This is a 2-part Phase 1 cross-over study to assess the effects of food on the pharmacokinetics of PC14586 in healthy volunteers. The pharmacokinetics of PC14586 at a clinically relevant dose in Japanese participants will also be studied.
PC14586 is a first-in-class, oral, small molecule p53 reactivator that is selective for the p53 Y220C mutation. This Phase 1 trial will be conducted in 2 parts (Part 1 - pilot and Part 2 - pivotal) to assess the pharmacokinetics of PC14586 in healthy volunteers including Japanese participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
34
An oral dose of PC14586 will be used in Arms A and B (Part 1) and a different dose will be used for Arms C and D and the Japanese cohort (Part 2).
Parexel Early Phase Clinical Unit - Los Angeles
Glendale, California, United States
Part 1: Effect of a high-fat meal on AUClast
Time frame: 2 months
Part 1: Effect of a high-fat meal on AUC0-inf
Time frame: 2 months
Part 1: Effect of a high-fat meal on the Tmax
Time frame: 2 months
Part 1: Effect of a high-fat meal on the Cmax
Time frame: 2 months
Part 2: Effect of a high-fat meal on the AUC0-last
Time frame: 7 months
Part 2: Effect of a high-fat meal on the AUC0-inf
Time frame: 7 months
Part 2: Effect of a high-fat meal on the Tmax
Time frame: 7 months
Part 2: Effect of a high-fat meal on the Cmax
Time frame: 7 months
Part 1: Treatment emergent adverse events (TEAE)
Time frame: 5 months
Part 1: Clinically relevant changes in: physical examinations, vital signs, clinical laboratory tests, 12-lead triplicate electrocardiogram (ECG)
Time frame: 5 months
Part 2: AUC0-last of PC14586
Time frame: 6 months
Part 2: AUC0-inf of PC14586
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Time frame: 6 months
Part 2: Cmax of PC14586
Time frame: 6 months
Part 2: Tmax of PC14586
Time frame: 6 months
Part 2: The apparent clearance (CL/F) of PC14586
Time frame: 6 months
Part 2: Volume of distribution (Vz/F) of PC14586
Time frame: 6 months
Half-life of PC14586
Time frame: 6 months
Part 2: Incidence of Treatment emergent adverse events (TEAE)
Time frame: 10 months