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

Sponsor
Onconic Therapeutics Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT05814809
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
1.3
Actual Duration (Months)
22.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: JP-1366 20mg tablet
  • Drug: JP-1366 20mg capsule
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I Study to Evaluate the Safety and Pharmacokinetics of JP-1366 in Healthy Adult Volunteers
Actual Study Start Date :
Sep 30, 2022
Actual Primary Completion Date :
Oct 9, 2022
Actual Study Completion Date :
Nov 9, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. AUCt of Zastaprazan(JP-1366 20mg) [Pre-dose(0 hour) and up to 34 hours in each period]

    2. Cmax of Zastaprazan(JP-1366 20mg) [Pre-dose(0 hour) and up to 34 hours in each period]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yangji Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Onconic Therapeutics Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Onconic Therapeutics Inc.
    ClinicalTrials.gov Identifier:
    NCT05814809
    Other Study ID Numbers:
    • JP-1366-104
    First Posted:
    Apr 18, 2023
    Last Update Posted:
    Apr 20, 2023
    Last Verified:
    Apr 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Apr 20, 2023