Clinical Trial to Evaluate the Safety and Pharmacokinetic... | NCT05814809

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

NCT05814809

Sponsor

Onconic Therapeutics Inc.

Status

Completed

Last Update Posted

Apr 20, 2023Actual

Enrollment

30Actual

Phase

Phase 1

Conditions

Healthy

Interventions

JP-1366 20mg tablet
JP-1366 20mg capsule

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 30, 2022Actual

Primary Completion Date

Oct 9, 2022Actual

Completion Date

Nov 9, 2022Actual

First Submitted Date

Apr 3, 2023

First Submission Date that Met QC Criteria

Apr 3, 2023

First Posted Date

Apr 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2023

Last Update Posted Date

Apr 20, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sequence A	Experimental	R → Washout period(7days) → T	Drug: JP-1366 20mg tablet Drug: JP-1366 20mg capsule
Sequence B	Experimental	T → Washout period(7days) → R	Drug: JP-1366 20mg tablet Drug: JP-1366 20mg capsule

Interventions

Name	Type	Description	Arm Group Labels	Other Names
JP-1366 20mg tablet	Drug	T : JP-1366 20mg tablet	Sequence A Sequence B

Outcomes Module

Primary Outcomes

Measure	Description	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D004304	Dosage Forms
D004364	Pharmaceutical Preparations