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NCT05108038 Clinical Trial

A Study to Evaluate the PK, PD and Safety of CKD-382 in Healthy Subjects

GERD Clinical Trial

Official title:
A Randomized, Open-label, Crossover Phase 1 Clinical Trial to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety After Single/Multiple Administration of CKD-382, D860 and D027 in Healthy Subjects

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05108038
Other study ID # A105_02PK2115
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date October 7, 2021
Est. completion date February 2022

Study information
Verified date October 2021
Source Chong Kun Dang Pharmaceutical
Contact Minkyu Park, Ph.D
Phone 043-269-8708
Email mk_park@cbnuhctc.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

to evaluate the pharmacokinetics, pharmacodynamics and safety after single/multiple administration of CKD-382, D860 and D027 in healthy subjects

Description:

A randomized, open-label, crossover phase 1 clinical trial to evaluate the pharmacokinetics, pharmacodynamics and safety after single/multiple administration of CKD-382, D860 and D027 in healthy subjects

Recruitment information / eligibility
Status Recruiting
Enrollment 42
Est. completion date February 2022
Est. primary completion date February 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 50 Years
Eligibility Inclusion Criteria: - Between 19 aged and 50 aged in healthy adult - Body weight more than 50kg - BMI more than 18.0 and under 27.0 - Who has negative result on Helicobacter Pylori antibody test Exclusion Criteria: - Have clinically significant disease that hepatobiliary system, kidney, nervous system, immune system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular system or mental illness, or a history of mental disease - Have a gastrointestinal disease history(including surgery) that can effect drug absorption - Hypersensitivity reaction of clinically significant hypersensitivity reaction in the history of Esomeprazole, additives or benzimidazole family

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• CKD-382, D860, D027
QD, PO for 7days

Locations
Country Name City State
Korea, Republic of Chungbuk Ntional University Hospital Cheongju-si

Sponsors (1)
Lead Sponsor Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Primary Pharmacokinetic Endpoint AUCt,ss Evaluation after multiple dose
-AUCt,ss: Area under the plasma drug concentration-time curve within a dosing interval in steady-state		 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
Primary Primary Pharmacodynamic Endpoint Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose 24 hours after multiple dose for 7 days compared to baseline
Secondary (1) Secondary Pharmacokinetic Endpoint Cmax,ss Evaluation after multiple dose
-Cmax,ss: Maximum concentration of drug in plasma		 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
Secondary (1) Secondary Pharmacokinetic Endpoint Tmax,ss Evaluation after multiple dose
-Tmax,ss: Time to maximum plasma concentration		 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
Secondary (1) Secondary Pharmacokinetic Endpoint t1/2ss Evaluation after multiple dose
-t1/ss: Terminal elimination half life in steady state		 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
Secondary (1) Secondary Pharmacokinetic Endpoint CLss/F Evaluation after multiple dose
-CLss/F: Apparent Clearance in steady-state		 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
Secondary (1) Secondary Pharmacokinetic Endpoint Vzss/F Evaluation after multiple dose
-Vzss/F: Apparent Volume of Distribution at steady state		 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
Secondary (1) Secondary Pharmacokinetic Endpoint R Evaluation after multiple dose
-R: Accumulation ratio		 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
Secondary (1) Secondary Pharmacokinetic Endpoint PTF Evaluation after multiple dose
-PTF: Peak to Trough Fluctuation		 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
Secondary (2) Secondary Pharmacokinetic Endpoint Cmax Evaluation after single dose
-Cmax: Maximum concentration of drug in plasma		 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
Secondary (2) Secondary Pharmacokinetic Endpoint AUC0-t Evaluation after single dose
-AUC0-t: Area under the plasma concentration-time curve from the point of administration to last time point of blood sampling		 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
Secondary (2) Secondary Pharmacokinetic Endpoint Tmax Evaluation after single dose
-Tmax: Time to maximum plasma concentration		 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
Secondary (2) Secondary Pharmacokinetic Endpoint t1/2 Evaluation after single dose
-t1/2: Terminal elimination half-life		 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
Secondary (2) Secondary Pharmacokinetic Endpoint CL/F Evaluation after single dose
-CL/F: Apparent Clearance		 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
Secondary (2) Secondary Pharmacokinetic Endpoint Vz/F Evaluation after single dose
-Vz/F: Apparent Volume of Distribution		 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
Secondary (1) Secondary Pharmacodynamic Endpoint Percent decrease from baseline in integrated gastric acidity for 24-hour interval after first dose 24 hours after first dose compared to baseline
Secondary (2) Secondary Pharmacodynamic Endpoint Percent of time with gastric pH=4 for 24-hour interval after first or 7th dose 24 hours after first dose and multiple dose for 7 days
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