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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: JP-1366 20mg tablet

• Registration Number: NCT05712681
• Lead Sponsor: Onconic Therapeutics Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-13
• Study First Submitted QC: 2023-01-25
• Study First Posted: 2023-02-03
• Study Start: 2023-03-29
• Primary Completion: 2023-05-04
• Study Completion: 2023-05-18
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1	JP-1366 20mg tablet	T → Washout period(7-14days) → R
Sequence 2	JP-1366 20mg tablet	R → Washout period(7-14days) → T

Primary Outcome Measures

Name	Time	Method
Cmax of JP-1366	Pre-dose(0 hour) and up to 34 hours in each period
AUClast of JP-1366	Pre-dose(0 hour) and up to 34 hours in each period

Secondary Outcome Measures

Name	Time	Method
Gastric pH	Pre-dose(0 hour) up to 24 hours after Investigational product administration

Trial Locations

Locations (1)

Asan Medical Central; 🇰🇷 Seoul, Korea, Republic of