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CompletedNCT05712681Updated Aug 26, 2024

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

A Phase 1 interventional study of JP-1366 20mg tablet and JP-1366 20mg tablet in Healthy, sponsored by Onconic Therapeutics Inc.. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-26.

Sponsored by Onconic Therapeutics Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
19 Years to 45 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Onconic Therapeutics Inc. is the lead sponsor of 18 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Sequence 1

    T → Washout period(7-14days) → R

    Drug: JP-1366 20mg tablet

  • Experimental
    Sequence 2

    R → Washout period(7-14days) → T

    Drug: JP-1366 20mg tablet

Interventions

  • DrugJP-1366 20mg tablet

    T : JP-1366 20mg tablet after the meal

  • DrugJP-1366 20mg tablet

    R : JP-1366 20mg tablet under fasting condition

06

What researchers measure

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

07

Study locations

1 site
  • Asan Medical Central
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05712681
Lead sponsor
Onconic Therapeutics Inc.
Responsible party
Sponsor
First posted
Feb 3, 2023
Start date
Mar 29, 2023
Primary completion
May 4, 2023
Completion
May 18, 2023
Last update
Aug 26, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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