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

Onconic Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: JP-1366 20mg tablet; Drug: JP-1366 20mg capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT05814809

JP-1366-104

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Sequence A

Experimental group

Description:

R → Washout period(7days) → T

Treatment:

Drug: JP-1366 20mg capsule

Drug: JP-1366 20mg tablet

Sequence B

Experimental group

Description:

T → Washout period(7days) → R

Treatment:

Drug: JP-1366 20mg capsule

Drug: JP-1366 20mg tablet