A randomized, 2-part, 2-sequence, 2-period, open-label, crossover study evaluating the effect of food on the pharmacokinetics (PK) of ORIC-114 tablet formulation in healthy adult subjects.
The study will be performed in two parts. Part 1 will assess the effect of food at a lower dose of ORIC-114 to first ascertain the degree of food effect (if any) on ORIC-114 exposure as a way to ensure the safety of the participating subjects. Part 2 will further assess the food effect at a higher dose of ORIC-114. If the preliminary Part 1 results clearly show no food effect, Part 2 may not need to be conducted upon assessment by the Sponsor. If Part 2 is conducted, the dose of ORIC-114 will be selected within the anticipated efficacious clinical dose range based on results from Part 1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
32
Food effect healthy subjects
Nucleus Network Pty Ltd., 235 Ryrie St
Geelong, Victoria, Australia
Nucleus Network Pty Ltd., Level 5, Burnet Tower, 89 Commercial Rd
Melbourne, Victoria, Australia
Maximum plasma concentration (Cmax)
To evaluate the effect of food on the single dose PK of ORIC-114 tablet formulation
Time frame: 14 days
Time of maximum observed concentration (Tmax)
Food Effect: PK of ORIC-114 tablet
Time frame: 14 days
Area under the curve (AUC)
Food Effect: PK of ORIC-114 tablet
Time frame: 14 days
Apparent plasma terminal elimination half-life (t1/2)
Food Effect: PK of ORIC-114 tablet
Time frame: 14 days
Number of subjects with Treatment Emergent Adverse Effect
Assessed by NCI CTCAE v5.0
Time frame: 30 days
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