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This an open label study to assess the pharmacokinetics of CT1812 in normal healthy volunteers.
Open label study to assess PK in 36 older healthy volunteers. Subjects will be screened 35 days prior dose to determine eligibility. On day -1 subjects will be admitted to the clinical research unit and on day 1 will be randomized to receive one of the following doses: 150 mg BID, 150 mg QD or 300 mg QD in the fed state. Subjects will be confined in the Clinical Research Unit where they will continue to receive study drug and complete safety assessments, PK and CSF draws, until day 16 when they will be discharged.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 150 mg QD | Experimental | CT1812 150 mg QD |
|
| 150 mg BID | Experimental | CT1812 150 mg BID |
|
| 300 mg QD | Experimental | CT1812 300 mg QD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT1812 | Drug | Study Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) in plasma | Cmax: Maximum observed plasma concentration occurring at Tmax | Day 13 and 15. |
| Pharmacokinetics (PK) in plasma | Tmax: The first time to maximum observed concentration sampled during a dosing interval. | Day 13 and 15. |
| Pharmacokinetics (PK) in plasma | Ctau: Concentration at the end of the dosing interval (12 hr for BID group; 24 hr for QD group). | Day 13 and 15. |
| Pharmacokinetics (PK) in plasma | AUC 0-12h: Area under the concentration-time curve (AUC) from time 0 to 12 hours post-dose. | Day 13 and 15. |
| Pharmacokinetics (PK) in plasma | AUC 0-24h: AUC from time 0 to 24 hours post-dose. | Day 13 and 15. |
| Pharmacokinetics (PK) in plasma | AUC 0-last: AUC from time 0 to the time of the last measurable concentration at 48 and 72 hours as applicable. | Day 13 and 15. |
| Pharmacokinetics (PK) in plasma | AUC 0-inf: Area under the concentration-time curve (AUC) from time 0 extrapolated to infinity, calculated using the observed value of the last non-zero concentration. | Day 13 and 15. |
| Pharmacokinetics (PK) in plasma |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Caggiano, MD | Cognition Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Accel Clinical Research | DeLand | Florida | 32720 | United States |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Open Label Study
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AUC_%Extrap: Percent of AUC0-inf contributed by extrapolation beyond AUC0-last. |
| Day 13 and 15. |
| Pharmacokinetics (PK) in plasma | λz : Terminal elimination phase rate constant. | Day 13 and 15. |
| Pharmacokinetics (PK) in plasma | t½: Terminal phase half-life. | Day 13 and 15. |
| Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF). | Cmax - Maximum observed plasma concentration occurring at Tmax. | Day 13 and 15. |
| Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF). | Tmax -The first time to maximum observed concentration sampled during a dosing interval. | Day 13 and 15. |
| Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF). | Cavg,ss - Average plasma concentration at steady-state interval. | Day 13 and 15. |
| Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF). | Ctau-Concentration at the end of the dosing interval (12 hr for BID group; 24 hr for QD group). | Day 13 and 15. |
| Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF). | Fluctuation (%) - Fluctuation (%) between maximum and minimum concentrations over the steady-state dosing interval. | Day 13 and 15. |
| Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF). | AUC-0-tau - Area under the concentration-time curve from time 0 to the end of the dosing interval (0-12 for the BID group; 0 - 24 for the QD groups) . | Day 13 and 15. |
| Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF). | λz- Terminal elimination phase rate constant | Day 13 and 15. |
| Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF). | t½ - Terminal phase half-life | Day 13 and 15. |
| Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF). | AUCcum- Accumulation ratio in AUC, calculated as AUC0-tau,ss/AUC0-tau,D1 | Day 13 and 15. |
| Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF). | Ctau,cum- Accumulation ratio in Ctau, calculated as Ctau,ss/Ctau,D1 | Day 13 and 15. |
| Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF). | Cmax,cum - Accumulation ratio in Cmax, calculated as Cmax,ss/Cmax,D1 | Day 13 and 15. |
| Pharmacokinetics (PK) in Cerebrospinal Fluid (CSF)- CSF/plasma ratio | CSF/plasma ratio - Pre-dose on Day 13 and 3h (±15 min) post-dose on Day 15 | Day 13 and 15. |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |