Bowel Diseases, Inflammatory Clinical Trial
Official title:
A Phase 1, Two-Part, Open-Label Study to Assess the Relative Bioavailability of Two TD-1473 Tablet Formulations Under Fasted and Fed Conditions in Healthy Subjects and the Pharmacokinetics of TD-1473 in Healthy Chinese Subjects
This is a Phase 1, 2-part, open-label study. Part A will be a formulation bridging and food effect study in healthy adult subjects. Part B will be an assessment of pharmacokinetics (PK) in healthy adult Chinese subjects.
In study Part A, healthy adult subjects will receive the following treatments in a cross-over design with a ≥10-day washout period between doses: - Treatment A: Single dose of [Tablet A] TD-1473 proposed commercial tablet formulation on Day 1 in a fasted state; - Treatment B: Single dose of [Tablet A] TD-1473 proposed commercial tablet formulation on Day 1 in a fed state; - Treatment C: Single dose of [Tablet B] TD-1473 current clinical tablet formulation on Day 1 in a fasted state; - Treatment D: Single dose of [Tablet B] TD-1473 current clinical tablet formulation on Day 1 in a fed state. In study Part B, healthy adult Chinese subjects will receive Treatment A: Single dose of [Tablet A] TD-1473 proposed commercial tablet formulation on Day 1 in a fasted state. ;
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