Pain, NeuropathicPhase 1NCT04375436
Safety and Tolerability of NTRX-07 in Healthy Volunteers
A Phase 1 study testing NTRX-07-SDD in people with Pain, Neuropathic, run by NeuroTherapia, Inc. at 1 site in United States.
Trial summary
Randomized, placebo-controlled, modified parallel-design single ascending dose (SAD) in adult healthy volunteers (HVs). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Neuropathic
- What is being tested?
- NTRX-07-SDD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2019to 30 Jun 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • 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.
Who cannot join
- 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).
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Orange County Research Center
Tustin, California, 92780
About this study
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
Randomized, placebo-controlled, modified parallel-design single ascending dose (SAD) in adult healthy volunteers (HVs).
Read the 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.
- Conditions
- Pain, Neuropathic
- Being tested
- NTRX-07-SDD
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTRX-07-SDDDrug
Also called MDA7
NTRX-07-SDD for oral administration
| Study group | Role | What they receive |
|---|---|---|
| NTRX-07-SDD | Active comparator | NTRX-07-SDD at 0.3-8mg/kg; single dose Receives: Drug: NTRX-07-SDD |
| Control | Placebo comparator | Placebo control Receives: Drug: NTRX-07-SDD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with treatment emergent adverse events of NTRX-07
Reported Treatment related Adverse Events
Measured: Seven days
Number of subjects with Treatment related subjective effects of NTRX-07
Reported Treatment related subjective effects Events
Measured: Seven days
Plasma levels of NTRX-07
Plasma levels of NTRX-07
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start10 Oct 2019
- Primary completion15 May 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, NeuropathicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study NTRX-07-C101 will be conducted with a modified parallel design, incorporating sentinel subjects and a staggered-dosing-days approach.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroTherapia, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Integrium, Orange County Research Center
- Responsible party
- Sponsor
- Investigators
- Joseph Foss, MD, Study director, NeuroTherapia, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375436
- Sponsor's protocol ID
- NTRX-07-C101
- Status last verified
- Apr 2020
- First submitted
- 13 Apr 2020
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04375436
- Acronym / sponsor ID
- NTRX-07-C101
- Conditions
- Pain, Neuropathic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- NeuroTherapia, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Integrium, Orange County Research Center
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 5 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Study NTRX-07-C101 will be conducted with a modified parallel design, incorporating sentinel subjects and a staggered-dosing-days approach.
| Arm | Type | Receives |
|---|---|---|
| NTRX-07-SDD | Active comparator | Drug: NTRX-07-SDDNTRX-07-SDD at 0.3-8mg/kg; single dose |
| Control | Placebo comparator | Drug: NTRX-07-SDDPlacebo control |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- • Written, informed consent.
- 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
Key exclusion criteria (17 listed)
- Any acute or chronic illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NTRX-07-SDDAlso: MDA7NTRX-07-SDD for oral administration | Drug | Control, NTRX-07-SDD |
Primary outcome
Number of subjects with treatment emergent adverse events of NTRX-07
Time frame: Seven days
Reported Treatment related Adverse Events
Number of subjects with Treatment related subjective effects of NTRX-07
Time frame: Seven days
Reported Treatment related subjective effects Events
Plasma levels of NTRX-07
Time frame: 24 hours
Plasma levels of NTRX-07
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Foss, MD study director
NeuroTherapia, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NTRX-07-SDD in people with Pain, Neuropathic, run by NeuroTherapia, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with treatment emergent adverse events of NTRX-07 (time frame: Seven days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.