Clinical Trials Logo
  1. Home
  2. GERD
  3. NCT05108038
  4. Details
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
See also
  Status Clinical Trial Phase
Recruiting NCT06084572 - Prospective Evaluation of pH-impedance Tracings According to the Wingate Consensus, and Influence on GERD Classification According to the Lyon Consensus
Completed NCT03568825 - Response Surface Pathway Design With Two Interventional- and One Response Variable in Estimating Minimum Efficacy Dose N/A
Recruiting NCT04703374 - A Study to Compare PK, PD and Safety of CKD-382 in Healthy Subjects Phase 1
Completed NCT04120025 - Effectiveness of Diaphragmatic Breathing on Reflux Symptoms in Outpatients N/A
Withdrawn NCT04771247 - Endoscopic Cardiac Band Ligation for the Management of Refractory GERD After Laparoscopic Sleeve Gastrectomy N/A
Completed NCT02575287 - Minimal Injuries From Esophagus Detected by Optical Enhancement System™ Associated to Optical Magnification HD Scopes N/A
Completed NCT01710800 - Twenty-Four Hour Combined Multi-Channel Impedance and pH Ambulatory Monitoring: Impedance Reflux Episodes of Patients On and Off Proton Pump Inhibitor Therapy N/A
Completed NCT00287339 - The Utility of Nexium in Chronic Cough and Reflux Disease Phase 4
Completed NCT00287391 - Sleep Disorders and Gastroesophageal Reflux Disease (GERD) Phase 4
Completed NCT00629564 - An Open, Randomized, Two Way Crossover Study Comparing the Effect of 20mg Esomeprazole Administered Orally and Intravenously as a 15 Minute Infusion on Basal and Pentagastrin-Stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD) Phase 4
Completed NCT04243668 - ANTI REFLUX MUCOSAL ABLATION THERAPHY (ARMA) N/A
Completed NCT03558477 - PK/PD Clinical Trial of YYD601 in Healthy Adult Male Phase 1
Recruiting NCT05042063 - Acoustic Cough Monitoring for the Management of Patients With Known Respiratory Disease
Completed NCT05069493 - Long-term Follow-up After Hiatal Hernia Repair by Tension-free Mesh Closure or Simple Suturing
Completed NCT03238534 - Efficacy and Safety Evaluation of Neobianacid® in GERD and EPS Phase 4
Recruiting NCT05974722 - Mesh Vs Pledgets for Repair of Paraesophageal Hernia N/A
Recruiting NCT05781347 - Stretta Versus Conservative Treatment in Obese and Non-obese N/A
Completed NCT06141577 - A Study to Compare Pharmacokinetics, Pharmacodynamics and Safety of UI059 and UIC202201 in Healthy Subjects Phase 1
Recruiting NCT02587910 - Melanole, a Dietary Supplement, for the Treatment of Gastroesophageal Reflux Disease Phase 2/Phase 3
Suspended NCT02142998 - A Prospective Blinded Randomized Study Comparing Laparoscopic Sleeve Gastrectomy and Laparoscopic Roux-en-y Gastric Bypass and Their Effect on Gastro-Esophageal Reflux Disease Using 24 Horus pH Monitoring N/A