A Pharmacokinetic Study of JKB-122 Tablets Compared to Ca... | NCT04313205

Studies
A Pharmacokinetic Study of JKB-122 Tablets Compared to Capsule

NCT04313205

Sponsor

TaiwanJ Pharmaceuticals Co., Ltd

Status

Unknown status

Last Update Posted

Jul 15, 2020Actual

Enrollment

8Estimated

Phase

Phase 1

Conditions

Autoimmune Hepatitis

Interventions

JKB-122 in capsule or tablet form

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2020Estimated

Primary Completion Date

Dec 2020Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Mar 16, 2020

First Submission Date that Met QC Criteria

Mar 16, 2020

First Posted Date

Mar 18, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2020

Last Update Posted Date

Jul 15, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Capsule	Active Comparator	JKB-122 capsule on period 1 followed by JKB-122 Tablet on period 2	Drug: JKB-122 in capsule or tablet form
Tablet	Active Comparator	JKB-122 tablet on period 1 followed by JKB-122 capsule on period 2	Drug: JKB-122 in capsule or tablet form

Interventions

Name	Type	Description	Arm Group Labels	Other Names
JKB-122 in capsule or tablet form	Drug	JKB-122 is a TLR4 antagonist and will be administrated in capsule or tablet form	Capsule Tablet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	2 WEEKS

Secondary Outcomes

Measure	Description	Time Frame
Number of Adverse events (AEs) observed	Safety observation of the drug treatment.	2 WEEKS

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D006521	Hepatitis, Chronic
D006505	Hepatitis
D008107	Liver Diseases
D004066	Digestive System Diseases

ID	Term
C000627037	JKB-122
D002214	Capsules

ID	Term
D004304	Dosage Forms
D004364	Pharmaceutical Preparations