A Phase 1 interventional study of ORIC-114 in Food Effect in Healthy Participants, sponsored by ORIC Pharmaceuticals. Completed at 2 sites in Australia. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-19.
Sponsored by ORIC Pharmaceuticals · Phase 1, Interventional, and Other
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.
Exclusion Criteria:
30 mg ORIC-114 (3 x 10 mg tablets) administered at Hour 0 on Day 1 under fasting conditions.
Drug: ORIC-114
30 mg ORIC 114 (3 x 10 mg tablets) administered at Hour 0 on Day 1, 30 minutes after the start of a meal.
Drug: ORIC-114
xx mg ORIC-114 (n x 10 mg tablets) administered at Hour 0 on Day 1 under fasting conditions.
Drug: ORIC-114
xx mg ORIC 114 (n x 10 mg tablets) administered at Hour 0 on Day 1, 30 minutes after the start of a meal.
Drug: ORIC-114
Food effect healthy subjects
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
Plan to share: No
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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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ORIC Pharmaceuticals