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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (SAD) IY-828026 10 mg | Experimental | Paritipants will receive single oral administration of IY-828026 10 mg or Placebo comparator |
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| (SAD) IY-828026 20 mg | Experimental | Paritipants will receive single oral administration of IY-828026 20 mg or Placebo comparator |
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| (SAD) IY-828026 40 mg | Experimental | Period 1: Paritipants will receive single oral administration of IY-828026 40 mg or Placebo comparator (Fast) Period 2: Paritipants will receive single oral administration of IY-828026 40 mg or Placebo comparator (Fed) |
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| (SAD) IY-828026 80 mg | Experimental | Paritipants will receive single oral administration of IY-828026 80 mg or Placebo comparator |
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| (SAD) IY-828026 160 mg | Experimental | Paritipants will receive single oral administration of IY-828026 160 mg or Placebo comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IY-828026 | Drug | IY-828026 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| YunSeon Kim | Contact | 82-70-7165-7319 | yskim@ilyang.co.kr |
| Name | Affiliation | Role |
|---|---|---|
| Shin | Ilyang Pharmaceutical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
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| (MAD) IY-828026 20 mg | Experimental | Participants will receive oral administration of IY-828026 20 mg once daily for 7 days |
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| (MAD) IY-828026 40 mg | Experimental | Participants will receive oral administration of IY-828026 40 mg once daily for 7 days |
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| (MAD) IY-828026 80 mg | Experimental | Participants will receive oral administration of IY-828026 80 mg once daily for 7 days |
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| (MAD) IY-828026A | Active Comparator | Participants will receive oral administration of IY-828026A 40mg once daily for 7 days |
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| (MAD) IY-828026B | Active Comparator | Participants will receive oral administration of IY-828026B 50mg once daily for 7 days |
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| Placebo | Drug | Placebo comparator |
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| IY-828026A | Drug | Active comparator |
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| IY-828026B | Drug | Active comparator |
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| 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: 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) | 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 | 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 | 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: 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) | 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: 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) | 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) |
| 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 | 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 | 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] | 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] | 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] | 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] | 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 |