Stage 1: To assess the safety and tolerability of single-ascending-dose levels of IW-6463 tablets when administered orally to healthy subjects Stage 2: To assess the safety and tolerability of multiple-ascending-dose levels of IW-6463 tablets administered orally to healthy subjects Stage 3: To assess the safety and tolerability of a single dose of IW-6463 when administered to health subjects in fed vs fasted states and explore the effects of food on IW-6463 pharmacokinetics (PK)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
110
IW-6463 Tablet
Matching Placebo Tablet
Centre for Human Drug Research
Leiden, Netherlands
After single ascending doses, number of subjects with treatment-emergent adverse events (TEAEs) in the IW-6463 dose-level cohorts vs the (pooled) placebo group.
Time frame: Up to 9 days
After multiple ascending doses, number of subjects with TEAEs in the IW-6463 dose-level cohorts vs the (pooled) placebo group.
Time frame: Up to 32 days
After a single dose, number of subjects with TEAEs in the fed vs fasted dosing period
Time frame: Up to 28 days
Plasma concentration of IW-6463 after single-dose administration under fed vs fasted conditions
Time frame: Up to 21 days
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