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

NCT ID: NCT05814809

Last Updated: 2023-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-30

Study Completion Date

2022-11-09

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence A

R → Washout period(7days) → T

Group Type EXPERIMENTAL

JP-1366 20mg tablet

Intervention Type DRUG

T : JP-1366 20mg tablet

JP-1366 20mg capsule

Intervention Type DRUG

R : JP-1366 20mg capsule

Sequence B

T → Washout period(7days) → R

Group Type EXPERIMENTAL

JP-1366 20mg tablet

Intervention Type DRUG

T : JP-1366 20mg tablet

JP-1366 20mg capsule

Intervention Type DRUG

R : JP-1366 20mg capsule

Interventions

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JP-1366 20mg tablet

T : JP-1366 20mg tablet

Intervention Type DRUG

JP-1366 20mg capsule

R : JP-1366 20mg capsule

Intervention Type DRUG

Other Intervention Names

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Zastaprazan 20mg Zastaprazan 20mg

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Onconic Therapeutics Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Yangji Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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JP-1366-104

Identifier Type: -

Identifier Source: org_study_id

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