Clinical Trials Logo
  1. Home
  2. Healthy
  3. NCT05814809
  4. Details
NCT05814809 Clinical Trial

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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05814809
Other study ID # JP-1366-104
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 30, 2022
Est. completion date November 9, 2022

Study information
Verified date April 2023
Source Onconic Therapeutics Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date November 9, 2022
Est. primary completion date October 9, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• JP-1366 20mg tablet
T : JP-1366 20mg tablet
• JP-1366 20mg capsule
R : JP-1366 20mg capsule

Locations
Country Name City State
Korea, Republic of Yangji Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Onconic Therapeutics Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary AUCt of Zastaprazan(JP-1366 20mg) Pre-dose(0 hour) and up to 34 hours in each period
Primary Cmax of Zastaprazan(JP-1366 20mg) Pre-dose(0 hour) and up to 34 hours in each period
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1