NCT04304547

Brief Summary

Phase I clinical trial to compare the pharmacokinetics and safety of CKD-348 with co-administration of CKD-828, D097 and D337 in healthy adult volunteers

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Feb 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

Study Start

First participant enrolled

February 4, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 9, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 11, 2020

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2020

Completed
Last Updated

August 13, 2020

Status Verified

March 1, 2020

Enrollment Period

2 months

First QC Date

March 9, 2020

Last Update Submit

August 12, 2020

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Cmax

    Maximum plasma concentration of the drug

    0 hour ~ 144 hr

  • AUCt

    Area under the concentration time curve from time zero to time

    0 hour ~ 144 hour

Study Arms (3)

Sequence A

ACTIVE COMPARATOR

CKD-828, D097, D337, CKD-348 T1, CKD-348 T2

Drug: CKD-828, D097, D337, CKD-348 T1, CKD-348 T2

Sequence B

ACTIVE COMPARATOR

CKD-828, D097, D337, CKD-348 T1, CKD-348 T2

Drug: CKD-348 T1, CKD-348 T2, CKD-828, D097, D337,

Sequence C

ACTIVE COMPARATOR

CKD-828, D097, D337, CKD-348 T1, CKD-348 T2

Drug: CKD-348 T2, CKD-348 T1, CKD-828, D097, D337

Interventions

CKD-828, D097, D337, CKD-348 T1, CKD-348 T2DRUG

Subject of sequence A takes IP in the following order: 1. Each tablet of CKD-828 and D097 and D337 be taken at once 2. CKD-348 T1 1 tablet 3. CKD-348 T2 1 tabet

Also known as: Sequence A
Sequence A
CKD-348 T1, CKD-348 T2, CKD-828, D097, D337,DRUG

Subject of sequence B takes IP in the following order: 1. CKD-348 T1 1 tablet 2. CKD-348 T2 1 tablet 3. Each tablet of CKD-828 and D097 and D337 be taken at once

Also known as: Sequence B
Sequence B
CKD-348 T2, CKD-348 T1, CKD-828, D097, D337DRUG

Subject of sequence C takes IP in the following order: 1. CKD-348 T2 1 tablet 2. Each tablet of CKD-828 and D097 and D337 be taken at once 3. CKD-348 T1 1 tablet

Also known as: Sequence C
Sequence C

Eligibility Criteria

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

You may qualify if:

  • ≤ age ≤ 45
  • Health Volunteers
  • Subject who agreeds to participate in this clinical trial voluntarily

You may not qualify if:

  • \. Subject who cannot participate in a clinical trial based on the PI's judgment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Location

Study Officials

  • Jae Yong Chung

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 9, 2020

First Posted

March 11, 2020

Study Start

February 4, 2020

Primary Completion

April 2, 2020

Study Completion

April 2, 2020

Last Updated

August 13, 2020

Record last verified: 2020-03

Locations

KR(1)