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NCT Number: NCT06012721

Effect of Food on the Pharmacokinetics of ORIC-114

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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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nucleus Network Pty Ltd., 235 Ryrie St, Geelong, Victoria, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy, adult, male or female (of nonchildbearing potential only), 18-55 years of age
  • Continuous nonsmoker who has not used nicotine and tobacco containing products for at least 30 days
  • Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2
  • Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, and ECGs, as deemed by the PI or designee
  • Able to swallow multiple tablets.

Exclusion criteria

  • Mentally or legally incapacitated or has significant emotional problems
  • History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
  • History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing.
  • History or presence of clinically significant GI disorder (
  • Female subjects of childbearing potential.
  • Positive urine drug screen or alcohol breath test results
  • Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
  • Lactose intolerant.

Treatment and study plan

ORIC-114

Drug

Food effect healthy subjects

Primary outcomes

  1. Maximum plasma concentration (Cmax)

    Time frame: 14 days

    To evaluate the effect of food on the single dose PK of ORIC-114 tablet formulation

  2. Time of maximum observed concentration (Tmax)

    Time frame: 14 days

    Food Effect: PK of ORIC-114 tablet

  3. Area under the curve (AUC)

    Time frame: 14 days

    Food Effect: PK of ORIC-114 tablet

  4. Apparent plasma terminal elimination half-life (t1/2)

    Time frame: 14 days

    Food Effect: PK of ORIC-114 tablet

Secondary outcomes

  1. Number of subjects with Treatment Emergent Adverse Effect

    Time frame: 30 days

    Assessed by NCI CTCAE v5.0

Sponsors and collaborators

Lead sponsor

ORIC Pharmaceuticals

Industry

Registry information

Official study title

A Phase 1, Randomized, Open-Label, Crossover Study Evaluating the Effect of Food on the Pharmacokinetics of ORIC-114 Tablet Formulation in Healthy Subjects

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 25, 2023
Registry last updated
Jan 19, 2024

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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