NCT05814809

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Sep 2022

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

Study Start

First participant enrolled

September 30, 2022

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
Last Updated

April 20, 2023

Status Verified

April 1, 2023

Enrollment Period

9 days

First QC Date

April 3, 2023

Last Update Submit

April 17, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Sequence A

EXPERIMENTAL

R → Washout period(7days) → T

Drug: JP-1366 20mg tabletDrug: JP-1366 20mg capsule

Sequence B

EXPERIMENTAL

T → Washout period(7days) → R

Drug: JP-1366 20mg tabletDrug: JP-1366 20mg capsule

Interventions

JP-1366 20mg tabletDRUG

T : JP-1366 20mg tablet

Also known as: Zastaprazan 20mg
Sequence ASequence B
JP-1366 20mg capsuleDRUG

R : JP-1366 20mg capsule

Also known as: Zastaprazan 20mg
Sequence ASequence B

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects ≥ 19 years of age
  • 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

You may not qualify if:

  • 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
  • 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
  • Subjects who received inducers or inhibitors of drug metabolizing enzymes
  • Subjects who have hypersensitivity to this drug, ingredients of this drug, or benzimidazoles, or have a medical history thereof
  • Patients receiving drugs containing atazanavir, nelfinavir, or rilpivirine
  • Subjects who are judged ineligible to participate in this study by the principal investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yangji Hospital

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

April 3, 2023

First Posted

April 18, 2023

Study Start

September 30, 2022

Primary Completion

October 9, 2022

Study Completion

November 9, 2022

Last Updated

April 20, 2023

Record last verified: 2023-04

Locations

KR(1)