DepressionPhase 1NCT01310881
Single-Dose Pharmacokinetics (PK) Study of Novel Neurogenic Compound NSI-189
A Phase 1 study testing NSI-189 Phosphate in people with Depression, run by Neuralstem Inc. at 1 site in United States.
Trial summary
This is a subject single blinded, randomized, placebo-controlled, single dose, first-time-in-human study with three or more ascending cohorts. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- NSI-189 Phosphate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Nov 2011
- 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
- A subject must meet all of the following criteria:
- Subject has the ability to understand the purpose and risks of the study and to provide signed and dated informed consent.
- Males and females between 18 to 55 years of age, inclusive, at the time of informed consent.
- The following applies to female subjects:
- Non-childbearing potential (surgically sterile [hysterectomy or bilateral tubal ligation] or post-menopausal ≥ 1 year with follicle stimulating hormone >40 U/L).
- The following applies to male subjects:
Show all 10Show fewer
- Male subjects with a female partner of childbearing potential will be required to use an effective method of birth control or practice abstinence during this study and for 3 months following discontinuation of IMP.
- Non-smokers (or other nicotine use) as determined by history (no nicotine use over the past year) and by negative urine cotinine test at screening and Day -1.
- BMI ≥ 19.5 and ≤30.0 kg/m2, at screening. Bodyweight must be >50 kg.
- Healthy, determined by pre-study medical evaluation and investigator discretion (medical history, physical examination, vital signs, ECG, and clinical laboratory evaluations).
Who cannot join
- Clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, dermatological or psychiatric disorder(s), or other major disease as determined by the Investigator or designee.
- History of seizures including febrile seizures, loss of consciousness, or any clinically significant finding on the neurologic examination.
- Clinically significant abnormal clinical chemistry values, as determined by the Investigator.
- Clinically significant (as determined by the Investigator) 12-lead ECG abnormalities, including corrected QT interval using Bazett's correction method of >450 msec for males and >470 msec for females.
- History of severe allergic or anaphylactic reactions.
- Subjects who have plans to undergo elective procedures/surgeries at any time during the study through the follow-up visits.
Show all 24Show fewer
- A positive screening test for human immunodeficiency virus (HIV), hepatitis C virus antibody (HCVAb), hepatitis B core antibody (HBcAb), or hepatitis B surface antigen (HBsAg).
- Serious infection (e.g. pneumonia, septicemia) as determined by the Investigator within 3 months prior to Day -1.
- Fever or bacterial, or viral infection (including upper respiratory tract infection) within 2 weeks prior to Day -1.
- Treatment with any prescribed medication within 28 days prior to Day -1.
- Treatment with any over-the-counter products (OTC), including herbal and/or alternative health preparations and procedures within the 14 days prior to Day -1. Note: Intermittent treatment with acetaminophen [≤1000 mg/day] and/or ibuprofen [≤400 mg/day] is permitted.
- Current enrollment in any other drug, biologic, device, or clinical study, or treatment with an investigational product or approved therapy for investigational use within 30 days (or 5 half-lives, whichever is longer) prior to Day -1.
- Any live or attenuated immunization/vaccination within 1 month prior to the study drug administration or planned to occur during the study period.
- Donation of blood (>500 mL) or blood products within 1 month prior to screening.
- History of alcohol or substance abuse (cocaine, amphetamines, barbiturates, opiates, benzodiazepines, cannabinoids, etc.) (as determined by the Investigator).
- Vigorous exercise (as determined by the Investigator) within 48 hours prior to the study drug administration.
- Inability to comply with study requirements.
- Any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs.
- Any concurrent disease or condition that, in the opinion of the Investigator, would make the subject unsuitable for participation in the clinical study.
- Subject unwilling to avoid consumption of coffee and caffeine containing beverages within 48 hours prior to Day -1 until discharge from the clinical site.
- Use of an investigational product within 30 days prior to Day -1.
- Subject is unable to understand the protocol requirements, instructions and study-related restrictions, the nature, scope and possible consequences of the clinical study.
- Subject is unlikely to comply with the protocol requirements, instructions and study-related restrictions.
- Subject has previously been enrolled in this clinical study.
Trial locations and contacts
1 site in 1 country.
United States1 site
California Clinical Trials
Glendale, California, 91206
About this study
Official title: A Phase 1, Randomized, Subject Single Blinded, Placebo-Controlled, Single-Dose Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics (PK) of NSI-189 Phosphate in Healthy Subjects
This is a subject single blinded, randomized, placebo-controlled, single dose, first-time-in-human study with three or more ascending cohorts.
Read the detailed description
Each subject will undergo Screening (Day -28 to Day -2). Subjects will return to the clinical site on Day -1, be admitted to the unit, and eligibility will be reconfirmed. Eligible subjects will receive a single dose of investigational medicinal product (IMP, NSI-189 Phosphate or Placebo) on Day 1 and will be followed for safety and PK until discharge on Day 3. Subjects who are experiencing any significant AEs that are considered possibly related to study drug will be kept at the unit for an additional day (or longer) until the event resolves or it is considered medically safe for the subject to be discharged. Subjects will have a telephone Follow-up on Day 4 and return to the unit on Day 7 (± 1) for End-of-study. Participation of an individual subject may last up to 36 days from the time of Screening until the End-of-study.
- Conditions
- Depression
- Being tested
- NSI-189 Phosphate
- Keywords
- Neurogenesis, hippocampal stem cells, depression, stroke
- Medical subject headings
- Depression, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NSI-189 PhosphateDrug
Once daily oral administration
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 | Experimental | Not described Receives: Drug: NSI-189 Phosphate |
| Dose 2 | Experimental | Not described Receives: Drug: NSI-189 Phosphate |
| Dose 3 | Experimental | Not described Receives: Drug: NSI-189 Phosphate |
| Dose 4 | Experimental | Not described Receives: Drug: NSI-189 Phosphate |
| Dose 5 | Experimental | Not described Receives: Drug: NSI-189 Phosphate |
| Dose 6 | Experimental | Not described Receives: Drug: NSI-189 Phosphate |
| Dose 7 | Experimental | Not described Receives: Drug: NSI-189 Phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of drug assessed by number and severity of adverse events in drug vs placebo groups
Values for vital signs, standard physical examination, ECG, EEG and standard clinical laboratory tests (haematology and biochemistry), and for standard neurological exam and the Columbia Suicide Severity Rating Scale will be compared between NS189 and placebo.
Measured: 7 days
Secondary outcomes (1)
Pharmacokinetics of NS189 will be determined by plasma sample collection at various timepoints post-dosing, and measuring concentration of drug over time.
Concentration of NS189 will be measured in plasma and standard PK values determined: AUC, Cmax, Tmax, T1/2, CL, Vz
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuralstem Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karl Johe, PhD, Study director, Neuralstem Inc.David Han, MD, Principal investigator, California Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01310881
- Sponsor's protocol ID
- NS2010-2
- Status last verified
- May 2011
- First submitted
- 24 Feb 2011
- Last updated
- 21 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Kessler RC, Berglund P, Demler O, Jin R, Koretz D, Merikangas KR, Rush AJ, Walters EE, Wang PS; National Comorbidity Survey Replication. The epidemiology of major depressive disorder: results from the National Comorbidity Survey Replication (NCS-R). JAMA. 2003 Jun 18;289(23):3095-105. doi: 10.1001/jama.289.23.3095.
PubMed 12813115Deng W, Aimone JB, Gage FH. New neurons and new memories: how does adult hippocampal neurogenesis affect learning and memory? Nat Rev Neurosci. 2010 May;11(5):339-50. doi: 10.1038/nrn2822. Epub 2010 Mar 31.
PubMed 20354534DeCarolis NA, Eisch AJ. Hippocampal neurogenesis as a target for the treatment of mental illness: a critical evaluation. Neuropharmacology. 2010 May;58(6):884-93. doi: 10.1016/j.neuropharm.2009.12.013. Epub 2010 Jan 6.
PubMed 20060007Marlatt MW, Lucassen PJ. Neurogenesis and Alzheimer's disease: Biology and pathophysiology in mice and men. Curr Alzheimer Res. 2010 Mar;7(2):113-25. doi: 10.2174/156720510790691362.
PubMed 19860727Kernie SG, Parent JM. Forebrain neurogenesis after focal Ischemic and traumatic brain injury. Neurobiol Dis. 2010 Feb;37(2):267-74. doi: 10.1016/j.nbd.2009.11.002. Epub 2009 Nov 10.
PubMed 19909815Kempermann G, Krebs J, Fabel K. The contribution of failing adult hippocampal neurogenesis to psychiatric disorders. Curr Opin Psychiatry. 2008 May;21(3):290-5. doi: 10.1097/YCO.0b013e3282fad375.
PubMed 18382230
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Subject Single Blinded, Placebo-Controlled, Single-Dose Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics (PK) of NSI-189 Phosphate in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01310881
- Acronym / sponsor ID
- NS2010-2
- Conditions
- Depression
- Keywords
- Neurogenesis, hippocampal stem cells, depression, stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Neuralstem Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 9 Mar 2011 (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.
This is a subject single blinded, randomized, placebo-controlled, single dose, first-time-in-human study with three or more ascending cohorts.
Detailed description
Each subject will undergo Screening (Day -28 to Day -2). Subjects will return to the clinical site on Day -1, be admitted to the unit, and eligibility will be reconfirmed. Eligible subjects will receive a single dose of investigational medicinal product (IMP, NSI-189 Phosphate or Placebo) on Day 1 and will be followed for safety and PK until discharge on Day 3. Subjects who are experiencing any significant AEs that are considered possibly related to study drug will be kept at the unit for an additional day (or longer) until the event resolves or it is considered medically safe for the subject to be discharged. Subjects will have a telephone Follow-up on Day 4 and return to the unit on Day 7 (± 1) for End-of-study. Participation of an individual subject may last up to 36 days from the time of Screening until the End-of-study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Dose 1 | Experimental | Drug: NSI-189 Phosphate |
| Dose 2 | Experimental | Drug: NSI-189 Phosphate |
| Dose 3 | Experimental | Drug: NSI-189 Phosphate |
| Dose 4 | Experimental | Drug: NSI-189 Phosphate |
| Dose 5 | Experimental | Drug: NSI-189 Phosphate |
| Dose 6 | Experimental | Drug: NSI-189 Phosphate |
| Dose 7 | Experimental | Drug: NSI-189 Phosphate |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- A subject must meet all of the following criteria:
Key exclusion criteria (24 listed)
- Clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, dermatological or psychiatric disorder(s), or other major disease as determined by the Investigator or designee.
- History of seizures including febrile seizures, loss of consciousness, or any clinically significant finding on the neurologic examination.
- Clinically significant abnormal clinical chemistry values, as determined by the Investigator.
- Clinically significant (as determined by the Investigator) 12-lead ECG abnormalities, including corrected QT interval using Bazett's correction method of >450 msec for males and >470 msec for females.
- History of severe allergic or anaphylactic reactions.
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 |
|---|---|---|
| NSI-189 PhosphateOnce daily oral administration | Drug | Dose 1, Dose 2, Dose 3, Dose 4, Dose 5, Dose 6, Dose 7 |
Primary outcome
Safety of drug assessed by number and severity of adverse events in drug vs placebo groups
Time frame: 7 days
Values for vital signs, standard physical examination, ECG, EEG and standard clinical laboratory tests (haematology and biochemistry), and for standard neurological exam and the Columbia Suicide Severity Rating Scale will be compared between NS189 and placebo.
1 secondary outcome
Pharmacokinetics of NS189 will be determined by plasma sample collection at various timepoints post-dosing, and measuring concentration of drug over time.
Time frame: 7 days
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 21 Nov 2011.
- Background: PubMed 12813115Kessler RC, Berglund P, Demler O, Jin R, Koretz D, Merikangas KR, Rush AJ, Walters EE, Wang PS; National Comorbidity Survey Replication. The epidemiology of major depressive disorder: results from the National Comorbidity Survey Replication (NCS-R). JAMA. 2003 Jun 18;289(23):3095-105. doi: 10.1001/jama.289.23.3095.
- Background: PubMed 20354534Deng W, Aimone JB, Gage FH. New neurons and new memories: how does adult hippocampal neurogenesis affect learning and memory? Nat Rev Neurosci. 2010 May;11(5):339-50. doi: 10.1038/nrn2822. Epub 2010 Mar 31.
- Background: PubMed 20060007DeCarolis NA, Eisch AJ. Hippocampal neurogenesis as a target for the treatment of mental illness: a critical evaluation. Neuropharmacology. 2010 May;58(6):884-93. doi: 10.1016/j.neuropharm.2009.12.013. Epub 2010 Jan 6.
- Background: PubMed 19860727Marlatt MW, Lucassen PJ. Neurogenesis and Alzheimer's disease: Biology and pathophysiology in mice and men. Curr Alzheimer Res. 2010 Mar;7(2):113-25. doi: 10.2174/156720510790691362.
- Background: PubMed 19909815Kernie SG, Parent JM. Forebrain neurogenesis after focal Ischemic and traumatic brain injury. Neurobiol Dis. 2010 Feb;37(2):267-74. doi: 10.1016/j.nbd.2009.11.002. Epub 2009 Nov 10.
- Background: PubMed 18382230Kempermann G, Krebs J, Fabel K. The contribution of failing adult hippocampal neurogenesis to psychiatric disorders. Curr Opin Psychiatry. 2008 May;21(3):290-5. doi: 10.1097/YCO.0b013e3282fad375.
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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.
Karl Johe, PhD study director
Neuralstem Inc.
David Han, MD principal investigator
California Clinical Trials
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 NSI-189 Phosphate in people with Depression, run by Neuralstem 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 10 inclusion and 24 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 21 Nov 2011. 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?
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?
Safety of drug assessed by number and severity of adverse events in drug vs placebo groups (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01310881, which also lists 6 linked publications.
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 21 Nov 2011.