NCT03769870

Brief Summary

A randomized, open-label, cross-over, multiple dosing study to evaluate drug-drug interaction between Teneligliptin and Atorvastatin in healthy male adults

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2019

Shorter than P25 for phase_1

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

December 6, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 10, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

January 11, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2019

Completed
Last Updated

May 30, 2019

Status Verified

May 1, 2019

Enrollment Period

2 months

First QC Date

December 6, 2018

Last Update Submit

May 28, 2019

Conditions

Diabete Mellitus

Outcome Measures

Primary Outcomes (2)

  • Cmax,ss(Maximum concentration at steady state)

    24 hours

  • AUCτ,ss(Area under the concentration-time curve at steady state)

    24hours

Study Arms (3)

Teneligliptin

OTHER
Drug: Teneligliptin 20mg/day

Atorvastatin

OTHER
Drug: Atorvastatin 40mg/Day

Teneligliptin + Atorvastatin

OTHER
Drug: Teneligliptin 20mg/day + Atorvastatin 40mg/day

Interventions

Teneligliptin 20mg/dayDRUG

cross-over

Teneligliptin
Atorvastatin 40mg/DayDRUG

cross-over

Atorvastatin
Teneligliptin 20mg/day + Atorvastatin 40mg/dayDRUG

cross-over

Teneligliptin + Atorvastatin

Eligibility Criteria

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

You may qualify if:

  • Healthy male adult 19 to 45 years
  • Body weight ≥ 50kg, and BMI between 18-29kg/m2 at screening
  • Subject who agrees to use a medically acceptable double-barrier method of contraception and not to donate sperms from the first dose until 2 months after the last dose.
  • Subject who was given, and fully understood, the information about the study, and has provided voluntary written informed consent to participate in the study and agreed to comply with the study requirements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea Universitiy Guro Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidineAtorvastatin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Design

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

Study Record Dates

First Submitted

December 6, 2018

First Posted

December 10, 2018

Study Start

January 11, 2019

Primary Completion

February 25, 2019

Study Completion

February 25, 2019

Last Updated

May 30, 2019

Record last verified: 2019-05

Locations

KR(1)