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This is Phase 1, single-center, open-label, single-sequence drug-drug interaction study to determine the effect of CT1812 (560 mg) once daily on the pharmacokinetics of 4 probe drugs (tolbutamide, midazolam, dextromethorphan and omeprazole).
This is Phase 1, single-center, open-label, single-sequence drug-drug interaction study to determine the effect of CT1812 (560 mg) once daily on the pharmacokinetics of 4 probe drugs (tolbutamide, midazolam, dextromethorphan and omeprazole).
Each subject will qualify for entry into the study within 35 days before admission to the clinical unit. Subjects will check into the clinical unit on Day -3 for baseline assessments. Each subject will receive a single dose of each of the probe drugs on Day -2 as a 'cocktail'. A single dose of CT1812 and each of the probe drugs will be co-administered on Day 6. On Days 1 through 5, subjects will receive a single daily dose of CT1812.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Treatment- CT1812 560 mg | Experimental | Single-sequence drug-drug interaction study to determine the effect of CT1812 (560 mg) once daily on the pharmacokinetics of 4 probe drugs (tolbutamide, midazolam, dextromethorphan and omeprazole) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT1812 | Drug |
| ||
| tolbutamide |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma-concentration time curve of CT1812 (Day 6) compared to the baseline values (Day -2) | Single dose (Day -2 and Day 6) pharmacokinetic parameter Area under the plasma-concentration time curve | 10 days |
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Inclusion Criteria:
Willing and able to provide written informed consent prior to initiation of any study-related procedures.
Men and women ≥ 18 and ≤ 55 years of age
In good health as determined by medical history, physical exam, laboratory examinations, ECG, and vital signs
BMI between 18 and 35 kg/m2, inclusive
Have a normal 12-lead electrocardiogram, without any clinically significant abnormalities of rate, rhythm or conduction
Non-smokers; defined as not having smoked in the previous 6 months
Women who are neither pregnant (negative pregnancy test) nor nursing, and are either:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alyssa Galley | Cognition Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jasper Clinic | Kalamazoo | Michigan | 49007 | United States |
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| ID | Term |
|---|---|
| D014044 | Tolbutamide |
| D003915 | Dextromethorphan |
| D009853 | Omeprazole |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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This is Phase 1, single-center, open-label, single-sequence drug-drug interaction study to determine the effect of CT1812 (560 mg) once daily on the pharmacokinetics of 4 probe drugs (tolbutamide, midazolam, dextromethorphan and omeprazole)
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Single-sequence drug-drug interaction study to determine the effect of CT1812 (560 mg) once daily on the pharmacokinetics of tolbutamide |
|
| dextromethorphan | Drug | Single-sequence drug-drug interaction study to determine the effect of CT1812 (560 mg) once daily on the pharmacokinetics of dextromethorphan |
|
| Omeprazole | Drug | Single-sequence drug-drug interaction study to determine the effect of CT1812 (560 mg) once daily on the pharmacokinetics of omeprazole |
|
| midazolam | Drug | Single-sequence drug-drug interaction study to determine the effect of CT1812 (560 mg) once daily on the pharmacokinetics of midazolam |
|
| D013453 |
| Sulfonylurea Compounds |
| D014508 | Urea |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |