NCT04874142

Brief Summary

To evaluate the safety and pharmacokinetics drug-drug interaction of YYC506-T and YYC506-A

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 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

Study Start

First participant enrolled

November 20, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 5, 2021

Completed
Last Updated

May 5, 2021

Status Verified

April 1, 2021

Enrollment Period

4 months

First QC Date

April 20, 2021

Last Update Submit

May 4, 2021

Conditions

Dyslipidemias

Outcome Measures

Primary Outcomes (2)

  • Pharmacokietic parameters administration: Cmax

    YYC506-T, YYC506-A, and concomitant administration Cmax

    Until 48 hours

  • Pharmacokietic parameters administration: AUC

    YYC506-T, YYC506-A, and concomitant administration AUC

    Until 48 hours

Study Arms (2)

A Group

EXPERIMENTAL

Two cohort, single sequence

Drug: YYC506-TDrug: YYC506-T + YYC506-A

B Group

EXPERIMENTAL

Two cohort, single sequence

Drug: YYC506-ADrug: YYC506-A + YYC506-T

Interventions

YYC506-TDRUG

single administration

A Group
YYC506-ADRUG

single administration

B Group
YYC506-T + YYC506-ADRUG

concomotant administration

A Group
YYC506-A + YYC506-TDRUG

concomotant administration

B Group

Eligibility Criteria

Age19 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 19 ages healty men
  • Over 50.0kg, 18.0kg/m2 ≤ BMI ≤30.0kg/m2
  • Men who dont have congenital disease and other cronic disease need to be cared etc.

You may not qualify if:

  • Men who have congenital liver disease (AST, ALT, CK ≥ 2X ULN)
  • Men who have drunken or eatten something including carffeine within 24 hours before etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ChungBuk National University Hospital

Cheongju-si, South Korea

Location

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Min Kyu Park, PhD

    ChungBuk National Unviersity Hospital.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: two-cohort, single-sequence, parallel, open label, multiple oral dosing study.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2021

First Posted

May 5, 2021

Study Start

November 20, 2019

Primary Completion

March 23, 2020

Study Completion

March 23, 2020

Last Updated

May 5, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)