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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NFC-1 100 mg | Experimental | Single Dose of NFC-1 100 mg |
|
| NFC-1 200 mg | Experimental | Single Dose of NFC-1 200 mg |
|
| NFC-1 400 mg | Experimental | Single Dose of NFC-1 400 mg |
|
| NFC-1 800 mg | Experimental | Single Dose of NFC-1 800 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NFC-1 100 mg | Drug |
|
| |
| NFC-1 200 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma drug concentration-time curve (AUC0-24h) | 24 hours of sample collections | |
| Area under the plasma drug concentration-time curve (AUC0-inf) | 28 hours of sample collections | |
| Area under the plasma drug concentration-time curve (AUClast) | 28 hours of sample collections | |
| Terminal Half Life (T½ ) of NFC-1 | 28 hours of sample collections | |
| Maximum Observed Plasma Concentration (Cmax) | 28 hours of sample collections | |
| Time to Maximum Observed Plasma Concentration (Tmax) | 28 hours of sample collections | |
| Apparent first order elimination rate constant (kel) | 28 hours of sample collections | |
| Apparent oral clearance adjusted for bioavailability (CL/F) of NFC-1 | 28 hours of sample collections | |
| Apparent volume of distribution adjusted for bioavailability (Vz/F) of NFC-1 | 28 hours of sample collections |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meridien Research, Inc. | Maitland | Florida | 32751 | United States | ||
| QPS-MRA, LLC (Miami Research Associates) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37120522 | Derived | 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. | |
| 35690720 |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Drug |
|
|
| NFC-1 400 mg | Drug |
|
|
| NFC-1 800 mg | Drug |
|
|
| Miami |
| Florida |
| 33143 |
| United States |
| Center for Psychiatry and Behavioral Medicine | Las Vegas | Nevada | 89128 | United States |
| Slaby 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. |