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

• Sponsor: Chong Kun Dang Pharmaceutical (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05108038
• Collaborator: (none)
• Enrollment: 42
• Location: 1
• Arms: 6
• Anticipated Duration (Months): 3.8
• Patients Per Site Per Month: 10.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
GERD	Drug: CKD-382, D860, D027	Phase 1

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Oct 7, 2021
• Anticipated Primary Completion Date: Feb 1, 2022
• Anticipated Study Completion Date: Feb 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Primary Pharmacokinetic Endpoint [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]

   AUCt,ss Evaluation after multiple dose -AUCt,ss: Area under the plasma drug concentration-time curve within a dosing interval in steady-state

2. Primary Pharmacodynamic Endpoint [24 hours after multiple dose for 7 days compared to baseline]

   Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose

Secondary Outcome Measures

1. (1) Secondary Pharmacokinetic Endpoint [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]

   Cmax,ss Evaluation after multiple dose -Cmax,ss: Maximum concentration of drug in plasma

2. (1) Secondary Pharmacokinetic Endpoint [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]

   Tmax,ss Evaluation after multiple dose -Tmax,ss: Time to maximum plasma concentration

3. (1) Secondary Pharmacokinetic Endpoint [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]

   t1/2ss Evaluation after multiple dose -t1/ss: Terminal elimination half life in steady state

4. (1) Secondary Pharmacokinetic Endpoint [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]

   CLss/F Evaluation after multiple dose -CLss/F: Apparent Clearance in steady-state

5. (1) Secondary Pharmacokinetic Endpoint [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]

   Vzss/F Evaluation after multiple dose -Vzss/F: Apparent Volume of Distribution at steady state

6. (1) Secondary Pharmacokinetic Endpoint [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]

   R Evaluation after multiple dose -R: Accumulation ratio

7. (1) Secondary Pharmacokinetic Endpoint [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]

   PTF Evaluation after multiple dose -PTF: Peak to Trough Fluctuation

8. (2) Secondary Pharmacokinetic Endpoint [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]

   Cmax Evaluation after single dose -Cmax: Maximum concentration of drug in plasma

9. (2) Secondary Pharmacokinetic Endpoint [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]

   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

10. (2) Secondary Pharmacokinetic Endpoint [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]

    Tmax Evaluation after single dose -Tmax: Time to maximum plasma concentration

11. (2) Secondary Pharmacokinetic Endpoint [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]

    t1/2 Evaluation after single dose -t1/2: Terminal elimination half-life

12. (2) Secondary Pharmacokinetic Endpoint [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]

    CL/F Evaluation after single dose -CL/F: Apparent Clearance

13. (2) Secondary Pharmacokinetic Endpoint [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]

    Vz/F Evaluation after single dose -Vz/F: Apparent Volume of Distribution

14. (1) Secondary Pharmacodynamic Endpoint [24 hours after first dose compared to baseline]

    Percent decrease from baseline in integrated gastric acidity for 24-hour interval after first dose

15. (2) Secondary Pharmacodynamic Endpoint [24 hours after first dose and multiple dose for 7 days]

    Percent of time with gastric pH≤4 for 24-hour interval after first or 7th dose

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chungbuk Ntional University Hospital	Cheongju-si		Korea, Republic of

Sponsors and Collaborators

• Chong Kun Dang Pharmaceutical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chong Kun Dang Pharmaceutical
• ClinicalTrials.gov Identifier: NCT05108038
• Other Study ID Numbers: A105_02PK2115
• First Posted: Nov 4, 2021
• Last Update Posted: Nov 4, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Chong Kun Dang Pharmaceutical: CKD-382; D860; D027

Study Results

No Results Posted as of Nov 4, 2021