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

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

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

Study Overview

• Status: Recruiting
• Conditions: GERD
• Intervention / Treatment: Drug: CKD-382, D860, D027

Detailed 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

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Cheongju-si, Korea, Republic of
    • Recruiting
    • Chungbuk Ntional University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; Period 1: CKD-382 Period 2: D860 Period 3: D027	Drug: CKD-382, D860, D027; QD, PO for 7days
Experimental: B; Period 1: CKD-382 Period 2: D027 Period 3: D860	Drug: CKD-382, D860, D027; QD, PO for 7days
Experimental: C; Period 1: D860 Period 2: D027 Period 3: CKD-382	Drug: CKD-382, D860, D027; QD, PO for 7days
Experimental: D; Period 1: D860 Period 2: CKD-382 Period 3: D027	Drug: CKD-382, D860, D027; QD, PO for 7days
Experimental: E; Period 1: D027 Period 2: D860 Period 3: CKD-382	Drug: CKD-382, D860, D027; QD, PO for 7days
Experimental: F; Period 1: D027 Period 2: CKD-382 Period 3: D860	Drug: CKD-382, D860, D027; QD, PO for 7days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
(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
(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
(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
(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
(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
(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
(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
(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
(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
(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
(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
(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
(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
(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
(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

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2021
• Primary Completion (Anticipated): February 1, 2022
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: October 14, 2021
• First Submitted That Met QC Criteria: October 24, 2021
• First Posted (Actual): November 4, 2021

Study Record Updates

• Last Update Posted (Actual): November 4, 2021
• Last Update Submitted That Met QC Criteria: October 24, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: CKD-382; D860; D027
• Other Study ID Numbers: A105_02PK2115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No