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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: JP-1366 20mg tablet; Drug: JP-1366 20mg tablet

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Asan Medical Central

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Sequence 1; T → Washout period(7-14days) → R	Drug: JP-1366 20mg tablet; T : JP-1366 20mg tablet after the meal; Drug: JP-1366 20mg tablet; R : JP-1366 20mg tablet under fasting condition
EXPERIMENTAL: Sequence 2; R → Washout period(7-14days) → T	Drug: JP-1366 20mg tablet; T : JP-1366 20mg tablet after the meal; Drug: JP-1366 20mg tablet; R : JP-1366 20mg tablet under fasting condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Gastric pH	Pre-dose(0 hour) up to 24 hours after Investigational product administration

Collaborators and Investigators

• Sponsor: Onconic Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2023
• Primary Completion (ANTICIPATED): April 1, 2023
• Study Completion (ANTICIPATED): May 1, 2023

Study Registration Dates

• First Submitted: January 13, 2023
• First Submitted That Met QC Criteria: January 25, 2023
• First Posted (ACTUAL): February 3, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 3, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: JP-1366-105

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No