Safety and Tolerability of NTRX-07 in Healthy Volunteers
Primary Purpose
Pain, Neuropathic
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NTRX-07-SDD
Sponsored by
About this trial
This is an interventional basic science trial for Pain, Neuropathic
Eligibility Criteria
Inclusion Criteria:
• 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.
Exclusion Criteria:
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.
- Any current condition, that in either the Investigator's or sponsor's opinion would represent an unacceptable safety risk while participating in this study or interfere with trial participation or evaluation of results.
- Severe mental incapacity, unwillingness, language barrier, serious behavioral issues, evidence of substance abuse, or any other situation, which would preclude an understanding of, and adherence to study procedures
Sites / Locations
- Orange County Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
NTRX-07-SDD
Control
Arm Description
NTRX-07-SDD at 0.3-8mg/kg; single dose
Placebo control
Outcomes
Primary Outcome Measures
Number of subjects with treatment emergent adverse events of NTRX-07
Reported Treatment related Adverse Events
Number of subjects with Treatment related subjective effects of NTRX-07
Reported Treatment related subjective effects Events
Plasma levels of NTRX-07
Plasma levels of NTRX-07
Secondary Outcome Measures
Full Information
NCT ID
NCT04375436
First Posted
April 13, 2020
Last Updated
May 4, 2020
Sponsor
NeuroTherapia, Inc.
Collaborators
Integrium, Orange County Research Center
1. Study Identification
Unique Protocol Identification Number
NCT04375436
Brief Title
Safety and Tolerability of NTRX-07 in Healthy Volunteers
Official Title
NTRX 07-C101: A Phase 1, Randomized, Placebo-Controlled, Modified Parallel Design Single Ascending Dose Study of NTRX 07 to Assess Safety and Tolerability and Pharmacokinetics in Adult Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 10, 2019 (Actual)
Primary Completion Date
May 15, 2020 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NeuroTherapia, Inc.
Collaborators
Integrium, Orange County Research Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Randomized, placebo-controlled, modified parallel-design single ascending dose (SAD) in adult healthy volunteers (HVs).
Detailed Description
Study NTRX-07-C101 will be conducted with a modified parallel design, incorporating sentinel subjects and a staggered-dosing-days approach.
Up to 6 cohorts, A-F, are planned for a total of 48 completing subjects. Each dose cohort will be randomized with 6 subjects receiving active drug and 2 placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Neuropathic
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Study NTRX-07-C101 will be conducted with a modified parallel design, incorporating sentinel subjects and a staggered-dosing-days approach.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blind
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NTRX-07-SDD
Arm Type
Active Comparator
Arm Description
NTRX-07-SDD at 0.3-8mg/kg; single dose
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebo control
Intervention Type
Drug
Intervention Name(s)
NTRX-07-SDD
Other Intervention Name(s)
MDA7
Intervention Description
NTRX-07-SDD for oral administration
Primary Outcome Measure Information:
Title
Number of subjects with treatment emergent adverse events of NTRX-07
Description
Reported Treatment related Adverse Events
Time Frame
Seven days
Title
Number of subjects with Treatment related subjective effects of NTRX-07
Description
Reported Treatment related subjective effects Events
Time Frame
Seven days
Title
Plasma levels of NTRX-07
Description
Plasma levels of NTRX-07
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
• 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.
Exclusion Criteria:
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.
Any current condition, that in either the Investigator's or sponsor's opinion would represent an unacceptable safety risk while participating in this study or interfere with trial participation or evaluation of results.
Severe mental incapacity, unwillingness, language barrier, serious behavioral issues, evidence of substance abuse, or any other situation, which would preclude an understanding of, and adherence to study procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Foss, MD
Organizational Affiliation
NeuroTherapia, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Orange County Research Center
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Safety and Tolerability of NTRX-07 in Healthy Volunteers
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