Clinical Trial to Evaluate the Safety and Pharmacokinetics of JP-1366 in Healthy Adult Volunteers

Phase I Study to Evaluate the Safety and Pharmacokinetics of JP-1366 in Healthy Adult Volunteers

To evaluate the safety and the pharmacokinetics of the JP-1366 20 mg tablet and capsule oral administration in healthy adult volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: JP-1366 20mg tablet; Drug: JP-1366 20mg capsule

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Yangji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Subjects ≥ 19 years of age
2. Subjects who weigh ≥ 50 kg (or ≥ 45 kg in the case of females) with body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 30.0 kg/m2

Exclusion Criteria:

1. Subjects with clinically significant diseases or a medical history related to the digestive system, cardiovascular system, endocrine system, respiratory system, blood and tumor, infections diseases, kidney and urinary system, psychiatric and nervous system, musculoskeletal system, immune system, otorhinolaryngology, skin, and ophthalmological system
2. Subjects who have a history of gastrointestinal surgery (except simple appendectomy or herniotomy) or have gastrointestinal disorders that may affect the absorption of the drug
3. Subjects who received inducers or inhibitors of drug metabolizing enzymes
4. Subjects who have hypersensitivity to this drug, ingredients of this drug, or benzimidazoles, or have a medical history thereof
5. Patients receiving drugs containing atazanavir, nelfinavir, or rilpivirine
6. Subjects who are judged ineligible to participate in this study by the principal investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence A; R → Washout period(7days) → T	Drug: JP-1366 20mg tablet; T : JP-1366 20mg tablet; Other Names: Zastaprazan 20mg; Drug: JP-1366 20mg capsule; R : JP-1366 20mg capsule; Other Names: Zastaprazan 20mg
Experimental: Sequence B; T → Washout period(7days) → R	Drug: JP-1366 20mg tablet; T : JP-1366 20mg tablet; Other Names: Zastaprazan 20mg; Drug: JP-1366 20mg capsule; R : JP-1366 20mg capsule; Other Names: Zastaprazan 20mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUCt of Zastaprazan(JP-1366 20mg)	Pre-dose(0 hour) and up to 34 hours in each period
Cmax of Zastaprazan(JP-1366 20mg)	Pre-dose(0 hour) and up to 34 hours in each period

Collaborators and Investigators

• Sponsor: Onconic Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2022
• Primary Completion (Actual): October 9, 2022
• Study Completion (Actual): November 9, 2022

Study Registration Dates

• First Submitted: April 3, 2023
• First Submitted That Met QC Criteria: April 3, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 20, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: JP-1366-104

Drug and device information, study documents

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