This study comprised of 2 parts, Part A and Part B. Part B will only be conducted if the relative bioavailability of the tablet formulation was at least 70% of the capsule formulation.
Part A is a randomized, single-dose, 4-period, 4-way cross-over study to evaluate the effect of food on the TP 3654 capsule and assess the relative bioavailability of the TP-3654 capsule versus tablet formulations. Following a screening period of up to 28 days, eligible participants will be admitted to the clinical research unit (CRU) on Day -1. Participants will fast overnight from Day -1 to Day 1. On Day 1, participants will be randomly assigned to a treatment sequence, and they will receive TP-3654 per their assigned sequence. Part B is a randomized, single-dose, 3-period, 3-way cross-over study to evaluate the effect of food on the PK of the TP-3654 tablet formulation. Following a screening period of up to 28 days, eligible participants will be admitted to the CRU on Day -1. As with Part A, participants will fast overnight from Day -1 to Day 1. On Day 1, they will be randomly assigned to a treatment sequence, and they will receive TP-3654 per their assigned sequence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
12
TP 3654 is an investigational orally delivered drug
Frontage Investigative Site
Secaucus, New Jersey, United States
Part A - The maximum concentration (Cmax) of TP-3654 in a capsule formulation
Time frame: 2 weeks
Part A - The area under the curve (AUC) of TP-3654 in a capsule formulation
Time frame: 2 weeks
Part A - Ratio of Peak Plasma Concentration (Cmax) of TP-3654 tablet versus TP-3654 capsule under fasted conditions
Time frame: 2 weeks
Part B - The maximum concentration (Cmax) of TP-3654 in a tablet formulation
Time frame: 2 weeks
Number of participants with Treatment Emergent Adverse Events (TEAE)
TEAEs will be monitored from first dose to 30 days after the last dose
Time frame: 6 weeks
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