NCT04874129

Brief Summary

To evaluate the safety and pharmacokinetics characteristics between YYC506 and concomitant administration of YYC506-T and YYC506-A

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2021

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

January 7, 2021

Completed
3 months 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
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

May 5, 2021

Status Verified

April 1, 2021

Enrollment Period

5 months

First QC Date

April 20, 2021

Last Update Submit

May 4, 2021

Conditions

Dyslipidemias

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetic parameters: Cmax

    Cmax

    Until 48 hours

  • Pharmacokinetic parameters: AUC

    YYC506-T, YYC506-A, YYC506 AUC

    Until 48 hours

Study Arms (2)

A Group

OTHER

Two-way Crossover

Drug: YYC506-T and YYC506-A (phase 1)Drug: YYC506 (phase 2)

B Group

OTHER

Two-way Crossover

Drug: YYC506 (phase 1)Drug: YYC506-T and YYC506-A (phase 2)

Interventions

YYC506-T and YYC506-A (phase 1)DRUG

Comparator

Also known as: Comparator
A Group
YYC506 (phase 1)DRUG

Test

Also known as: Test
B Group
YYC506-T and YYC506-A (phase 2)DRUG

Comparator

Also known as: Comparator
B Group
YYC506 (phase 2)DRUG

Test

Also known as: Test
A Group

Eligibility Criteria

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

You may qualify if:

  • Over 19 ages healthy men
  • Over 50.0kg, 18.0kg/m2 ≤ BMI ≤ 30.0kg/m2
  • Men who don't 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 caffeine within 24 hours before. etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chungbuk National Unviersity Hosipital

Cheongju-si, South Korea

Location

MeSH Terms

Conditions

Dyslipidemias

Interventions

Clinical Trials, Phase I as TopicClinical Trials, Phase II as Topic

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Clinical Trials as TopicClinical Studies as TopicEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Min Kyu Park, PhD

    Chungbuk National University Hosipital.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: ramdomized, open-label, single-dose, two-way crossover study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2021

First Posted

May 5, 2021

Study Start

January 7, 2021

Primary Completion

May 31, 2021

Study Completion

July 31, 2021

Last Updated

May 5, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)