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Completed

NCT Number: NCT05712681

Clinical Trial to Evaluate Food-Effects on Pharmacokinetics and Pharmacodynamics of Oral Single Dose of JP-1366 Tablet in Healthy Volunteers

To Evaluate Food-Effects on Pharmacokinetics and Pharmacodynamics of Oral single dose of JP-1366 tablet in Healthy volunteers

Completed

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Key information

Conditions

Age range

19 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Asan Medical Central

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • A healthy adult aged between 19 and 45 years old
  • BMI between 18.0kg/m2 and 27.0kg/m2 at the time of screening

Exclusion criteria

  • The subject who has clinically significant disease with liver, endocrine system, immune system, nervous system, kidney, cardiovascular disease, mental disorder, the blood of tumor disease, respiratory system or with history of the disease.
  • The subject who has a history of gastrointestinal disorders(e.g., gastroesophageal reflux disease, gastrospasm, gastritis, gastrointestinal ulcers, Crohn's disease, etc.) or history of gastrointestinal surgery
  • The subject who has an allergic disease(excluding mild allergic rhinitis that does not require administration) or has a history of clinically significant hypersensitivity or adverse reactions to clinical trial drugs or drugs containing the same or other drugs (aspirin, NSAIDs, antibiotics, etc.).
  • The subject who has other clinically significant diseases or history
  • The subject who has a history of drug abuse
  • The subject who cannot withstand the insertion and maintenance of pH catheters

Treatment and study plan

JP-1366 20mg tablet

Drug

T : JP-1366 20mg tablet after the meal

Primary outcomes

  1. Cmax of JP-1366

    Time frame: Pre-dose(0 hour) and up to 34 hours in each period

  2. AUClast of JP-1366

    Time frame: Pre-dose(0 hour) and up to 34 hours in each period

Secondary outcomes

  1. Gastric pH

    Time frame: Pre-dose(0 hour) up to 24 hours after Investigational product administration

Sponsors and collaborators

Lead sponsor

Onconic Therapeutics Inc.

Industry

Registry information

Official study title

A Randomized, Open-label, Crossover Phase 1 Clinical Trial to Evaluate Food-Effects on Pharmacokinetics and Pharmacodynamics of Oral Single Dose of JP-1366 Tablet in Healthy Volunteers

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 3, 2023
Registry last updated
Aug 26, 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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