Safety and Tolerability of NTRX-07 in Healthy Volunteers

NCT04375436 | Completed Phase 1 FDA Drug

• 1 other identifier: NTRX-07-C101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized, placebo-controlled, modified parallel-design single ascending dose (SAD) in adult healthy volunteers (HVs).

Conditions

Pain, Neuropathic

Outcome Measures

Primary Outcomes (3)

• Number of subjects with treatment emergent adverse events of NTRX-07

  Reported Treatment related Adverse Events

  Seven days

• Number of subjects with Treatment related subjective effects of NTRX-07

  Reported Treatment related subjective effects Events

  Seven days

• Plasma levels of NTRX-07

  Plasma levels of NTRX-07

  24 hours

Study Arms (2)

NTRX-07-SDD

ACTIVE COMPARATOR

NTRX-07-SDD at 0.3-8mg/kg; single dose

Drug: NTRX-07-SDD

Control

PLACEBO COMPARATOR

Placebo control

Drug: NTRX-07-SDD

Interventions

NTRX-07-SDD DRUG

NTRX-07-SDD for oral administration

Also known as: MDA7

Control; NTRX-07-SDD

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Written, informed consent.
• Adult healthy male or females, ages 18-60 years, inclusive, who are surgically sterilized (including hysterectomy and/or bilateral oophorectomy but not tubal ligation) or naturally postmenopausal (2 without menses and documented blood follicle-stimulating hormone ≥40 MIU/mL).
• years
• Good health as determined by medical history, physical examination, vital signs, ECG, and clinical laboratory measurements.
• Clinical laboratories within normal limits at screening (including blood glucose).
• Body mass index (BMI) of 18-35 kg/m 2 inclusive with body weight
• \>50 kg.
• Able to comply with the study regimen.

You may not qualify if:

• Any acute or chronic illness.
• Pregnant or lactating females.
• Positive serology for human immunodeficiency virus (HIV), hepatitis B virus (HBV) (if not vaccinated) or hepatitis C virus (HCV).
• Any known or suspected allergies to the study drug or its constituents.
• Inadequate venous access to allow collection of blood samples.
• History of drug or alcohol abuse, consumption of alcohol within 48 hours prior to treatment assignment, or a positive test for alcohol or drugs with a high potential for abuse prior to treatment assignment and readmission to the Clinical Research Unit (CRU).
• Subjects with history of (within the previous 12 months) or current use of marijuana or positive urine drug screen for cannabinoids at screening or prior to the first dose.
• History of seizures or current existing seizure disorder. High risk for seizure disorders due to underlying medical condition and/or head trauma.
• Is a smoker of more than 10 cigarettes or 3 cigars or 3 pipes per day, and is unable to refrain from smoking while confined to the CRU.
• Calculated creatinine clearance (using Cockroft and Gault formula) \<80 mL/min.
• Resting 12-lead ECG showing QTcB interval \>450 msec or any other clinically significant abnormality in the opinion of the investigator/ sponsor.
• Blood donation, participation in a multiple blood draws clinical study 30 days prior (\>120 mL)
• Major trauma or surgery with or without blood loss within 90 days prior to treatment assignment.
• Use of any experimental or investigational drugs within 30 days prior to treatment assignment.
• Use of any prescription or nonprescription drugs, vitamins, or dietary supplements within 14 days prior to treatment assignment, or expected use during trial enrollment.

Sponsors & Collaborators

• NeuroTherapia, Inc.: lead
• Integrium: collaborator
• Orange County Research Center: collaborator

Study Sites (1)

Orange County Research Center

Tustin, California, 92780, United States

Location

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

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

Study Officials

• Joseph Foss, MD

  NeuroTherapia, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Study NTRX-07-C101 will be conducted with a modified parallel design, incorporating sentinel subjects and a staggered-dosing-days approach.

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: May 5, 2020
• Study Start: October 10, 2019
• Primary Completion: May 15, 2020
• Study Completion: June 30, 2020
• Last Updated: November 8, 2023

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)