NCT04473417

Brief Summary

This is the phase I study to evaluate the pharmacokinetics and safety of DA-2811 and Forxiga® after a single oral dose in healthy volunteers. The study will also compare the pharmacokinetics and safety profiles of DA-2811 under fasting and fed states in healthy subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Aug 2020

Shorter than P25 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

July 13, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 16, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

August 4, 2020

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2020

Completed
Last Updated

March 5, 2021

Status Verified

March 1, 2021

Enrollment Period

22 days

First QC Date

July 13, 2020

Last Update Submit

March 3, 2021

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • AUClast

    Area under the plasma concentration-time curve from time zero to time the last quantifiable time

    pre-dose~48 hours post-dose

  • Cmax

    Maximum plasma concentration

    pre-dose~48 hours post-dose

Secondary Outcomes (3)

  • AUC(0 - ∞)

    pre-dose~48 hours post-dose

  • Tmax

    pre-dose~48 hours post-dose

  • t1/2

    pre-dose~48 hours post dose

Study Arms (4)

Part A, Sequence I

EXPERIMENTAL

Period I: Forxiga® → DA-2811, Period II: DA-2811 → Forxiga®

Drug: ForxigaDrug: DA-2811

Part A, Sequence II

EXPERIMENTAL

Period I: DA-2811 → Forxiga®, Period II: Forxiga® → DA-2811

Drug: ForxigaDrug: DA-2811

Part B, Sequence I

EXPERIMENTAL

Period I: DA-2811 under fasting state → DA-2811 under fed state, Period II:DA-2811 under fed state → DA-2811 under fasting state

Drug: DA-2811

Part B, Sequence II

EXPERIMENTAL

Period I: DA-2811 under fed state → DA-2811 under fasting state, Period II: DA-2811 under fasting state → DA-2811 under fed state

Drug: DA-2811

Interventions

ForxigaDRUG

single dose administration after 10hr fasting

Part A, Sequence IPart A, Sequence II
DA-2811DRUG

single dose administration after 10hr fasting

Part A, Sequence IPart A, Sequence II

Eligibility Criteria

Age19 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and/or female subjects
  • BMI between 18.5 and 29.9 kg/m2 and weigh at least 50 kg
  • Volunteer who totally understands the progress of this clinical trial, make decision by his or her free will, and signed a consent form to follow the progress.

You may not qualify if:

  • Volunteer who has present or past history of clinically significant cardiovascular, respiratory, urinary, gastrointestinal, hepatic, renal, skin, immunological, musculoskeletal, endocrinal, neurological, psychiatric and/or hematological disease
  • Vulnerable to dehydration due to poor oral intake or clinically significant dehydration as judged by the investigator
  • History of gastrointestinal disease or any gastrointestinal surgery(except for simple appendectomy, hernia surgery, hemorrhoid surgery)
  • History of diseases that may impact absorption, distribution, metabolism, and excretion of the study drugs.
  • Hypersensitivity to a drug containing an ingredient of the investigational product, Sodium glucose transporter-2 inhibitors, additional ingredient or other drugs (e.g., aspirin, antibiotics, etc.) or medical history of clinically significant hypersensitivity.
  • History of clinically significant active chronic disease
  • volunteer who has genetic disorder like lapp lactase deficiency or glucose-galactose malabsorption.
  • History of clinically significant allergies including drug allergies
  • History of drug abuse or addicted
  • Clinical laboratory test values are outside the accepted normal range
  • Participation in another clinical trial within 6 months of the first IP administration
  • Sexually active women of childbearing potential not consistently and correctly practicing birth control by dual contraceptive method until 2 months after last IP administration
  • Breast-feeding period, pregnant, or positive to urine pregnancy test (conducted before the first drug administration)
  • Subjects considered as unsuitable based on medical judgement by investigators

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bundangseoul national unversity hospital

Sŏngnam, GyeonggiDo, South Korea

Location

MeSH Terms

Interventions

dapagliflozin

Study Officials

  • JaeYong Chung

    Bundang Seoul National University Hospital Clinical Trial Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2020

First Posted

July 16, 2020

Study Start

August 4, 2020

Primary Completion

August 26, 2020

Study Completion

October 12, 2020

Last Updated

March 5, 2021

Record last verified: 2021-03

Locations

KR(1)