This is a Phase 1 study in older adult or elderly healthy volunteer subjects to measure the safety, tolerability and pharmacokinetic (PK) profile of IkT-148009 capsules given as multiple capsules.
This is a Phase 1 study in older adult or elderly healthy volunteer subjects to measure the safety, tolerability and pharmacokinetic (PK) profile of IkT-148009 capsules given as multiple capsules. This is a single arm study with subjects to treatment with IkT-148009 only. The study will consist of a total of up to 15 visits over a period of up to 29 days prior to dosing, 7 days of dosing and 14 days of follow up. Subjects will receive a single daily dose of study drug with a meal for a period of up to 7 days. A full breakfast must be consumed prior to receiving the dose study drug. Subjects will be confined to the unit for approximately 12 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
4 50mg capsules
Celerion
Lincoln, Nebraska, United States
Participant Safety
Adverse event reporting
Time frame: Through study completion, an average of 50 days
Participant Safety - vital signs
Changes in vital sign measurements including HR and blood pressure.
Time frame: Through study completion, an average of 50 days
Participant Safety - clinical lab values
Changes in clinical laboratory data consisting of CBC, Serum Chemistry, FSH.
Time frame: Through study completion, an average of 50 days
Participant Safety
Electrocardiogram \[ECG\] parameters of ventricular rate, RR or PR interval, QRS complex, and QTcF interval.
Time frame: Through study completion, an average of 50 days
Participant Safety
C-SSRS assessment values.
Time frame: Through study completion, an average of 50 days
Participant Tolerability
Percent completers
Time frame: Through study completion, an average of 50 days
Assess the pharmacokinetics (PK) of IkT-148009
Pharmacokinetic parameters: • Area under the concentration-time curve from time zero to 96 hours (AUC0-∞)
Time frame: Through study completion, an average of 50 days
Assess the pharmacokinetics (PK) of IkT-148009
Pharmacokinetic parameters: • Maximum plasma concentration (Cmax)
Time frame: Through study completion, an average of 50 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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 50 days