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Completed

NCT Number: NCT05814809

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

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

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Key information

Conditions

Healthy

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Yangji Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JP-1366 20mg tablet

Drug

T : JP-1366 20mg tablet

Other names: Zastaprazan 20mg

JP-1366 20mg capsule

Drug

R : JP-1366 20mg capsule

Other names: Zastaprazan 20mg

Primary outcomes

  1. AUCt of Zastaprazan(JP-1366 20mg)

    Time frame: Pre-dose(0 hour) and up to 34 hours in each period

  2. Cmax of Zastaprazan(JP-1366 20mg)

    Time frame: Pre-dose(0 hour) and up to 34 hours in each period

Sponsors and collaborators

Lead sponsor

Onconic Therapeutics Inc.

Industry

Registry information

Official study title

Phase I Study to Evaluate the Safety and Pharmacokinetics of JP-1366 in Healthy Adult Volunteers

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 18, 2023
Registry last updated
Apr 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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