ORIC-114
DrugFood effect healthy subjects
NCT Number: NCT06012721
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.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Nucleus Network Pty Ltd., 235 Ryrie St, Geelong, Victoria, Australia
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Food effect healthy subjects
Time frame: 14 days
To evaluate the effect of food on the single dose PK of ORIC-114 tablet formulation
Time frame: 14 days
Food Effect: PK of ORIC-114 tablet
Time frame: 14 days
Food Effect: PK of ORIC-114 tablet
Time frame: 14 days
Food Effect: PK of ORIC-114 tablet
Time frame: 30 days
Assessed by NCI CTCAE v5.0
ORIC Pharmaceuticals
Industry
A Phase 1, Randomized, Open-Label, Crossover Study Evaluating the Effect of Food on the Pharmacokinetics of ORIC-114 Tablet Formulation in Healthy Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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