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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: JP-1366 20mg tablet; Drug: JP-1366 20mg capsule

• Registration Number: NCT05814809
• Lead Sponsor: Onconic Therapeutics Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-30
• Primary Completion: 2022-10-09
• Study Completion: 2022-11-09
• Status Verified: 2023-04
• Study First Submitted: 2023-04-03
• Study First Submitted QC: 2023-04-03
• Last Update Submitted: 2023-04-17
• Study First Posted: 2023-04-18
• Last Update Posted: 2023-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence B	JP-1366 20mg capsule	T → Washout period(7days) → R
Sequence B	JP-1366 20mg tablet	T → Washout period(7days) → R
Sequence A	JP-1366 20mg tablet	R → Washout period(7days) → T
Sequence A	JP-1366 20mg capsule	R → Washout period(7days) → T

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Yangji Hospital; 🇰🇷 Seoul, Korea, Republic of