of placebo. Each patients dose will be determined by the Investigator based on assessment of adverse events.

Drug: Placebo oral capsule

Interventions

ABX-1431 DRUG

Capsules of either 2mg, 10mg, or 50mg

ABX-1431

Placebo oral capsule DRUG

placebo to match

Placebo oral capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is a male or female over the age of 18 years of age at the Screening Visit.
• Patient has a peripheral neuropathic pain in one of the following diagnostic groups that is persistent for \> 3 months
• Post-herpetic neuralgia
• Diabetic peripheral neuropathy
• Small fiber neuropathy
• Post-traumatic neuropathic pain
• Patient's median NRS-11 pain intensity score must be ≥ 4 during the baseline period
• If a patient enters the trial on daily background neuropathic pain medications, then the patient must be on stable dose of medications for at least 30 days before enrollment and throughout the study.
• Patient is able to understand and comply with the protocol procedures for the entire trial and must give written informed consent.
• Men and Women must agree to a medically approved contraceptive regimen.

You may not qualify if:

• Patient is taking potent cytochrome P450 3A4/5 inducers or inhibitors
• Patient has received injection therapies (e.g., botulinum toxin, anesthetic or nerve block) or transcutaneous electrical stimulation to control pain in the past 60 days
• Patient has evidence of alcohol, drug or chemical abuse in the year before the Screening Visit.
• Patient is a lactating or pregnant female or a female who intends to become pregnant within 90 days following the last dose of investigational product.
• Patient has specific laboratory abnormalities

Sponsors & Collaborators

• Abide Therapeutics: lead

Study Sites (1)

Republican Clinical Hospital

Chisinau, MD-2025, Moldova

Location

MeSH Terms

Conditions

Neuralgia, Postherpetic; Small Fiber Neuropathy

Interventions

ABX-1431

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Vitale Lisnic, PhD

  ARENSIA EXPLORATORY MEDICINE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2018
• First Posted: February 27, 2018
• Study Start: October 2, 2017
• Primary Completion: May 7, 2019
• Study Completion: May 7, 2019
• Last Updated: July 12, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1)