NCT05712681

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Mar 2023

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 3, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

March 29, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2023

Completed
Last Updated

August 26, 2024

Status Verified

January 1, 2023

Enrollment Period

1 month

First QC Date

January 13, 2023

Last Update Submit

August 22, 2024

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Gastric pH

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

Study Arms (2)

Sequence 1

EXPERIMENTAL

T → Washout period(7-14days) → R

Drug: JP-1366 20mg tablet

Sequence 2

EXPERIMENTAL

R → Washout period(7-14days) → T

Drug: JP-1366 20mg tablet

Interventions

JP-1366 20mg tabletDRUG

T : JP-1366 20mg tablet after the meal

Sequence 1Sequence 2

Eligibility Criteria

Age19 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Central

Seoul, South Korea

Location

MeSH Terms

Interventions

Tablets

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2023

First Posted

February 3, 2023

Study Start

March 29, 2023

Primary Completion

May 4, 2023

Study Completion

May 18, 2023

Last Updated

August 26, 2024

Record last verified: 2023-01

Locations

KR(1)