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Effects of Food on the Pharmacokinetics of DWJ1458 in Healthy Adults

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. Read our disclaimer for details.
 
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Recruitment Status : Withdrawn (We decided to discontinue this particular clinical study through internal discussion.)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.

Brief Summary:
The purpose of this study is to evaluate the food effect on the pharmacokinetics of DWJ1458 after oral administration in healthy volunteers.

Condition or disease Intervention/treatment Phase
Healthy Drug: DWJ1458 (fasted) Drug: DWJ1458 (fed) Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : May 28, 2020
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : November 30, 2020

Arm Intervention/treatment
Experimental: Group 1
Subjects take DWJ1458 on a fasted condition, and after wash-out period, take DWJ1458 with a high-fat diet.
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

Experimental: Group 2
Subjects take DWJ1458 with a high-fat diet, and after wash-out period, take DWJ1458 on a fasted condition.
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




Primary Outcome Measures :
  1. 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

  2. Pharmacokinetic parameter of DWJ1458: Cmax [ Time Frame: 0 - 144 hours after dosing ]
    Maximum plasma drug concentration


Secondary Outcome Measures :
  1. 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

  2. Pharmacokinetic parameter of DWJ1458: Tmax [ Time Frame: 0 - 144 hours after dosing ]
    Time to reach maximum plasma concentration following drug administration

  3. Pharmacokinetic parameter of DWJ1458: t1/2 [ Time Frame: 0 - 144 hours after dosing ]
    Elimination half-life

  4. Pharmacokinetic parameter of DWJ1458: Vd/F [ Time Frame: 0 - 144 hours after dosing ]
    Apparent volume of distribution after oral administration

  5. Pharmacokinetic parameter of DWJ1458: Cl/F [ Time Frame: 0 - 144 hours after dosing ]
    Apparent total clearance of drug from plasma after oral administration



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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04393597


Locations
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Korea, Republic of
Yonsei University Health System, Severance Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.
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Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT04393597    
Other Study ID Numbers: DW_DWJ1458102
First Posted: May 19, 2020    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No