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A Pharmacokinetic Study of JKB-122 Tablets Compared to Capsule

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04313205
Recruitment Status : Not yet recruiting
First Posted : March 18, 2020
Last Update Posted : July 15, 2020
Sponsor:
Information provided by (Responsible Party):
TaiwanJ Pharmaceuticals Co., Ltd

Tracking Information
First Submitted Date  ICMJE March 16, 2020
First Posted Date  ICMJE March 18, 2020
Last Update Posted Date July 15, 2020
Estimated Study Start Date  ICMJE August 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2020)
Area under the curve from the time of dosing to steady state (AUC¬(0-τ)ss¬¬) [ Time Frame: 2 WEEKS ]
Plasma PK parameters will be measured comparison between JKB-122 capsule and JKB-122 tablet
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2020)
Number of Adverse events (AEs) observed [ Time Frame: 2 WEEKS ]
Safety observation of the drug treatment.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pharmacokinetic Study of JKB-122 Tablets Compared to Capsule
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Autoimmune Hepatitis
Intervention  ICMJE Drug: JKB-122 in capsule or tablet form
JKB-122 is a TLR4 antagonist and will be administrated in capsule or tablet form
Study Arms  ICMJE
  • Active Comparator: Capsule
    JKB-122 capsule on period 1 followed by JKB-122 Tablet on period 2
    Intervention: Drug: JKB-122 in capsule or tablet form
  • Active Comparator: Tablet
    JKB-122 tablet on period 1 followed by JKB-122 capsule on period 2
    Intervention: Drug: JKB-122 in capsule or tablet form
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 16, 2020)
8
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Ying-Chu Shih, PhD +886-36587721 info@taiwanj.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04313205
Other Study ID Numbers  ICMJE TWJ-SR122
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party TaiwanJ Pharmaceuticals Co., Ltd
Study Sponsor  ICMJE TaiwanJ Pharmaceuticals Co., Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account TaiwanJ Pharmaceuticals Co., Ltd
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP