Attention Deficit Disorder With HyperactivityPhase 1NCT03006367
Pharmacokinetic and Tolerability Study of NFC-1 in Subjects Aged 6-17 Years With ADHD
A Phase 1 study testing NFC-1 100 mg, NFC-1 200 mg and NFC-1 400 mg in people with Attention Deficit Disorder With Hyperactivity, run by Aevi Genomic Medicine, LLC, a Cerecor company at 3 sites in United States.
Trial summary
This is a open-label, single ascending dose, pharmacokinetic, and tolerability study of NFC-1 in Children and Adolescents (Ages 6-17 Years) with ADHD. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- NFC-1 100 mg, NFC-1 200 mg and NFC-1 400 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 Jan 2017to 6 Mar 2017
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject and parent/legally authorized representative (LAR) are able to speak English fluently and have provided written informed consent, and assent (as applicable) for this study.
- Subject is 6 to 17 years inclusive at the time of consent/assent.
- Subject is male, female of non-childbearing potential or non-pregnant, non-lactating female of childbearing potential who agrees to comply with any applicable contraceptive requirements 2 weeks prior to administration of IP and throughout the study.
- Subject meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for a primary diagnosis of ADHD based on a M.I.N.I. International Neuropsychiatric Interview.
- Subject is considered "healthy". Healthy status is defined by absence of evidence of any active or chronic disease other than their ADHD following a detailed medical and surgical history, a complete physical examination.
- Subject has the ability to swallow a capsule of investigational product whole.
Who cannot join
- Subject has a history of any hematological, hepatic, respiratory, cardiovascular, renal, neurological, or psychiatric disease, gall bladder removal, or current or recurrent disease other than their ADHD.
- Subject has a current or relevant history of physical or psychiatric illness, or any medical disorder that may require treatment.
- Subject has a current, controlled or uncontrolled, comorbid psychiatric diagnosis with significant symptoms.
- Subject is considered a suicide risk in the opinion of the investigator, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation.
- Subject has used an investigational product, been enrolled in a clinical study including vaccines, or had any changes in eating habits, within 30 days prior to the first dose of investigational product.
- Subject has a positive screen for alcohol or drugs of abuse, or a positive hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), or HIV antibody screen.
Show all 11Show fewer
- Subject previously was an adolescent (12-17) who was either a screen failure, or enrolled or participated in this study or another NFC1 clinical study.
- Subject is currently taking any medication that might confound the results of safety assessments conducted in the study.
- Subject has a concurrent chronic or acute illness, disability, or other condition that might confound the results of safety assessments conducted in the study.
- Subject is unwilling to discontinue current ADHD medication to participate in the study.
- Subject has a clinical laboratory abnormality that indicates clinically significant hematologic, hepatobiliary, or renal disease.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Center for Psychiatry and Behavioral Medicine
Las Vegas, Nevada, 89128
Meridien Research, Inc.
Maitland, Florida, 32751
QPS-MRA, LLC (Miami Research Associates)
Miami, Florida, 33143
About this study
Official title: An Open-label, Single Ascending Dose, Pharmacokinetic and Tolerability Study of NFC-1 in Children and Adolescents (Ages 6-17 Years) With Attention Deficit Hyperactivity Disorder
This is a open-label, single ascending dose, pharmacokinetic, and tolerability study of NFC-1 in Children and Adolescents (Ages 6-17 Years) with ADHD.
- Being tested
- NFC-1 100 mg, NFC-1 200 mg, NFC-1 400 mg, NFC-1 800 mg
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NFC-1 100 mgDrug
Also called AEVI-001, MDGN-001
NFC-1 200 mgDrug
Also called AEVI-001, MDGN-001
NFC-1 400 mgDrug
Also called AEVI-001, MDGN-001
NFC-1 800 mgDrug
Also called AEVI-001, MDGN-001
| Study group | Role | What they receive |
|---|---|---|
| NFC-1 100 mg | Experimental | Single Dose of NFC-1 100 mg Receives: Drug: NFC-1 100 mg |
| NFC-1 200 mg | Experimental | Single Dose of NFC-1 200 mg Receives: Drug: NFC-1 200 mg |
| NFC-1 400 mg | Experimental | Single Dose of NFC-1 400 mg Receives: Drug: NFC-1 400 mg |
| NFC-1 800 mg | Experimental | Single Dose of NFC-1 800 mg Receives: Drug: NFC-1 800 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma drug concentration-time curve (AUC0-24h)
Measured: 24 hours of sample collections
Area under the plasma drug concentration-time curve (AUC0-inf)
Measured: 28 hours of sample collections
Area under the plasma drug concentration-time curve (AUClast)
Measured: 28 hours of sample collections
Terminal Half Life (T½ ) of NFC-1
Measured: 28 hours of sample collections
Maximum Observed Plasma Concentration (Cmax)
Measured: 28 hours of sample collections
Time to Maximum Observed Plasma Concentration (Tmax)
Measured: 28 hours of sample collections
Apparent first order elimination rate constant (kel)
Measured: 28 hours of sample collections
Apparent oral clearance adjusted for bioavailability (CL/F) of NFC-1
Measured: 28 hours of sample collections
Apparent volume of distribution adjusted for bioavailability (Vz/F) of NFC-1
Measured: 28 hours of sample collections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study start7 Jan 2017
- Primary completion26 Feb 2017
- Study completion6 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With HyperactivityStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aevi Genomic Medicine, LLC, a Cerecor company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006367
- Sponsor's protocol ID
- MDGN-NFC1-ADHD-101
- Status last verified
- Mar 2017
- First submitted
- 22 Dec 2016
- Last updated
- 6 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Glessner JT, Khan ME, Chang X, Liu Y, Otieno FG, Lemma M, Slaby I, Hain H, Mentch F, Li J, Kao C, Sleiman PMA, March ME, Connolly J, Hakonarson H. Rare recurrent copy number variations in metabotropic glutamate receptor interacting genes in children with neurodevelopmental disorders. J Neurodev Disord. 2023 Apr 29;15(1):14. doi: 10.1186/s11689-023-09483-z.
PubMed 37120522Slaby I, Hain HS, Abrams D, Mentch FD, Glessner JT, Sleiman PMA, Hakonarson H. An electronic health record (EHR) phenotype algorithm to identify patients with attention deficit hyperactivity disorders (ADHD) and psychiatric comorbidities. J Neurodev Disord. 2022 Jun 11;14(1):37. doi: 10.1186/s11689-022-09447-9.
PubMed 35690720
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single Ascending Dose, Pharmacokinetic and Tolerability Study of NFC-1 in Children and Adolescents (Ages 6-17 Years) With Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT03006367
- Acronym / sponsor ID
- MDGN-NFC1-ADHD-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Aevi Genomic Medicine, LLC, a Cerecor companyIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2017 (actual)
- Primary completion
- 26 Feb 2017 (actual)
- Study completion
- 6 Mar 2017 (actual)
- First posted
- 30 Dec 2016 (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 open-label, single ascending dose, pharmacokinetic, and tolerability study of NFC-1 in Children and Adolescents (Ages 6-17 Years) with ADHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NFC-1 100 mg | Experimental | Drug: NFC-1 100 mgSingle Dose of NFC-1 100 mg |
| NFC-1 200 mg | Experimental | Drug: NFC-1 200 mgSingle Dose of NFC-1 200 mg |
| NFC-1 400 mg | Experimental | Drug: NFC-1 400 mgSingle Dose of NFC-1 400 mg |
| NFC-1 800 mg | Experimental | Drug: NFC-1 800 mgSingle Dose of NFC-1 800 mg |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Subject and parent/legally authorized representative (LAR) are able to speak English fluently and have provided written informed consent, and assent (as applicable) for this study.
- Subject is 6 to 17 years inclusive at the time of consent/assent.
- Subject is male, female of non-childbearing potential or non-pregnant, non-lactating female of childbearing potential who agrees to comply with any applicable contraceptive requirements 2 weeks prior to administration of IP and throughout the study.
- Subject meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for a primary diagnosis of ADHD based on a M.I.N.I. International Neuropsychiatric Interview.
- Subject is considered "healthy". Healthy status is defined by absence of evidence of any active or chronic disease other than their ADHD following a detailed medical and surgical history, a complete physical examination.
Key exclusion criteria (11 listed)
- Subject has a history of any hematological, hepatic, respiratory, cardiovascular, renal, neurological, or psychiatric disease, gall bladder removal, or current or recurrent disease other than their ADHD.
- Subject has a current or relevant history of physical or psychiatric illness, or any medical disorder that may require treatment.
- Subject has a current, controlled or uncontrolled, comorbid psychiatric diagnosis with significant symptoms.
- Subject is considered a suicide risk in the opinion of the investigator, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation.
- Subject has used an investigational product, been enrolled in a clinical study including vaccines, or had any changes in eating habits, within 30 days prior to the first dose of investigational product.
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 |
|---|---|---|
| NFC-1 100 mgAlso: AEVI-001, MDGN-001 | Drug | NFC-1 100 mg |
| NFC-1 200 mgAlso: AEVI-001, MDGN-001 | Drug | NFC-1 200 mg |
| NFC-1 400 mgAlso: AEVI-001, MDGN-001 | Drug | NFC-1 400 mg |
| NFC-1 800 mgAlso: AEVI-001, MDGN-001 | Drug | NFC-1 800 mg |
Primary outcome
Area under the plasma drug concentration-time curve (AUC0-24h)
Time frame: 24 hours of sample collections
Area under the plasma drug concentration-time curve (AUC0-inf)
Time frame: 28 hours of sample collections
Area under the plasma drug concentration-time curve (AUClast)
Time frame: 28 hours of sample collections
Terminal Half Life (T½ ) of NFC-1
Time frame: 28 hours of sample collections
Maximum Observed Plasma Concentration (Cmax)
Time frame: 28 hours of sample collections
Time to Maximum Observed Plasma Concentration (Tmax)
Time frame: 28 hours of sample collections
Apparent first order elimination rate constant (kel)
Time frame: 28 hours of sample collections
Apparent oral clearance adjusted for bioavailability (CL/F) of NFC-1
Time frame: 28 hours of sample collections
Apparent volume of distribution adjusted for bioavailability (Vz/F) of NFC-1
Time frame: 28 hours of sample collections
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 6 Jul 2021.
- Derived from this study: PubMed 37120522Glessner JT, Khan ME, Chang X, Liu Y, Otieno FG, Lemma M, Slaby I, Hain H, Mentch F, Li J, Kao C, Sleiman PMA, March ME, Connolly J, Hakonarson H. Rare recurrent copy number variations in metabotropic glutamate receptor interacting genes in children with neurodevelopmental disorders. J Neurodev Disord. 2023 Apr 29;15(1):14. doi: 10.1186/s11689-023-09483-z.
- Derived from this study: PubMed 35690720Slaby I, Hain HS, Abrams D, Mentch FD, Glessner JT, Sleiman PMA, Hakonarson H. An electronic health record (EHR) phenotype algorithm to identify patients with attention deficit hyperactivity disorders (ADHD) and psychiatric comorbidities. J Neurodev Disord. 2022 Jun 11;14(1):37. doi: 10.1186/s11689-022-09447-9.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NFC-1 100 mg, NFC-1 200 mg and NFC-1 400 mg in people with Attention Deficit Disorder With Hyperactivity, run by Aevi Genomic Medicine, LLC, a Cerecor company at 3 sites 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 6 inclusion and 11 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 6 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Area under the plasma drug concentration-time curve (AUC0-24h) (time frame: 24 hours of sample collections). The study lists 9 primary outcomes in all. 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 NCT03006367, which also lists 2 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 6 Jul 2021.