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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Single-sequence drug-drug interaction study to determine the effect of CT1812 (560 mg) once daily on the pharmacokinetics of tolbutamide
Single-sequence drug-drug interaction study to determine the effect of CT1812 (560 mg) once daily on the pharmacokinetics of dextromethorphan
Jasper Clinic
Kalamazoo, Michigan, United States
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
Time frame: 10 days
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Single-sequence drug-drug interaction study to determine the effect of CT1812 (560 mg) once daily on the pharmacokinetics of omeprazole
Single-sequence drug-drug interaction study to determine the effect of CT1812 (560 mg) once daily on the pharmacokinetics of midazolam