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A Pharmacokinetic Study of JKB-122 Tablets Compared to Capsule

Primary Purpose

Autoimmune Hepatitis

Status

Unknown status

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

JKB-122 in capsule or tablet form

About this trial

This is an interventional treatment trial for Autoimmune Hepatitis

Eligibility Criteria

20 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Any history or evidence of any clinically significant major disease or malignancy, as judged by the Investigator.
Any clinically significant abnormality following the Investigator's review of the physical examination, ECG and clinical study protocol-defined clinical laboratory tests.
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.
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.
Current smoker or history of smoking within 3 months before the Screening Visit.
History of drinking more than 21 units of alcohol per week within 3 months prior to the Screening Visit.
Any use of drugs-of-abuse within 3 months before the Screening Visit.
Any significant blood loss or donation of blood (250 ml within 2 months or 500 ml within 3 months) prior to study drug administration.
Positive serology test for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCVAb) or human immunodeficiency virus.
Participation in any clinical study or administration of any investigational product within 1 month of study drug administration.
The subject has any other condition, which in the opinion of the Investigator precludes the subject's participation in the clinical study.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Capsule

Tablet

Arm Description

JKB-122 capsule on period 1 followed by JKB-122 Tablet on period 2

JKB-122 tablet on period 1 followed by JKB-122 capsule on period 2

Outcomes

Primary Outcome Measures

Area under the curve from the time of dosing to steady state (AUC¬(0-τ)ss¬¬)

Plasma PK parameters will be measured comparison between JKB-122 capsule and JKB-122 tablet

Secondary Outcome Measures

Number of Adverse events (AEs) observed

Safety observation of the drug treatment.

Full Information

NCT ID

NCT04313205

First Posted

March 16, 2020

Last Updated

July 13, 2020

Sponsor

TaiwanJ Pharmaceuticals Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT04313205

Brief Title

A Pharmacokinetic Study of JKB-122 Tablets Compared to Capsule

Official Title

A Randomized, Open-label, Multiple-dose, Two-period, Crossover, Study to Investigate the Pharmacokinetic Profile of 2 Formulations of JKB-122 in Healthy Male Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Unknown status

Study Start Date

August 2020 (Anticipated)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

TaiwanJ Pharmaceuticals Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autoimmune Hepatitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Capsule

Arm Type

Active Comparator

Arm Description

JKB-122 capsule on period 1 followed by JKB-122 Tablet on period 2

Arm Title

Tablet

Arm Type

Active Comparator

Arm Description

JKB-122 tablet on period 1 followed by JKB-122 capsule on period 2

Intervention Type

Drug

Intervention Name(s)

JKB-122 in capsule or tablet form

Intervention Description

JKB-122 is a TLR4 antagonist and will be administrated in capsule or tablet form

Primary Outcome Measure Information:

Title

Area under the curve from the time of dosing to steady state (AUC¬(0-τ)ss¬¬)

Description

Plasma PK parameters will be measured comparison between JKB-122 capsule and JKB-122 tablet

Time Frame

2 WEEKS

Secondary Outcome Measure Information:

Title

Number of Adverse events (AEs) observed

Description

Safety observation of the drug treatment.

Time Frame

2 WEEKS

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The subject has a body mass index (BMI) range of 18.5 and < 25.0 kg/m2 and weighs at least 50 kg. Agreement for subject and female partner of childbearing potential to use acceptable method of contraception The subject provided written informed consent. Exclusion Criteria: Any history or evidence of any clinically significant major disease or malignancy, as judged by the Investigator. Any clinically significant abnormality following the Investigator's review of the physical examination, ECG and clinical study protocol-defined clinical laboratory tests. 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. 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. Current smoker or history of smoking within 3 months before the Screening Visit. History of drinking more than 21 units of alcohol per week within 3 months prior to the Screening Visit. Any use of drugs-of-abuse within 3 months before the Screening Visit. Any significant blood loss or donation of blood (250 ml within 2 months or 500 ml within 3 months) prior to study drug administration. Positive serology test for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCVAb) or human immunodeficiency virus. Participation in any clinical study or administration of any investigational product within 1 month of study drug administration. The subject has any other condition, which in the opinion of the Investigator precludes the subject's participation in the clinical study.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ying-Chu Shih, PhD

Phone

+886-36587721

info@taiwanj.com

12. IPD Sharing Statement

Plan to Share IPD

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A Pharmacokinetic Study of JKB-122 Tablets Compared to Capsule

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