SchizophreniaPhase 1NCT01955564
A Phase I- Sequential Cohort Dosing to Determine Maximum Tolerated Dose in Healthy Male Volunteers.
A Phase 1 study testing NW-3509a in people with Schizophrenia, run by Newron Pharmaceuticals SPA at 1 site in United States.
Trial summary
This is a prospective, 8-day, randomized, double-blind, placebo-controlled, sequential-cohort study designed to evaluate the safety, tolerability, and MTD of single escalating oral doses of NW-3509A in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- NW-3509a
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Feb 2015
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Demographics
- Volunteers will meet the following demographic inclusion criteria:
- Age - between 18 and 45 years of age, inclusive.
- Sex - males.
- The subject has a body weight of at least 45 kg and a body mass index of ≤30.
- Procedural
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- Volunteers will meet the following procedural criteria:
- They are cooperative, able to take oral medication, willing to complete all aspects of the study, and capable of doing so.
- They will be able to understand the instructions and fully participate.
- They will have provided written informed consent prior to participating in the study.
- The subject is in good health with no history of significant medical disease as determined by the investigator.
Who cannot join
- The presence of any of the following will exclude a subject from study enrollment:
- General Medical Status
- An advanced, severe, or unstable disease of any type that may interfere with any of the study evaluations, including any medical condition that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical or mental status of the volunteer to a significant degree or put the volunteer at special risk (e.g., liver or kidney disease; malignancy);
- A disability that may prevent the volunteer from completing all study requirements (e.g., blindness, deafness, severe language difficulty);
- A current diagnosis of active, uncontrolled peptic ulceration within the last year;
- A current diagnosis of acute, severe, or unstable asthmatic condition.
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- Cardiovascular
- A current diagnosis of severe or unstable cardiovascular disease;
- A current diagnosis of sick-sinus syndrome or conduction deficits (e.g., sino-atrial block (<0.22), second or third degree atrio-ventricular block);
- Any history or current evidence of a cardiac illness as determined by the investigator;
- Any clinically significant ECG abnormality, including a disorder of rate, rhythm, or conduction, or other morphological changes, or a QTcF interval (Fridericia's correction formula) on the ECG >450 msec. The 12-lead ECG will be used for determining the suitability of the subject for inclusion in the study (determined by the investigator);
- Vital signs (supine) outside the following ranges:
- Systolic blood pressure below 100 or above 139 mmHg;
- Diastolic blood pressure below 50 or above 89 mmHg;
- Radial pulse below 50 or above 90 bpm.
- CNS related
- Any history or current diagnosis of any neurodegenerative illness;
- History or current diagnosis of epilepsy or seizure disorder.
- Psychiatric
- Any past or current psychiatric illness (DSM-IV-TR Axis 1 diagnosis);
- Subjects with current or past suicidal ideation.
- Study-specific criteria
- History of serious adverse reactions or hypersensitivity to any drug;
- Presence or history of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis);
- Alcohol or drug abuser; currently or at any time in the last 5 years;
- Abnormal physical findings of clinical significance at the screening examination or baseline that would interfere with the objectives of the study;
- Need of any prescription medication within 14 days prior to the administration of the study drug, and/or non-prescription medication within 7 days prior to the administration of the drug;
- Participation in other clinical trials during the last 2 months in which an investigational drug or a commercially available drug was tested;
- Loss of 500 ml or more of blood during the 3-month period before the study, e.g. as a donor.
- Existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the study drug, i.e. impaired renal or hepatic function, diabetes mellitus, cardiovascular abnormalities, inflammatory bowel disease, chronic symptoms of pronounced constipation or diarrhea, or conditions associated with total or partial obstruction of the urinary tract;
- Symptoms of a significant somatic or mental illness in the four-week period preceding study drug administration;
- History of hepatitis B and/or C, and/or positive serology results, which indicate the presence of hepatitis B and/or C (Hepatitis B surface antigen and/or antibody to Hepatitis C);
- Positive results from the HIV serology;
- Positive results of the drug and alcohol tests at screening and/or check-in at the unit;
- Smoker; currently or at any time in the last 5 years;
- Laboratory abnormalities
- Clinically significant abnormalities in routine laboratory examinations (hematology; blood chemistry, including electrolytes and liver and kidney function tests; urinalysis), as determined by the Principal Investigator in consultation with the Sponsor, at the screening evaluation;
- Clinically important laboratory abnormalities in thyroid function tests at screening:
- TSH > 8.0 mU/L and/or Free T4 < 9 pmol/L;
- Concomitant therapy
- A known exaggerated pharmacological sensitivity or hypersensitivity to drugs similar to NW-3509A. Possible examples are volunteers who have experienced hypersensitivity reactions to sodium channel blockers;
- Ingested any of the following substances:
- An investigational drug during the past 2 months;
- A drug or treatment known to cause major organ system toxicity during the past year;
- Any prescription drug or OTC product if taken continuously (Medical Monitor from Newron should be contacted if the Investigator wants to include a volunteer who is taking an OTC product);
- Alcohol intake should be limited to 2 drinks per day during the 2 weeks prior to dosing; alcohol consumption will be prohibited from 72 hours prior to admittance on Day -1 through to the final safety evaluations on Day 8.
- Caffeine-containing products should be limited (equivalent of 2 cups of coffee per day) during the 2 weeks prior to dosing and through to the final safety evaluations on Day 8.
Trial locations and contacts
1 site in 1 country.
United States1 site
Collaborative Neuroscience Network-Clinical Pharmacology Unit
Long Beach, California, 90806
About this study
Official title: A Phase I, Prospective, Randomized, Double-blind, Placebo-controlled, Sequential-cohort, Escalating, Single-dose Study Designed to Determine the Maximum Tolerated Oral Dose of NW-3509A in Healthy, Male Volunteers.
This is a prospective, 8-day, randomized, double-blind, placebo-controlled, sequential-cohort study designed to evaluate the safety, tolerability, and MTD of single escalating oral doses of NW-3509A in healthy male volunteers. Six independent cohorts of 12 volunteers each will participate in this study, with the first 9 volunteers in each cohort to qualify being randomized to receive study medication and the remaining 3 to be used as backups/ alternates. In each cohort, 6 subjects will be randomly assigned to receive NW-3509A and 3 subjects will receive placebo.
Read the detailed description
Doses from 1 to 30 mg were tested
- Conditions
- Schizophrenia
- Being tested
- NW-3509a
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NW-3509aDrug
Also called NW-3509
single dose
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | NW-3509a - 1mg or placebo Receives: Drug: NW-3509a |
| Cohort 2 | Experimental | NW-3509a 2mg or placebo Receives: Drug: NW-3509a |
| Cohort 3 | Experimental | NW-3509a 5mg or placebo Receives: Drug: NW-3509a |
| Cohort 4 | Experimental | NW-3509a 10 mg or placebo Receives: Drug: NW-3509a |
| Cohort 5 | Experimental | NW-3509a 20 mg or placebo Receives: Drug: NW-3509a |
| Cohort 6 | Experimental | NW-3509a 30 mg or placebo Receives: Drug: NW-3509a |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Examination Shift Table
Physical examinations were carried out on the following: Lymph nodes, mouth, neck, nervous system, nose, skin and throat.
Measured: Day -1(pre-dose) through Day 8 (Discharge)
Secondary outcomes (2)
Maximum Plasma Concentration of NW-3509A at Doses Tested
Plasma concentration data, derived PK parameters, and urine data are summarized as maximum plasma concentration (Cmax).
The plasma concentrations of NW-3509A in the samples taken from the subjects receiving placebo were below the limit of quantification (<1.00 ng/mL) in all cases (n=18).
Measured: Baseline up to 32 hours post-dose
Total Drug Exposure Over Time (AUC0-t) of NW-3509A at Doses Tested
Plasma concentration data, derived PK parameters, and urine data were summarized as total drug exposure over time (AUC0-t).
The plasma concentrations of NW-3509A in the samples taken from the subjects receiving placebo were below the limit of quantification (<1.00 ng/mL) in all cases (n=18).
Measured: Baseline up to 32 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newron Pharmaceuticals SPA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Leibowitz, MD, Principal investigator, Collaborative Neuroscience Network Phase I UnitRavi Anand, MD, Study director, Newron Pharmaceuticals SPA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01955564
- Sponsor's protocol ID
- NW-3509A/001/I/2011
- Status last verified
- Apr 2017
- First submitted
- 21 Aug 2013
- Last updated
- 20 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Prospective, Randomized, Double-blind, Placebo-controlled, Sequential-cohort, Escalating, Single-dose Study Designed to Determine the Maximum Tolerated Oral Dose of NW-3509A in Healthy, Male Volunteers.
- ClinicalTrials.gov ID
- NCT01955564
- Acronym / sponsor ID
- NW-3509A/001/I/2011
- Conditions
- Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Newron Pharmaceuticals SPAIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 7 Oct 2013 (estimated)
- Results
- Posted 20 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, 8-day, randomized, double-blind, placebo-controlled, sequential-cohort study designed to evaluate the safety, tolerability, and MTD of single escalating oral doses of NW-3509A in healthy male volunteers. Six independent cohorts of 12 volunteers each will participate in this study, with the first 9 volunteers in each cohort to qualify being randomized to receive study medication and the remaining 3 to be used as backups/ alternates. In each cohort, 6 subjects will be randomly assigned to receive NW-3509A and 3 subjects will receive placebo.
Detailed description
Doses from 1 to 30 mg were tested
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: NW-3509aNW-3509a - 1mg or placebo |
| Cohort 2 | Experimental | Drug: NW-3509aNW-3509a 2mg or placebo |
| Cohort 3 | Experimental | Drug: NW-3509aNW-3509a 5mg or placebo |
| Cohort 4 | Experimental | Drug: NW-3509aNW-3509a 10 mg or placebo |
| Cohort 5 | Experimental | Drug: NW-3509aNW-3509a 20 mg or placebo |
| Cohort 6 | Experimental | Drug: NW-3509aNW-3509a 30 mg or placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Demographics
- Age - between 18 and 45 years of age, inclusive.
- Sex - males.
- The subject has a body weight of at least 45 kg and a body mass index of ≤30.
- Procedural
Key exclusion criteria (47 listed)
- General Medical Status
- An advanced, severe, or unstable disease of any type that may interfere with any of the study evaluations, including any medical condition that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical or mental status of the volunteer to a significant degree or put the volunteer at special risk (e.g., liver or kidney disease; malignancy);
- A disability that may prevent the volunteer from completing all study requirements (e.g., blindness, deafness, severe language difficulty);
- A current diagnosis of active, uncontrolled peptic ulceration within the last year;
- A current diagnosis of acute, severe, or unstable asthmatic condition.
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 |
|---|---|---|
| NW-3509aAlso: NW-3509single dose | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6 |
Primary outcome
Physical Examination Shift Table
Time frame: Day -1(pre-dose) through Day 8 (Discharge)
Physical examinations were carried out on the following: Lymph nodes, mouth, neck, nervous system, nose, skin and throat.
2 secondary outcomes
Maximum Plasma Concentration of NW-3509A at Doses Tested
Time frame: Baseline up to 32 hours post-dose
Total Drug Exposure Over Time (AUC0-t) of NW-3509A at Doses Tested
Time frame: Baseline up to 32 hours post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Mark Leibowitz, MD principal investigator
Collaborative Neuroscience Network Phase I Unit
Ravi Anand, MD study director
Newron Pharmaceuticals SPA
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 NW-3509a in people with Schizophrenia, run by Newron Pharmaceuticals SPA 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 11 inclusion and 47 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 20 Jun 2017. 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. 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?
Yes. Results are posted in the registry (first posted 20 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Physical Examination Shift Table (time frame: Day -1(pre-dose) through Day 8 (Discharge)). 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 20 Jun 2017.