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A Study to Evaluate Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of IN-C005 in Healthy Male Subjects

Healthy Clinical Trial

Official title:
An Open-label, Randomized, Single and Multiple Dosing Phase I Clinical Trial to Evaluate Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of IN-C005 After Oral Administration in Healthy Korean and Caucasian Male Subjects

Clinical Trial Summary

The main purpose of this study is to evaluate pharmacokinetics/pharmacodynamics and safety/tolerability of IN-C005 after oral administration in healthy Korean and Caucasian male subjects.

Clinical Trial Description

[Pharmacokinetic Assessments]: Plasma concentrations of IN-C005 and its metabolite will be measured 1. Single Dosing Group (Korean Subjects) - Primary endpoints: Cmax and AUClast of IN-C005 - Secondary endpoints: AUClast, Cmax, AUCinf, Tmax, t½, CL/F, and Vd/F of M1; AUCinf, Tmax, t½, CL/F, and Vd/F of IN-C005 2. Multiple Dosing Group (Caucasian Subjects) - Primary endpoints: Cmax, AUClast, Cmax,ss, and AUCτ,ss of IN-C005 - Secondary endpoints: For M1, AUClast, Cmax, Cmax,ss, AUCinf, AUCτ,ss, Tmax, Tmax,ss, t½, CL/F, and Vd/F; for IN-C005, AUCinf, Tmax, Tmax,ss, Cmin,ss, t½, CL/F, Vd/F, Cav,ss, CLss/F, Vss/F, PTF (peak to trough fluctuation), and R (accumulation ratio) [Pharmacodynamic Assessments]: 1. Single Dosing Group (Korean Subjects) - Intragastric pH - Percent (%) duration of pH ≥4 in 24 hrs - Mean pH - Median pH - Change in pH from baseline to post-dose (Δduration %, Δmean pH, Δmedian pH, etc.) - Serum gastrin level - AUEGlast - Gmax - Change in gastrin level from baseline to study treatment (1d, 8d, and 15d)(ΔAUEGlast, ΔGmax, etc.) 2. Multiple Dosing Group (Caucasian Subjects) - Intragastric pH - Percent (%) duration of pH ≥4 in 24 hrs - Mean pH - Median pH - Change in pH from baseline to post-single dose and post-multiple doses (Δduration %, Δmean pH, Δmedian pH, etc.) - Serum gastrin level - AUEGlast - Gmax - Change in gastrin level from baseline to 1d and 7d (ΔAUEGlast, ΔGmax, etc.) [Safety Assessments] <Single Dosing Group (Korean Subjects) and Multiple Dosing Group (Caucasian Subjects)> 1. AEs will be monitored with observable/objective symptoms, etc. 2. Physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04485884
Study type Interventional
Source HK inno.N Corporation
Contact Youngshin Keum, R.Ph, Pharm.D
Phone +82-2-6477-0204
Email ys.keum@inno-n.com
Status Recruiting
Phase Phase 1
Start date August 13, 2020
Completion date June 2021
View Details
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