Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of IY-828026 in Healthy Volunteers

Phase 1RecruitingNCT07433556

Il-Yang Pharm. Co., Ltd.86 enrolled

Overview

A randomized, double-blinded, partial-open, placebo/active-controlled, single/multiple dosing, dose escalation phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic characteristics of IY-828026 in healthy adult volunteers

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healhty

Interventions

IY-828026DRUG

IY-828026

PlaceboDRUG

Placebo comparator

IY-828026ADRUG

Active comparator

IY-828026BDRUG

Eligibility

Sex: ALLMin age: 19 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy adult volunteers aged ≥ 19 and ≤ 50 years at screening * Body weight ≥ 50.0 kg to ≤ 90.0 kg and body mass index (BMI) of ≥ 18.5 kg/m2 to ≤ 29.9 kg/m2 at screening * Volunteers who were fully informed of and completely understood this study, voluntarily agreed to participate, and provided written consent to comply with the precautions Exclusion Criteria: * Current or history of clinically significant disease of hepatobiliary (severe hepatic impairment, viral hepatitis, etc.), renal (severe renal impairment, etc.), nervous, immune, respiratory, gastrointestinal, endocrine, hemato-oncologic, cardiovascular (heart failure, torsades de pointes, etc.), urinary, or psychiatric (mood disorder, obsessive compulsory disorder, etc.) system or sexual dysfunctions * H. pylori eradication treatment within 6 months or positive result for H. pylori at screening * Hypersensitivity or history of clinically significant hypersensitivity to PPIs, P-CABs, and other drugs (aspirin, antibiotics, etc.) * A positive result in serology (hepatitis B tests, hepatitis C tests, human immunodeficiency virus \[HIV\] tests, or syphilis tests) * History of drug abuse or positive results for drug abuse in the urine drug screen

Locations (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Number of Participants With Adverse Events

All adverse events occurring during the clinical trial following a single or multiple ascending dose of IY-828026 will be collected and evaluated for seriousness, severity, and their relationship to the investigational product. Events will be coded using MedDRA System Organ Class and Preferred Term. \[Unit of Measure\] Participants

Time frame: Approximately Day 9 for SAD and Day 15 for MAD

Pharmacokinetic Parameters: Maximum Plasma Concentration (Cmax) (SAD)

Cmax will be determined using non-compartmental analysis following a single ascending dose of IY-828026 \[Unit of Measure\] ng/mL

Time frame: Day 1 pre-dose (0hour), and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hour (Day 2), 48 hour (Day 3), and 72hour (Day 4) post-dose

Pharmacokinetic Parameters: Area Under the Concentration-Time Curve (AUC₀-last) (SAD)

AUC₀-t will be calculated using non-compartmental analysis following a single ascending dose of IY-828026 \[Unit of Measure\] ng·h/mL

Time frame: Day 1 pre-dose (0hour), and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hour (Day 2), 48 hour (Day 3), and 72hour (Day 4) post-dose

Pharmacokinetic Parameters: Area Under the Concentration-Time Curve Extrapolated to Infinity (AUCinf) (SAD)

AUCinf will be calculated from the concentration-time curve following a single ascending dose of IY-828026 \[Unit of Measure\] ng·h/mL

Time frame: Day 1 pre-dose (0hour), and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hour (Day 2), 48 hour (Day 3), and 72hour (Day 4) post-dose

Pharmacokinetic Parameters: Time to Maximum Plasma Concentration (Tmax) (SAD)

Tmax will be derived from the plasma concentration-time profile following a single ascending dose of IY-828026

Time frame: Day 1 pre-dose (0hour), and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hour (Day 2), 48 hour (Day 3), and 72hour (Day 4) post-dose

Central Contacts

YunSeon Kim

CONTACT

82-70-7165-7319 yskim@ilyang.co.kr

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Pharmacokinetic Parameters: Terminal Elimination Half-Life (t1/2) (SAD)

Terminal elimination half-life will be estimated from the terminal phase of the concentration-time curve following a single ascending dose of IY-828026 \[Unit of Measure\] Hour (h)

Time frame: Day 1 pre-dose (0hour), and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24 hour (Day 2), 48 hour (Day 3), and 72hour (Day 4) post-dose

Pharmacokinetic Parameters: Maximum Plasma Concentration at Steady State (Cmax,ss) (MAD)

Cmax,ss will be measured at steady state during multiple ascending dosing (Day 1-7). \[Unit of Measure\] ng/mL

Time frame: Day 1 pre-dose (0hour), and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24hour (Day 2), Day 4, Day 5, Day 6, Day 7 0hour, and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24hour (Day 8), 48hour (Day 9), and 72hour (Day 10)

Pharmacokinetic Parameters: Area Under the Concentration-Time Curve Over the Dosing Interval (AUCtau,ss) (MAD)

AUCtau,ss will be calculated at steady state during multiple ascending dosing (Day 1-7) \[Unit of Measure\] ng·h/mL

Pharmacokinetic Parameters: Time to Maximum Concentration at Steady State (Tmax,ss) (MAD)

Tmax,ss will be derived from the plasma concentration-time profile at steady state during multiple ascending dosing (Day 1-7) \[Unit of Measure\] Hour (h)

Pharmacokinetic Parameters: Terminal Elimination Half-Life at Steady State (t1/2,ss) (MAD)

The terminal elimination half-life at steady state will be estimated from the terminal phase of the plasma concentration-time curve during multiple ascending dosing (Day 1-7) \[Unit of Measure\] Hour (h)

Pharmacodynamic Parameters: Gastric pH monitoring (SAD)

Median pH value at specific time points and intervals : Median pH value over 4, 12, 24 hours from the time of administration

Time frame: Day -1 0hour (relative to scheduled administration time on Day 1) to Day -1 24hour, Day1 0hour to Day1 24hour

Pharmacodynamic Parameters: Gastric pH monitoring (MAD)

Median pH value at specific time points and intervals : Median pH value over 4, 12, 24 hours from the time of administration

Time frame: Day -1 0hour (relative to scheduled administration time on Day 1) to Day -1 24hour, Day1 0hour to Day1 24hour, Day7 0hour to 24hour

Pharmacodynamic Parameters: Maximum plasma gastrin concentration (SAD)

Maximum plasma gastrin concentration \[Unit of measure: ng/L\]

Time frame: Day-1 0hour (relative to scheduled administration time on Day1, baseline), 2, 4, 6, 8, and 12hour, Day1 pre-dose (0hour), and 2, 4, 6, 8, 12, and 24hour post-dose

Pharmacodynamic Parameters: Area under the plasma gastrin concentration-time curve to the last blood sampling time after single administration (SAD)

Area under the plasma gastrin concentration-time curve to the last blood sampling time after single administration \[Unit of measure: ng·h/L\]

Time frame: Day-1 0hour (relative to scheduled administration time on Day1, baseline), 2, 4, 6, 8, and 12hour, Day1 pre-dose (0hour), and 2, 4, 6, 8, 12, and 24hour post-dose

Pharmacodynamic Parameters: Maximum plasma gastrin concentration (MAD)

Maximum plasma gastrin concentration \[Unit of measure: ng/L\]

Time frame: Day-1 0hour, 2, 4, 6, 8, and 12hour, Day1 pre-dose (0hour), and 2, 4, 6, 8, 12, and 24hour, Day 4 0hour, Day 7 0hour, and 2, 4, 6, 8, 12, 24hour, 48hour, and 72hour

Pharmacodynamic Parameters: Area under the plasma gastrin concentration-time curve to the last blood sampling time after multiple administration (MAD)

Area under the plasma gastrin concentration-time curve to the last blood sampling time after single administration \[Unit of measure: ng·h/L\]

Time frame: Day-1 0hour, 2, 4, 6, 8, and 12hour, Day1 pre-dose (0hour), and 2, 4, 6, 8, 12, and 24hour, Day 4 0hour, Day 7 0hour, and 2, 4, 6, 8, 12, 24hour, 48hour, and 72hour