This is a two-part study. Part A consists of two different IkT-148009-201 solid dosage formulations that are being evaluated to determine their steady-state pharmacokinetic profile. Part B is a drug-drug interaction (DDI) study focused on evaluating the impact of a strong CYP3A inhibitor on the preferred dosage determined in part A.
This is a two-part study. Part A is a single dose (7-day) study to determine the safety, tolerability and pharmacokinetics (PK) of two different tablet formulations of IkT-148009 in older and elderly healthy subjects. Subjects in each cohort of the study will be admitted to the unit the day prior to the expected day of dosing and will be confined to the unit for approximately 12 days. Each cohort will consist of six (6) subjects who will receive treatment with one of two formulations of IkT- 148009 film-coated tablets at a single dose once daily for 7 days. Part B is a Drug-Drug Interaction (DDI) study to determine the effect of itraconazole on the pharmacokinetics of IkT-148009. Subjects in each cohort of the study will be admitted to the unit the day prior to the expected day of dosing in each period and will be confined to the unit for approximately 6 days in period 1 and 10 days in period 2. Up to eight (8) subjects will be evaluated in a two-period design in the fed state. In Period 1, the 50 mg film-coated IkT-148009 tablet dose pharmacokinetics will be measured, followed by a 7-day washout. In Period 2, the same eight subjects will first be administered a 200 mg once daily capsule dose of itraconazole for four days. On Period 2 day 4 subjects will take a single 200 mg capsule dose of itraconazole, followed one hour later by a 50 mg film-coated tablet dose of IkT-148009.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
8
100mg wet tablet formulation
2 100mg capsules
100mg dry tablet formulation
Celerion
Lincoln, Nebraska, United States
Patient Safety
Changes in vital sign measurements including HR and blood pressure.
Time frame: Through study completion, an average of 17 days
Patient Safety
Changes in clinical laboratory data consisting of CBC, Serum Chemistry, FSH
Time frame: Through study completion, an average of 17 days
Patient Safety
Electrocardiogram \[ECG\] parameters of ventricular rate, RR or PR interval, QRS complex, and QTcF interval.
Time frame: Through study completion, an average of 17 days
Patient Safety
C-SSRS assessment values.
Time frame: Through study completion, an average of 17 days
Pharmacokinetic parameters in the absence or presence of itraconazole:
Pharmacokinetic parameters: • Area under the concentration-time curve from time zero to 96 hours (AUC0-∞)
Time frame: Through study completion, an average of 17 days
Pharmacokinetic parameters in the absence or presence of itraconazole:
Pharmacokinetic parameters: • Maximum plasma concentration (Cmax)
Time frame: Through study completion, an average of 17 days
Pharmacokinetic parameters in the absence or presence of itraconazole:
Pharmacokinetic parameters: • Area under the concentration-time curve from time zero to last time point (AUC0-last)
Time frame: Through study completion, an average of 17 days
Assess the pharmacokinetics (PK) of IkT-148009
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50mg wet tablet formulation
Pharmacokinetic parameters: • Area under the concentration-time curve from time zero to 96 hours (AUC0-∞)
Time frame: Through study completion, an average of 17 days
Assess the pharmacokinetics (PK) of IkT-148009
Pharmacokinetic parameters: • Maximum plasma concentration (Cmax)
Time frame: Through study completion, an average of 17 days
Assess the pharmacokinetics (PK) of IkT-148009
Pharmacokinetic parameters: • Area under the concentration-time curve from time zero to last time point (AUC0-last)
Time frame: Through study completion, an average of 17 days
Patient Tolerability
Adverse event reporting
Time frame: Through study completion, an average of 17 days