NCT04485884

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: HK inno.N Corporation · Industry
• Sex: Male
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	IN-C005 dose A	One time dose of IN-C005 dose A taken orally.
DRUG	IN-C005 dose B	One time dose of IN-C005 dose B taken orally.
DRUG	IN-C005 dose C	One time dose of IN-C005 dose C taken orally.
DRUG	IN-C005 dose D	Oral administration of IN-C005 dose D once daily for 7 days.
DRUG	IN-C005 dose E	Oral administration of IN-C005 dose E once daily for 7 days.
DRUG	IN-C005 dose F	Oral administration of IN-C005 dose F once daily for 7 days.

Timeline

• Start date: 2020-08-13
• Primary completion: 2021-03-01
• Completion: 2021-06-01
• First posted: 2020-07-24
• Last updated: 2020-11-09

Locations

1 site across 1 country: South Korea