This is a sequential, randomized, double-blind, placebo-controlled Phase 1 single (SAD) and multiple (MAD) ascending dose study to evaluate the safety, tolerability, and pharmacokinetics (PK) of orally or intravenously administered LTG-001 in healthy male and female participants
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
204
Clinical Research Unit
Christchurch, New Zealand
Evaluate the safety and tolerability of single and multiple ascending oral doses, relative bioavailability and food effect of LTG-001 in healthy subjects
Incidence, severity, seriousness, and causality of treatment-emergent adverse events (TEAEs)
Time frame: Up to 10 days of dosing
Absolute Bioavailability of LTG-001 Following Oral and Intravenous Administration
Absolute bioavailability of LTG-001 will be assessed by comparing systemic exposure following a single oral tablet dose and a single intravenous dose.
Time frame: from admission to completion in the study (35 days)
Safety and Tolerability of Intravenous LTG-001
Safety and tolerability of intravenous LTG-001 will be assessed by the number of participants with treatment-emergent adverse events (TEAEs), changes in clinical laboratory parameters, vital signs, electrocardiograms (ECGs), physical examination findings, and infusion site reactions following intravenous administration.
Time frame: From first intravenous dose through end of study (up to 14 days following intravenous dosing)
To further characterize the PK of LTG-001 in healthy participants
Cmax
Time frame: Up to 10 days of dosing
To further characterize the PK of LTG-001 in healthy participants
Area under the concentration curve from 0 to last (AUC0-last)
Time frame: Up to 10 days of dosing
To further characterize the PK of LTG-001 in healthy participants
Area under the concentration curve from 0 to infinity (AUC0-inf)
Time frame: Up to 10 days of dosing
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To further characterize the PK of LTG-001 in healthy participants
Time of the maximum observed plasma concentration (tmax)
Time frame: Up to 10 days of dosing
To further characterize the PK of LTG-001 in healthy participants
Elimination rate constant (λz)
Time frame: Up to 10 days of dosing
To further characterize the PK of LTG-001 in healthy participants
Terminal elimination half-life (t1⁄2)
Time frame: Up to 10 days of dosing
To further characterize the PK of LTG-001 in healthy participants
Concentration at 12 hours (C12)
Time frame: Up to 10 days of dosing
To further characterize the PK of LTG-001 in healthy participants
Oral clearance (CL/F)
Time frame: Up to 10 days of dosing
To further characterize the PK of LTG-001 in healthy participants
Oral apparent volume of distribution (Vz/F)
Time frame: Up to 10 days of dosing