A Pharmacokinetic Study of JKB-122 Tablets Compared to Capsule

Phase 1

• Conditions: Autoimmune Hepatitis
• Interventions: Drug: JKB-122 in capsule or tablet form

• Registration Number: NCT04313205
• Lead Sponsor: TaiwanJ Pharmaceuticals Co., Ltd

Brief Summary

The purpose of this study is to compare the pharmacokinetics of JKB-122 tablets with JKB-122 capsules in healthy male subjects subjects.

Detailed Description

This clinical study will be a randomized, open-label, multiple-dose, two-period, crossover study in healthy male subjects. After screening, subjects will be randomized to receive either JKB-122 tablet or JKB-122 capsule in a 1:1 ratio. There will be two dosing periods (Period 1 and Period 2). Subjects who receive JKB-122 capsule during Period 1 will receive JKB-122 tablet during Period 2 and vice versa. The 2 dosing periods will be separated by a washout period.

Study Timeline

• Study First Submitted: 2020-03-16
• Study First Submitted QC: 2020-03-16
• Study First Posted: 2020-03-18
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-13
• Last Update Posted: 2020-07-15
• Study Start: 2020-08
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 8

Inclusion Criteria

1. The subject has a body mass index (BMI) range of 18.5 and < 25.0 kg/m2 and weighs at least 50 kg.
2. Agreement for subject and female partner of childbearing potential to use acceptable method of contraception
3. The subject provided written informed consent.

Exclusion Criteria

1. Any history or evidence of any clinically significant major disease or malignancy, as judged by the Investigator.
2. Any clinically significant abnormality following the Investigator's review of the physical examination, ECG and clinical study protocol-defined clinical laboratory tests.
3. Use of prescribed or non-prescribed drugs (including vitamins, natural and herbal remedies, e.g. St. John's Wort) in the 2 weeks prior to study drug administration.
4. Consumption of grapefruit, pomelo, citrus fruits, starfruit, pomegranate, papaya, mango, rambutan, kiwi fruit, dragon fruit or passion fruit and products containing these fruits in the 2 weeks prior to study drug administration.
5. Current smoker or history of smoking within 3 months before the Screening Visit.
6. History of drinking more than 21 units of alcohol per week within 3 months prior to the Screening Visit.
7. Any use of drugs-of-abuse within 3 months before the Screening Visit.
8. Any significant blood loss or donation of blood (250 ml within 2 months or 500 ml within 3 months) prior to study drug administration.
9. Positive serology test for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCVAb) or human immunodeficiency virus.
10. Participation in any clinical study or administration of any investigational product within 1 month of study drug administration.
11. The subject has any other condition, which in the opinion of the Investigator precludes the subject's participation in the clinical study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tablet	JKB-122 in capsule or tablet form	JKB-122 tablet on period 1 followed by JKB-122 capsule on period 2
Capsule	JKB-122 in capsule or tablet form	JKB-122 capsule on period 1 followed by JKB-122 Tablet on period 2

Primary Outcome Measures

Name	Time	Method
Area under the curve from the time of dosing to steady state (AUC¬(0-τ)ss¬¬)	2 WEEKS	Plasma PK parameters will be measured comparison between JKB-122 capsule and JKB-122 tablet

Secondary Outcome Measures

Name	Time	Method
Number of Adverse events (AEs) observed	2 WEEKS	Safety observation of the drug treatment.