This is a first-in-human, randomized, double-blind, placebo-controlled Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of orally administered LTG-321 in healthy male and female participants 18 to 55 years of age. The study will be conducted in New Zealand. The study also includes a randomized, double-blind, placebo-controlled, within-participant crossover evaluation of pain tolerance using a cold pressor test in healthy male participants 18 to 55 years of age. In addition, a randomized, open-label, crossover Food Effect cohort will evaluate the impact of a high-fat meal on the pharmacokinetics of LTG-321 following single oral doses in the fed and fasted state.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
236
active investigational drug
Placebo-to-match LTG-321
New Zealand Clinical Research
Christchurch, New Zealand
RECRUITINGTo evaluate the Incidence, severity, seriousness, and causality of treatment-emergent adverse events (TEAEs) of single and multiple ascending oral doses of LTG-321 in healthy participants
Incidence, severity, seriousness, and causality of treatment-emergent adverse events (TEAEs)
Time frame: Up to 14 days of dosing
To evaluate the Pain Detection and Tolerance Threshold during Cold Pressor Test of LTG-321 in healthy male participants.
Change from baseline at various individual time points and at various intervals for time to reach pain detection threshold (PDT) and time to reach pain tolerance threshold (PTT), for each dose of LTG-321 vs. placebo.
Time frame: Up to 5 days of dosing
Effect of Food on Pharmacokinetics of LTG-321
Assessment of the effect of a high-fat meal on systemic exposure of LTG-321 following a single oral dose administered under fed and fasted conditions.
Time frame: Up to approximately 48 hours post-dose in each treatment period
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