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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05712681
• Other study ID #: JP-1366-105
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: February 2023
• Est. completion date: May 2023

Study information

• Verified date: January 2023
• Source: Onconic Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: May 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• JP-1366 20mg tablet
T : JP-1366 20mg tablet after the meal
• JP-1366 20mg tablet
R : JP-1366 20mg tablet under fasting condition

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Central	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Onconic Therapeutics Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of JP-1366		Pre-dose(0 hour) and up to 34 hours in each period
Primary	AUClast of JP-1366		Pre-dose(0 hour) and up to 34 hours in each period
Secondary	Gastric pH		Pre-dose(0 hour) up to 24 hours after Investigational product administration