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

Sponsor
Onconic Therapeutics Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05712681
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
2.9
Anticipated Duration (Months)
8.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: JP-1366 20mg tablet
  • Drug: JP-1366 20mg tablet
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Cmax of JP-1366 [Pre-dose(0 hour) and up to 34 hours in each period]

  2. AUClast of JP-1366 [Pre-dose(0 hour) and up to 34 hours in each period]

Secondary Outcome Measures

  1. Gastric pH [Pre-dose(0 hour) up to 24 hours after Investigational product administration]

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 45 Years
Sexes Eligible for Study:
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:

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Asan Medical Central Seoul Korea, Republic of

Sponsors and Collaborators

  • Onconic Therapeutics Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Onconic Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT05712681
Other Study ID Numbers:
  • JP-1366-105
First Posted:
Feb 3, 2023
Last Update Posted:
Feb 3, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 3, 2023