NCT02167061

Brief Summary

This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229\_01 and to investigate the effect of food on the pharmacokinetics of DA-1229\_01 in healthy male volunteers

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P75+ for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Jul 2014

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

June 11, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 18, 2014

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

December 2, 2014

Status Verified

November 1, 2014

Enrollment Period

4 months

First QC Date

June 11, 2014

Last Update Submit

November 27, 2014

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • Area Under Curve(AUC)last of Evogliptin and Metformin

    1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose

  • Maximum of concentration (Cmax) of Evogliptin and Metformin

    1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose

Secondary Outcomes (5)

  • Time of maximum concentration(Tmax) of Evogliptin and Metformin

    1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose

  • Terminal half-life(t1/2) of Evogliptin and Metformin

    1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose

  • Apparent Clearance(CL/F) of Evogliptin and Metformin

    1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose

  • Area Under Curve(AUC)inf of Evogliptin and Metformin

    1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose

  • Time prior to the first measurable concentration (tlag) of Metformin (only in Part 2 trial)

    1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose

Study Arms (4)

(Part 1) DA-1229_01 → E+M

EXPERIMENTAL

DA-1229\_01 : Evogliptin/Metformin XR 5/1000mg E : Evogliptin 5 mg M : Metformin XR 1000 mg

Drug: DA-1229_01Drug: E+M

(Part 1) E+M → DA-1229_01

EXPERIMENTAL

DA-1229\_01 : Evogliptin/Metformin XR 5/1000mg E : Evogliptin 5 mg M : Metformin XR 1000 mg

Drug: DA-1229_01Drug: E+M

(Part 2) DA-1229_01 fast → fed

EXPERIMENTAL

DA-1229\_01 : Evogliptin/Metformin XR 5/1000mg Fast : administration on an empty stomach Fed: administration after high-fat diet

Drug: DA-1229_01 fastDrug: DA-1229_01 fed

DA-1229_01 fed → fast

EXPERIMENTAL

DA-1229\_01 : Evogliptin/Metformin XR 5/1000mg Fast : administration on an empty stomach Fed: administration after high-fat diet

Drug: DA-1229_01 fastDrug: DA-1229_01 fed

Interventions

DA-1229_01DRUG

complex single administration

Also known as: Evogliptin/Metformin XR 5/1000 mg
(Part 1) DA-1229_01 → E+M(Part 1) E+M → DA-1229_01
E+MDRUG

co-administration of 2 drugs

Also known as: Evogliptin 5 mg + Metformin XR 1000 mg
(Part 1) DA-1229_01 → E+M(Part 1) E+M → DA-1229_01
DA-1229_01 fastDRUG
(Part 2) DA-1229_01 fast → fedDA-1229_01 fed → fast
DA-1229_01 fedDRUG
(Part 2) DA-1229_01 fast → fedDA-1229_01 fed → fast

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 20 to 45, healthy male subjects(at screening)
  • Body weight between 55kg - 90kg, BMI between 18.0 - 27.0
  • FPG 60-125mg/dL glucose level(at screening)
  • Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.

You may not qualify if:

  • Volunteer who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder)
  • Volunteer who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded)
  • Volunteer who had drug(Aspirin, antibiotics) hypersensitivity reaction
  • Subject who already participated in other trials in 2 months
  • Subject who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trial Center, Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-one

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Kyung-sang Yu, Ph.d., M.B.A

    Seoul National University Hospital

    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

June 11, 2014

First Posted

June 18, 2014

Study Start

July 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

December 2, 2014

Record last verified: 2014-11

Locations

KR(1)