Major Depressive DisorderPhase 1NRX-1074NCT02366364
Study of Safety, Tolerability and Pharmacokinetics of NRX-1074 in Normal Healthy Volunteers
A Phase 1 study testing NRX-1074 375 mg, NRX-1074 500 mg and NRX-1074 750 mg in people with Major Depressive Disorder, run by Naurex, Inc, an affiliate of Allergan plc at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety and tolerability of multiple oral (PO) ascending doses of NRX-1074 in normal healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- NRX-1074 375 mg, NRX-1074 500 mg and NRX-1074 750 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Apr 2015
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female subjects
- Aged 18 to 55 years
- For female subjects, surgically sterile or at least 2 years menopausal, or using an acceptable method of birth control. If of childbearing potential, have a documented negative blood or urine pregnancy test within 24 hours prior to dosing.
- Clinical laboratory values <2 times upper limit of normal (ULN) or deemed not clinically significant by the investigator
- Ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments
Who cannot join
- Human immunodeficiency virus (HIV) infection, or hepatitis or other ongoing infectious disease.
- Current evidence of alcohol abuse (greater than 4 units of alcohol on most days; 1 unit = 1/2 pint of beer, 1 glass of wine or 1 oz. of spirits), or in the option of the investigator that subject may be alcoholic.
- Current abuse of illicit substances, using the Diagnostic and Statistical Manual (DSM) IV definition of drug abuse.
- Current smoker or use of other tobacco products.
- Currently pregnant, planning to become pregnant during the course of the study, or nursing mother.
- Type I or Type II diabetes.
Show all 12Show fewer
- Malignancy in the last 5 years, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
- Currently taking prescription or over-the-counter medications including herbal therapies, within 14 days of enrollment into the study.
- History of allergy, sensitivity, or intolerance to NMDAR ligands including ketamine, dextromethorphan, memantine, methadone, dextropropoxyphene, or ketobemidone or concomitant use of such agents.
- Received another investigational drug or device within 30 days of enrollment in this study.
- Previously participated in this study.
- Psychiatric disease including major depression, bipolar disorder, anxiety, or schizophrenia, or other medical condition that, in the opinion of the investigator, would interfere with the evaluation of the study drug safety. 13) In the option of the Investigator or the Sponsor's Study Monitor, has a history of severe renal or hepatic impairment, severe active hepatic disease, or other clinically significant medical condition that may preclude safe study participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Chicago Research Center, Inc.
Chicago, Illinois, 60634
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Multiple Oral Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of NRX-1074 in Normal Healthy Volunteers
The purpose of this study is to assess the safety and tolerability of multiple oral (PO) ascending doses of NRX-1074 in normal healthy volunteers.
Read the detailed description
NRX-1074 is a N-methyl-D-aspartate (NMDA) receptor functional partial agonist with efficacy in animal models of affective disorders including major depressive disorder. The purpose of this study is to evaluate the safety and tolerability of multiple oral (PO) ascending doses of NRX-1074 as evidenced by the incidence and severity of adverse events (AEs), changes in serum chemistry, hematology, and urinalysis, changes in physical examination findings, psychotomimetic findings and subject-reported symptoms.
- Conditions
- Major Depressive Disorder
- Being tested
- Placebo, NRX-1074 375 mg, NRX-1074 500 mg, NRX-1074 750 mg
- Keywords
- NRX-1074, NMDA Receptor Modulator, Major Depressive Disorder, Glycine Site Modulator
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Single oral administration of placebo consumption on Day 1
NRX-1074 375 mgDrug
Also called NRX-1074 single oral dose
Single oral administration of 375 mg consumption on Day 1
NRX-1074 500 mgDrug
Also called NRX-1074 single oral dose
Single oral administration of 500 mg consumption on Day 1
NRX-1074 750 mgDrug
Also called NRX-1074 single oral dose
Single oral administration of 750 mg consumption on Day 1
| Study group | Role | What they receive |
|---|---|---|
| Drug: Placebo | Placebo comparator | Single oral administration on Day 1 Receives: Drug: Placebo |
| Drug: NRX-1074 375 mg | Experimental | Single oral administration on Day 1 Receives: Drug: NRX-1074 375 mg |
| Drug: NRX-1074 500 mg | Experimental | Single oral administration on Day 1 Receives: Drug: NRX-1074 500 mg |
| Drug: NRX-1074 750 mg | Experimental | Single oral administration on Day 1 Receives: Drug: NRX-1074 750 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as a measure of safety and tolerability
Observed side effects and changes in laboratory values
Measured: 28 days following study drug dose
Secondary outcomes (2)
Plasma pharmacokinetics Cmax
Cmax after administration
Measured: For 24 hours after drug dose on Day 1
Plasma pharmacokinetics - Tmax
Tmax after administration
Measured: For 24 hours after drug dose on Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Naurex, Inc, an affiliate of Allergan plc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mimi Van Der Leden, MD, PhD, Principal investigator, Chicago Research Center, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02366364
- Sponsor's protocol ID
- NRX1074-C-102
- Acronym
- NRX-1074
- Status last verified
- Feb 2016
- First submitted
- 29 Jan 2015
- Last updated
- 22 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Multiple Oral Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of NRX-1074 in Normal Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02366364
- Acronym / sponsor ID
- NRX-1074 / NRX1074-C-102
- Conditions
- Major Depressive Disorder
- Keywords
- NRX-1074, NMDA Receptor Modulator, Major Depressive Disorder, Glycine Site Modulator
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Naurex, Inc, an affiliate of Allergan plcIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 19 Feb 2015 (estimated)
- 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.
The purpose of this study is to assess the safety and tolerability of multiple oral (PO) ascending doses of NRX-1074 in normal healthy volunteers.
Detailed description
NRX-1074 is a N-methyl-D-aspartate (NMDA) receptor functional partial agonist with efficacy in animal models of affective disorders including major depressive disorder. The purpose of this study is to evaluate the safety and tolerability of multiple oral (PO) ascending doses of NRX-1074 as evidenced by the incidence and severity of adverse events (AEs), changes in serum chemistry, hematology, and urinalysis, changes in physical examination findings, psychotomimetic findings and subject-reported symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Drug: Placebo | Placebo comparator | Drug: PlaceboSingle oral administration on Day 1 |
| Drug: NRX-1074 375 mg | Experimental | Drug: NRX-1074 375 mgSingle oral administration on Day 1 |
| Drug: NRX-1074 500 mg | Experimental | Drug: NRX-1074 500 mgSingle oral administration on Day 1 |
| Drug: NRX-1074 750 mg | Experimental | Drug: NRX-1074 750 mgSingle oral administration on Day 1 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male and female subjects
- Aged 18 to 55 years
- For female subjects, surgically sterile or at least 2 years menopausal, or using an acceptable method of birth control. If of childbearing potential, have a documented negative blood or urine pregnancy test within 24 hours prior to dosing.
- Clinical laboratory values <2 times upper limit of normal (ULN) or deemed not clinically significant by the investigator
- Ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments
Key exclusion criteria (12 listed)
- Human immunodeficiency virus (HIV) infection, or hepatitis or other ongoing infectious disease.
- Current evidence of alcohol abuse (greater than 4 units of alcohol on most days; 1 unit = 1/2 pint of beer, 1 glass of wine or 1 oz. of spirits), or in the option of the investigator that subject may be alcoholic.
- Current abuse of illicit substances, using the Diagnostic and Statistical Manual (DSM) IV definition of drug abuse.
- Current smoker or use of other tobacco products.
- Currently pregnant, planning to become pregnant during the course of the study, or nursing mother.
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 |
|---|---|---|
| PlaceboSingle oral administration of placebo consumption on Day 1 | Drug | Drug: Placebo |
| NRX-1074 375 mgAlso: NRX-1074 single oral doseSingle oral administration of 375 mg consumption on Day 1 | Drug | Drug: NRX-1074 375 mg |
| NRX-1074 500 mgAlso: NRX-1074 single oral doseSingle oral administration of 500 mg consumption on Day 1 | Drug | Drug: NRX-1074 500 mg |
| NRX-1074 750 mgAlso: NRX-1074 single oral doseSingle oral administration of 750 mg consumption on Day 1 | Drug | Drug: NRX-1074 750 mg |
Primary outcome
Number of participants with adverse events as a measure of safety and tolerability
Time frame: 28 days following study drug dose
Observed side effects and changes in laboratory values
2 secondary outcomes
Plasma pharmacokinetics Cmax
Time frame: For 24 hours after drug dose on Day 1
Plasma pharmacokinetics - Tmax
Time frame: For 24 hours after drug dose on Day 7
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 22 Feb 2016.
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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.
Mimi Van Der Leden, MD, PhD principal investigator
Chicago Research Center, 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 NRX-1074 375 mg, NRX-1074 500 mg and NRX-1074 750 mg in people with Major Depressive Disorder, run by Naurex, Inc, an affiliate of Allergan plc 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 5 inclusion and 12 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 22 Feb 2016. 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 participants with adverse events as a measure of safety and tolerability (time frame: 28 days following study drug dose). 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 22 Feb 2016.