Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP16001 After Oral Administration in Healthy Male Volunteers

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: NCT03364985
Recruitment Status : Completed
First Posted : December 7, 2017
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This is a dose block-randomized, double-blind, placebo- and active-controlled, single and multiple dosing, dose-escalation clinical phase 1 trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of DWP16001 after oral administration in healthy male volunteers.

Condition or disease Intervention/treatment Phase
Healthy Drug: DWP16001 Drug: Placebo Drug: Dapagliflozin Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase I, Randomized, Double-blind, Placebo- and Active-controlled, Single- and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of DWP16001 Following Oral Administration in Healthy Male Volunteers
Actual Study Start Date : December 3, 2017
Actual Primary Completion Date : May 21, 2019
Actual Study Completion Date : July 30, 2019
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Cohort 1: DWP16001 Amg
DWP16001 Amg, tablets, orally, single dose administration
 Drug: DWP16001
DWP16001 tablets

Drug: Placebo
DWP16001 placebo-matching tablets, Active control placebo-matching tablets

Drug: Dapagliflozin
Forxiga®
Experimental: Cohort 2: DWP16001 Bmg
DWP16001 Bmg, tablets, orally, single dose administration
 Drug: DWP16001
DWP16001 tablets

Drug: Placebo
DWP16001 placebo-matching tablets, Active control placebo-matching tablets

Drug: Dapagliflozin
Forxiga®
Experimental: Cohort 3: DWP16001 Cmg
DWP16001 Cmg, tablets, orally, single dose administration
 Drug: DWP16001
DWP16001 tablets

Drug: Placebo
DWP16001 placebo-matching tablets, Active control placebo-matching tablets

Drug: Dapagliflozin
Forxiga®
Experimental: Cohort 4: DWP16001 Dmg
DWP16001 Dmg, tablets, orally, single dose administration
 Drug: DWP16001
DWP16001 tablets

Drug: Placebo
DWP16001 placebo-matching tablets, Active control placebo-matching tablets

Drug: Dapagliflozin
Forxiga®
Experimental: Cohort 5: DWP16001 Emg
DWP16001 Emg, tablets, orally, single dose administration
 Drug: DWP16001
DWP16001 tablets

Drug: Placebo
DWP16001 placebo-matching tablets, Active control placebo-matching tablets

Drug: Dapagliflozin
Forxiga®
Experimental: Cohort 6: DWP16001 Fmg
DWP16001 placebo-matching tablets, Active-control placebo-matching tablets, orally, repeated dose administration(for 15days)
 Drug: DWP16001
DWP16001 tablets

Drug: Placebo
DWP16001 placebo-matching tablets, Active control placebo-matching tablets

Drug: Dapagliflozin
Forxiga®
Experimental: Cohort 7: DWP16001 Gmg
DWP16001 placebo-matching tablets, Active-control placebo-matching tablets, orally, repeated dose administration(for 15days)
 Drug: DWP16001
DWP16001 tablets

Drug: Placebo
DWP16001 placebo-matching tablets, Active control placebo-matching tablets

Drug: Dapagliflozin
Forxiga®
Experimental: Cohort 8: DWP16001 Hmg
DWP16001 placebo-matching tablets, Active-control placebo-matching tablets, orally, repeated dose administration(for 15days)
 Drug: DWP16001
DWP16001 tablets

Drug: Placebo
DWP16001 placebo-matching tablets, Active control placebo-matching tablets

Drug: Dapagliflozin
Forxiga®
Experimental: Cohort 9: DWP16001 Img
DWP16001 placebo-matching tablets, Active-control placebo-matching tablets, orally, repeated dose administration(for 15days)
 Drug: DWP16001
DWP16001 tablets

Drug: Placebo
DWP16001 placebo-matching tablets, Active control placebo-matching tablets

Drug: Dapagliflozin
Forxiga®
Experimental: Cohort 10: DWP16001 Jmg
DWP16001 placebo-matching tablets, Active-control placebo-matching tablets, orally, repeated dose administration(for 15days)
 Drug: DWP16001
DWP16001 tablets

Drug: Placebo
DWP16001 placebo-matching tablets, Active control placebo-matching tablets

Drug: Dapagliflozin
Forxiga®


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number and percentage of Participants With Adverse Events (AE) [ Time Frame: Day -2(Randomization) to Day 8~12(Post-study visit) in single ascending dose or Day-3d to Day 22~ (Post-study visit) ]
    All AE standardized using MedDRA was assessed by investigator using the protocol defined grading system. Intensity was categorized as mild, moderate and severe

  2. Number and percentage of Participants With Adverse Drug Reactions (ADR) [ Time Frame: Day -2(Randomization) to Day 8~12(Post-study visit) in single ascending dose or Day-3d to Day 22~ (Post-study visit) ]
    An adverse drug reaction (ADR) is an injury caused by taking an investigational product

  3. Number of Participants With Clinically Significant Vital Sign findings [ Time Frame: Day -2(Randomization) to Day 8~12(Post-study visit) in single ascending dose or Day-3d to Day 22~ (Post-study visit) ]
    Blood pressure, pulse and body temperature were tested. The Average, Median, Standard Deviation, Min, Max values will be calculated to assess the safety/tolerability

  4. Number of Participants With Clinically Significant Electrocardiogram(12-lead ECG) findings [ Time Frame: Day -2(Randomization) to Day 8~12(Post-study visit) in single ascending dose or Day-3d to Day 22~ (Post-study visit) ]
    Ventricular rate, RR interval, PR interval, QRS duration, QTcB and QTcF were recorded. The results of 12-lead ECG will be categorized Normal/Abnormal NCS(No clinically significant)/Abnormal CS(clinically significant).

  5. Number of Participants With Clinically Significant Laboratory results [ Time Frame: Day -2(Randomization) to Day 8~12(Post-study visit) in single ascending dose or Day-3d to Day 22~ (Post-study visit) ]
    Hematology, Blood chemistry, Coagulation and Urinalysis were tested. The Average, Median, Standard Deviation, Min, Max values will be calculated to assess the safety/tolerability.


Secondary Outcome Measures :
  1. Cmax: Maximum concentration of DWP16001 [ Time Frame: 0 hour (pre-dose), 0.25 hour, 0.5 hour, 0.75 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, 12hour, 24 hour, 36 hour, 48 hour, 72 hour ]
    in single ascending dose cohort

  2. Cmax,ss: Maximum concentration of DWP16001 at steady state [ Time Frame: Day1 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour, Day 4, 7, 10, 13 0 hour (pre dose), Day 15 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour ]
    in multiple ascending dose cohort

  3. Cmin,ss: Minimum concentration of DWP16001 at steady state [ Time Frame: Day1 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour, Day 4, 7, 10, 13 0 hour (pre dose), Day 15 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour ]
    in multiple ascending dose cohort

  4. Time of maximum concentration [ Time Frame: 0 hour (pre-dose), 0.25 hour, 0.5 hour, 0.75 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, 12hour, 24 hour, 36 hour, 48 hour, 72 hour ]
    in single ascending dose cohort

  5. Tmax,ss: Time of maximum concentration at steady state [ Time Frame: Day1 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour, Day 4, 7, 10, 13 0 hour (pre dose), Day 15 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour ]
    in multiple ascending dose cohort

  6. AUClast: Area under the plasma concentration-time curve from time 0 to 72hours [ Time Frame: 0 hour (pre-dose), 0.25 hour, 0.5 hour, 0.75 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, 12hour, 24 hour, 36 hour, 48 hour, 72 hour ]
    in single ascending dose cohort

  7. AUCinf: Area under the plasma concentration-time curve from time 0 to infinity [ Time Frame: 0 hour (pre-dose), 0.25 hour, 0.5 hour, 0.75 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, 12hour, 24 hour, 36 hour, 48 hour, 72 hour ]
    in single ascending dose cohort

  8. AUCtau: Area under the plasma concentration-time curve from time 0 to tau(dosing interval) [ Time Frame: Day1 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour, Day 4, 7, 10, 13 0 hour (pre dose), Day 15 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour ]
    in multiple ascending dose cohort

  9. T1/2: Elimination half-life [ Time Frame: 0 hour (pre-dose), 0.25 hour, 0.5 hour, 0.75 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, 12hour, 24 hour, 36 hour, 48 hour, 72 hour ]
    in single ascending dose cohort

  10. T1/2: Elimination half-life [ Time Frame: Day1 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour, Day 4, 7, 10, 13 0 hour (pre dose), Day 15 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour ]
    in multiple ascending dose cohort

  11. concentration of serum glucose [ Time Frame: 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour ]
    in single ascending dose cohort

  12. concentration of serum glucose [ Time Frame: Day 1 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour, Day 4, 7, 10, 13 pre dose, Day 15 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour ]
    in multiple ascending dose cohort

  13. concentration of insulin [ Time Frame: Day -1 pre dose, 0.5, 1, 1.5, 2, 3, 4 hour, Day 15 pre dose, 0.5, 1, 1.5, 2, 3, 4 hour ]
    in multiple ascending dose cohort

  14. Changes from baseline for Body weight in kilograms [ Time Frame: Day -1 0 hour, Day 15 0 hour ]
    in multiple ascending dose cohort

  15. Changes from baseline for HbA1C in percent [ Time Frame: Day -1 0 hour, Day 15 0 hour ]
    in multiple ascending dose cohort

  16. concentration of Urine glucose excretion [ Time Frame: 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour ]
    in single ascending dose cohort

  17. concentration of Urine glucose excretion [ Time Frame: Day 1 pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour, Day 4, 7, 10, 13 pre dose, Day 15 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hour ]
    in multiple ascending dose cohort


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male adults aged 19 to 50 at the time of screening test.
  2. Body weight between 50.0 kg and 90.0 kg and Body Mass Index (BMI) between 18.0 and 27.0.
  3. Written consent on voluntary decision of participation prior to the screening procedure after being fully informed of and completely understanding this study.
  4. Eligible to participate in the study by discretion of the investigator following medical examination by interview, physical examination, and clinical examination.

Exclusion Criteria:

  1. Presence of a clinically significant hepatic, renal, nervous, respiratory, endocrine, blood•tumor, cardiovascular, urogenital, psychiatric disorder or prior history.
  2. Presence or prior history of a gastrointestinal disorder (e.g., gastrointestinal ulcers, gastritis, stomach cramps, gastroesophageal reflux disease, Crohn's disease, etc.), or prior history of surgery (except for simple appendectomy or hernia surgery) that may affect safety and PK/PD assessment.
  3. Hypersensitivity to a drug containing an ingredient of the investigational product (DWP16001), Dapagliflozin or similar ingredient or other drugs (e.g., aspirin, antibiotics, etc.) or medical history of clinically significant hypersensitivity.

  4. Following laboratory abnormalities identified during the screening test:

    • AST (SGOT), ALT (SGPT) >1.5 upper limit of normal range
    • Creatinine clearance calculated by the MDRD equation < 90 mL/min
    • Repeatedly confirmed QTc interval > 450 ms
    • Fasting serum glucose > 110mg/dL or < 70mg/dL
    • Serum HbA1c > 6.5 mg/dL
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03364985


Locations
Layout table for location information
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT03364985    
Other Study ID Numbers: DW_DWP16001001
First Posted: December 7, 2017    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Dapagliflozin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs