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Effects of Food on the Pharmacokinetics of DWJ1458 in Healthy Adults

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ClinicalTrials.gov Identifier: NCT04393597
Recruitment Status : Withdrawn (We decided to discontinue this particular clinical study through internal discussion.)
First Posted : May 19, 2020
Last Update Posted : June 12, 2020
Sponsor:
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.

Tracking Information
First Submitted Date  ICMJE May 13, 2020
First Posted Date  ICMJE May 19, 2020
Last Update Posted Date June 12, 2020
Estimated Study Start Date  ICMJE May 28, 2020
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2020)
  • Pharmacokinetic parameter of DWJ1458: AUC0-t [ Time Frame: 0 - 144 hours after dosing ]
    Area under the plasma concentration-time curve from time 0 to time t
  • Pharmacokinetic parameter of DWJ1458: Cmax [ Time Frame: 0 - 144 hours after dosing ]
    Maximum plasma drug concentration
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2020)
  • Pharmacokinetic parameter of DWJ1458: AUCinf [ Time Frame: 0 - 144 hours after dosing ]
    Area under the plasma concentration-time curve from drug administration to drug elimination
  • Pharmacokinetic parameter of DWJ1458: Tmax [ Time Frame: 0 - 144 hours after dosing ]
    Time to reach maximum plasma concentration following drug administration
  • Pharmacokinetic parameter of DWJ1458: t1/2 [ Time Frame: 0 - 144 hours after dosing ]
    Elimination half-life
  • Pharmacokinetic parameter of DWJ1458: Vd/F [ Time Frame: 0 - 144 hours after dosing ]
    Apparent volume of distribution after oral administration
  • Pharmacokinetic parameter of DWJ1458: Cl/F [ Time Frame: 0 - 144 hours after dosing ]
    Apparent total clearance of drug from plasma after oral administration
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 Effects of Food on the Pharmacokinetics of DWJ1458 in Healthy Adults
Official Title  ICMJE A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Effects of Food on the Pharmacokinetics of Orally Administered DWJ1458 in Healthy Adults
Brief Summary The purpose of this study is to evaluate the food effect on the pharmacokinetics of DWJ1458 after oral administration in healthy volunteers.
Detailed Description The purpose of this study is to evaluate the food effect on the pharmacokinetics of DWJ1458 after oral administration in healthy volunteers: Randomized, open-label, oral, single-dose, crossover study
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 Healthy
Intervention  ICMJE
  • Drug: DWJ1458 (fasted)
    Subjects take single dose of DWJ1458 on a fated condition
  • Drug: DWJ1458 (fed)
    Subjects take single dose of DWJ1458 after high-fat diet
Study Arms  ICMJE
  • Experimental: Group 1
    Subjects take DWJ1458 on a fasted condition, and after wash-out period, take DWJ1458 with a high-fat diet.
    Interventions:
    • Drug: DWJ1458 (fasted)
    • Drug: DWJ1458 (fed)
  • Experimental: Group 2
    Subjects take DWJ1458 with a high-fat diet, and after wash-out period, take DWJ1458 on a fasted condition.
    Interventions:
    • Drug: DWJ1458 (fasted)
    • Drug: DWJ1458 (fed)
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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 10, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: May 17, 2020)
16
Estimated Study Completion Date  ICMJE November 30, 2020
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 19 to 55 years
  • BMI 18.5≥ and ≤27.0 kg/m²
  • Female subjects must be menopause or surgically infertility.
  • Male subjects must consent to contraception for at least 60 days after the study period and the final administration of the study drug.
  • Those who understand the requirements of the study and sign a written informed consent, and also accept all the restrictions imposed during the course of the study.

Exclusion Criteria:

  • History of hypersensitivity to investigational product
  • Participation in a clinical drug study or bioequivalence study 6 months prior to the present study
  • The subject who is judged to be unsuitable as a test subject in a screening test.
  • The subject who is judged to be unsuitable for participation in a clinical trial due to other reasons determined by the investigators.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04393597
Other Study ID Numbers  ICMJE DW_DWJ1458102
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Daewoong Pharmaceutical Co. LTD.
Study Sponsor  ICMJE Daewoong Pharmaceutical Co. LTD.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Daewoong Pharmaceutical Co. LTD.
Verification Date June 2020

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