NCT03364985

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Dec 2017

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

December 3, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 7, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
Last Updated

August 21, 2019

Status Verified

August 1, 2019

Enrollment Period

1.5 years

First QC Date

November 29, 2017

Last Update Submit

August 19, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

  • Number and percentage of Participants With Adverse Events (AE)

    All AE standardized using MedDRA was assessed by investigator using the protocol defined grading system. Intensity was categorized as mild, moderate and severe

    Day -2(Randomization) to Day 8~12(Post-study visit) in single ascending dose or Day-3d to Day 22~ (Post-study visit)

  • Number and percentage of Participants With Adverse Drug Reactions (ADR)

    An adverse drug reaction (ADR) is an injury caused by taking an investigational product

    Day -2(Randomization) to Day 8~12(Post-study visit) in single ascending dose or Day-3d to Day 22~ (Post-study visit)

  • Number of Participants With Clinically Significant Vital Sign findings

    Blood pressure, pulse and body temperature were tested. The Average, Median, Standard Deviation, Min, Max values will be calculated to assess the safety/tolerability

    Day -2(Randomization) to Day 8~12(Post-study visit) in single ascending dose or Day-3d to Day 22~ (Post-study visit)

  • Number of Participants With Clinically Significant Electrocardiogram(12-lead ECG) findings

    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).

    Day -2(Randomization) to Day 8~12(Post-study visit) in single ascending dose or Day-3d to Day 22~ (Post-study visit)

  • Number of Participants With Clinically Significant Laboratory results

    Hematology, Blood chemistry, Coagulation and Urinalysis were tested. The Average, Median, Standard Deviation, Min, Max values will be calculated to assess the safety/tolerability.

    Day -2(Randomization) to Day 8~12(Post-study visit) in single ascending dose or Day-3d to Day 22~ (Post-study visit)

Secondary Outcomes (17)

  • Cmax: Maximum concentration of DWP16001

    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

  • Cmax,ss: Maximum concentration of DWP16001 at steady state

    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

  • Cmin,ss: Minimum concentration of DWP16001 at steady state

    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

  • Time of maximum concentration

    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

  • Tmax,ss: Time of maximum concentration at steady state

    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

  • +12 more secondary outcomes

Study Arms (10)

Cohort 1: DWP16001 Amg

EXPERIMENTAL

DWP16001 Amg, tablets, orally, single dose administration

Drug: DWP16001Drug: PlaceboDrug: Dapagliflozin

Cohort 2: DWP16001 Bmg

EXPERIMENTAL

DWP16001 Bmg, tablets, orally, single dose administration

Drug: DWP16001Drug: PlaceboDrug: Dapagliflozin

Cohort 3: DWP16001 Cmg

EXPERIMENTAL

DWP16001 Cmg, tablets, orally, single dose administration

Drug: DWP16001Drug: PlaceboDrug: Dapagliflozin

Cohort 4: DWP16001 Dmg

EXPERIMENTAL

DWP16001 Dmg, tablets, orally, single dose administration

Drug: DWP16001Drug: PlaceboDrug: Dapagliflozin

Cohort 5: DWP16001 Emg

EXPERIMENTAL

DWP16001 Emg, tablets, orally, single dose administration

Drug: DWP16001Drug: PlaceboDrug: Dapagliflozin

Cohort 6: DWP16001 Fmg

EXPERIMENTAL

DWP16001 placebo-matching tablets, Active-control placebo-matching tablets, orally, repeated dose administration(for 15days)

Drug: DWP16001Drug: PlaceboDrug: Dapagliflozin

Cohort 7: DWP16001 Gmg

EXPERIMENTAL

DWP16001 placebo-matching tablets, Active-control placebo-matching tablets, orally, repeated dose administration(for 15days)

Drug: DWP16001Drug: PlaceboDrug: Dapagliflozin

Cohort 8: DWP16001 Hmg

EXPERIMENTAL

DWP16001 placebo-matching tablets, Active-control placebo-matching tablets, orally, repeated dose administration(for 15days)

Drug: DWP16001Drug: PlaceboDrug: Dapagliflozin

Cohort 9: DWP16001 Img

EXPERIMENTAL

DWP16001 placebo-matching tablets, Active-control placebo-matching tablets, orally, repeated dose administration(for 15days)

Drug: DWP16001Drug: PlaceboDrug: Dapagliflozin

Cohort 10: DWP16001 Jmg

EXPERIMENTAL

DWP16001 placebo-matching tablets, Active-control placebo-matching tablets, orally, repeated dose administration(for 15days)

Drug: DWP16001Drug: PlaceboDrug: Dapagliflozin

Interventions

DWP16001DRUG

DWP16001 tablets

Cohort 10: DWP16001 JmgCohort 1: DWP16001 AmgCohort 2: DWP16001 BmgCohort 3: DWP16001 CmgCohort 4: DWP16001 DmgCohort 5: DWP16001 EmgCohort 6: DWP16001 FmgCohort 7: DWP16001 GmgCohort 8: DWP16001 HmgCohort 9: DWP16001 Img
PlaceboDRUG

DWP16001 placebo-matching tablets, Active control placebo-matching tablets

Cohort 10: DWP16001 JmgCohort 1: DWP16001 AmgCohort 2: DWP16001 BmgCohort 3: DWP16001 CmgCohort 4: DWP16001 DmgCohort 5: DWP16001 EmgCohort 6: DWP16001 FmgCohort 7: DWP16001 GmgCohort 8: DWP16001 HmgCohort 9: DWP16001 Img
DapagliflozinDRUG

Forxiga®

Cohort 10: DWP16001 JmgCohort 1: DWP16001 AmgCohort 2: DWP16001 BmgCohort 3: DWP16001 CmgCohort 4: DWP16001 DmgCohort 5: DWP16001 EmgCohort 6: DWP16001 FmgCohort 7: DWP16001 GmgCohort 8: DWP16001 HmgCohort 9: DWP16001 Img

Eligibility Criteria

Age19 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Presence of a clinically significant hepatic, renal, nervous, respiratory, endocrine, blood•tumor, cardiovascular, urogenital, psychiatric disorder or prior history.
  • 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.
  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Enavogliflozindapagliflozin

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2017

First Posted

December 7, 2017

Study Start

December 3, 2017

Primary Completion

May 21, 2019

Study Completion

July 30, 2019

Last Updated

August 21, 2019

Record last verified: 2019-08

Locations

KR(1)