| Primary | Safety and Tolerability of AZD5718 by Assessment of the Number of Participants With Adverse Events Following Oral Administration of SAD (Part A) and MAD (Part B). | To assess the safety and tolerability of AZD5718 following oral administration of SAD (Part A) and MAD (Part B). | All randomized subjects who received at least 1 dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study. | Posted | | Number | | Participants | | From screening to last followup visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B) | | | | ID | Title | Description |
|---|
| OG000 | Part A (Amorphous Suspension) | Participants received single dose of oral suspension of AZD5718 in amorphous state at dose levels 25 mg, 50 mg, 100 mg, 300 mg, 600 mg & 1200mg with 6 participants in each dose level | | OG001 | Part A (Crystalline Suspension) | Participants received single dose of oral suspension of AZD5718 in crystalline state at dose levels 100 mg & 300 mg with 6 participants in each dose level | | OG002 | Part B (Amorphous Suspension) | Participants received multiple daily doses of oral suspension of AZD5718 in amorphous state at dose levels 60 mg, 180 mg, 360 mg & 600 mg with 6 participants in each dose level | | OG003 | Placebo - Part A (Amorphous Suspension) | 2 participants per dose level received single dose of placebo in Part A (Amorphous suspension) | | OG004 | Placebo - Part A (Crystalline Suspension) | 2 participants per dose level received single dose of placebo in Part A (Crystalline suspension) | | OG005 | Placebo - Part B (Amorphous Suspension) | 2 participants per dose level received single dose of placebo in Part B (Amorphous suspension) |
| | Units | Counts |
|---|
| Participants | - OG00036
- OG00112
- OG00224
- OG003
|
| | Title | Denominators | Categories |
|---|
| Any AE | | | Title | Measurements |
|---|
| - OG00015
- OG0012
- OG00210
- OG003
|
|
| |
| Secondary | Rate and Extent of Absorption of AZD5718 by Assessment of the Area Under the Plasma Concentration-curve From Time Zero Extrapolated to Infinity (AUC) for Part A - Amorphous and Crystalline Suspension | To assess area under the concentration-time curve from time zero extrapolated to infinity and was estimated by AUC(0-last) + Clast/λz (Clast - the last observed quantifiable concentration) following a single administration of AZD5718 Amorphous and Crystalline suspension (Part A only) | All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*nmol/L | | At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose) (Part A only) | | | | ID | Title | Description |
|---|
| OG000 | 25 mg - Part A (Amorphous Suspension) | Participants received single dose of oral suspension of AZD5718 25 mg in amorphous state | | OG001 | 50 mg - Part A (Amorphous Suspension) | Participants received single dose of oral suspension of AZD5718 50 mg in amorphous state | | OG002 | 100 mg - Part A (Amorphous Suspension) | |
|
| Secondary | Rate and Extent of Absorption of AZD5718 by Assessment of the Area Under Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC) for Part B - Amorphous Suspension | To assess the rate and extent of absorption of AZD5718 by evaluation of the area under plasma concentration-time curve from time zero extrapolated to infinity (AUC) following a single AZD5718 dose on Day 1 and multiple daily dosing on Days 9 or 10 under fasted conditions (Part B) | All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*nmol/L | | Day 1 of Part B | | | | ID | Title | Description |
|---|
| OG000 | 60 mg - Part B (Amorphous Suspension) | Participants received multiple doses of oral suspension of AZD5718 60 mg in amorphous state in 6 cohorts | | OG001 | 180 mg - Part B (Amorphous Suspension) | Participants received multiple doses of oral suspension of AZD5718 180 mg in amorphous state in 6 cohorts | | OG002 | 360 mg - Part B (Amorphous Suspension) | Participants received multiple doses of oral suspension of AZD5718 360 mg in amorphous state in 6 cohorts |
|
| Secondary | Rate and Extent of Absorption of AZD5718 by Assessment of the Area Under the Plasma Concentration-curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-last)) for Part A - Amorphous and Crystalline Suspension | To assess area under the area under the plasma concentration-curve from time zero to the time of last quantifiable concentration (AUC(0-last)) following a single administration of AZD5718 Amorphous and Crystalline suspension (Part A only) | All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*nmol/L | | At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose) (Part A only) | | | | ID | Title | Description |
|---|
| OG000 | 25 mg - Part A (Amorphous Suspension) | Participants received single dose of oral suspension of AZD5718 25 mg in amorphous state | | OG001 | 50 mg - Part A (Amorphous Suspension) | Participants received single dose of oral suspension of AZD5718 50 mg in amorphous state | | OG002 | 100 mg - Part A (Amorphous Suspension) | |
|
| Secondary | Rate and Extent of Absorption of AZD5718 by Assessment of the Area Under the Plasma Concentration-curve Over the Dosing Interval (AUC(0-Ï„)) for Part B - Amorphous Suspension | To assess the rate and extent of absorption of AZD5718 by evaluation of the area under the plasma concentration-curve over the dosing interval (AUC(0-Ï„)) following a single AZD5718 dose on Day 1 and multiple daily dosing on Days 9 or 10 under fasted conditions (Part B) | All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*nmol/L | | Day 1, Day 9 and Day 10 of Part B | | | | ID | Title | Description |
|---|
| OG000 | 60 mg - Part B (Amorphous Suspension) | Participants received multiple doses of oral suspension of AZD5718 60 mg in amorphous state in 6 cohorts | | OG001 | 180 mg - Part B (Amorphous Suspension) | Participants received multiple doses of oral suspension of AZD5718 180 mg in amorphous state in 6 cohorts | | OG002 | 360 mg - Part B (Amorphous Suspension) | Participants received multiple doses of oral suspension of AZD5718 360 mg in amorphous state in 6 cohorts |
|
| Secondary | Rate and Extent of Absorption of AZD5718 by Assessment of the Observed Maximum Plasma Concentration (Cmax) for Part A - Amorphous and Crystalline Suspension | To assess observed maximum plasma concentration (Cmax) following a single administration of AZD5718 Amorphous and Crystalline suspension (Part A only) | All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nmol/L | | At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose) (Part A only) | | | | ID | Title | Description |
|---|
| OG000 | 25 mg - Part A (Amorphous Suspension) | Participants received single dose of oral suspension of AZD5718 25 mg in amorphous state | | OG001 | 50 mg - Part A (Amorphous Suspension) | Participants received single dose of oral suspension of AZD5718 50 mg in amorphous state | | OG002 | 100 mg - Part A (Amorphous Suspension) | Participants received single dose of oral suspension of AZD5718 100 mg in amorphous state |
|
| Secondary | Rate and Extent of Absorption of AZD5718 by Assessment of the Observed Maximum Plasma Concentration (Cmax) for Part B - Amorphous Suspension | To assess the rate and extent of absorption of AZD5718 by evaluation of the observed maximum plasma concentration (Cmax) following a single AZD5718 dose on Day 1 and multiple daily dosing on Days 9 or 10 under fasted conditions (Part B) | All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nmol/L | | Day 1, Day 9 and Day 10 (Part B only) | | | | ID | Title | Description |
|---|
| OG000 | 60 mg - Part B (Amorphous Suspension) | Participants received multiple doses of oral suspension of AZD5718 60 mg in amorphous state in 6 cohorts | | OG001 | 180 mg - Part B (Amorphous Suspension) | Participants received multiple doses of oral suspension of AZD5718 180 mg in amorphous state in 6 cohorts | | OG002 | 360 mg - Part B (Amorphous Suspension) | Participants received multiple doses of oral suspension of AZD5718 360 mg in amorphous state in 6 cohorts |
|
| Secondary | Rate and Extent of Absorption of AZD5718 by Assessment of the Time to Reach the Observed Maximum Plasma Concentration (Tmax) for Part A - Amorphous and Crystalline Suspension | To assess the time to reach the observed maximum plasma concentration (tmax) following a single administration of AZD5718 Amorphous and Crystalline suspension (Part A only) | All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data. | Posted | | Median | Full Range | Hours | | At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose) (Part A only) | | | | ID | Title | Description |
|---|
| OG000 | 25 mg - Part A (Amorphous Suspension) | Participants received single dose of oral suspension of AZD5718 25 mg in amorphous state | | OG001 | 50 mg - Part A (Amorphous Suspension) | Participants received single dose of oral suspension of AZD5718 50 mg in amorphous state | | OG002 | 100 mg - Part A (Amorphous Suspension) | Participants received single dose of oral suspension of AZD5718 100 mg in amorphous state |
|
| Secondary | Rate and Extent of Absorption of AZD5718 by Assessment of the Time to Reach the Observed Maximum Plasma Concentration (Tmax) for Part B - Amorphous Suspension | To assess the rate and extent of absorption of AZD5718 by evaluation of the time to reach the observed maximum plasma concentration (tmax) following a single AZD5718 dose on Day 1 and multiple daily dosing on Days 9 or 10 under fasted conditions (Part B) | All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data. | Posted | | Median | Full Range | Hours | | Day 1, Day 9 and Day 10 (Part B only) | | | | ID | Title | Description |
|---|
| OG000 | 60 mg - Part B (Amorphous Suspension) | Participants received multiple doses of oral suspension of AZD5718 60 mg in amorphous state in 6 cohorts | | OG001 | 180 mg - Part B (Amorphous Suspension) | Participants received multiple doses of oral suspension of AZD5718 180 mg in amorphous state in 6 cohorts | | OG002 | 360 mg - Part B (Amorphous Suspension) | Participants received multiple doses of oral suspension of AZD5718 360 mg in amorphous state in 6 cohorts |
|
| Secondary | Rate and Extent of Absorption of AZD5718 by Assessment of the Half-life Associated With Terminal Slope of a Semi-logarithmic Plasma Concentration-time Curve (t½λz) for Part A - Amorphous and Crystalline Suspension | To assess Rate and extent of absorption of AZD5718 by assessment of the half-life associated with terminal slope of a semi-logarithmic plasma concentration-time curve (t½λz) following a single administration of AZD5718 Amorphous and Crystalline suspension (Part A only) | All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data. | Posted | | Mean | Standard Deviation | Hours | | At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose) (Part A only) | | | | ID | Title | Description |
|---|
| OG000 | 25 mg - Part A (Amorphous Suspension) | Participants received single dose of oral suspension of AZD5718 25 mg in amorphous state | | OG001 | 50 mg - Part A (Amorphous Suspension) | Participants received single dose of oral suspension of AZD5718 50 mg in amorphous state | | OG002 | 100 mg - Part A (Amorphous Suspension) | Participants received single dose of oral suspension of AZD5718 100 mg in amorphous state |
|
| Secondary | Rate and Extent of Absorption of AZD5718 by Assessment of the Half-life Associated With Terminal Slope of a Semi-logarithmic Plasma Concentration-time Curve (t½λz) for Part B - Amorphous Suspension | To assess the rate and extent of absorption of AZD5718 by evaluation of the half-life associated with terminal slope of a semi-logarithmic plasma concentration-time curve (t½λz) following a single AZD5718 dose on Day 1 and multiple daily dosing on Days 9 or 10 under fasted conditions (Part B) | All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data. | Posted | | Mean | Standard Deviation | Hours | | Day 1 and Day 10 (Part B only) | | | | ID | Title | Description |
|---|
| OG000 | 60 mg - Part B (Amorphous Suspension) | Participants received multiple doses of oral suspension of AZD5718 60 mg in amorphous state in 6 cohorts | | OG001 | 180 mg - Part B (Amorphous Suspension) | Participants received multiple doses of oral suspension of AZD5718 180 mg in amorphous state in 6 cohorts | | OG002 | 360 mg - Part B (Amorphous Suspension) | Participants received multiple doses of oral suspension of AZD5718 360 mg in amorphous state in 6 cohorts |
|
| Secondary | Rate and Extent of Absorption of AZD5718 by Assessment of the Apparent Total Body Clearance After Extravascular Administration Estimated as Dose Divided by AUC (CL/F) for Part A - Amorphous and Crystalline Suspension | To assess rate and extent of absorption of AZD5718 by assessment of the apparent total body clearance after extravascular administration estimated as dose divided by AUC (CL/F) following a single administration of AZD5718 Amorphous and Crystalline suspension (Part A only) | All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data. | Posted | | Mean | Standard Deviation | Liters/Hours | | At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose) (Part A only) | | | | ID | Title | Description |
|---|
| OG000 | 25 mg - Part A (Amorphous Suspension) | Participants received single dose of oral suspension of AZD5718 25 mg in amorphous state | | OG001 | 50 mg - Part A (Amorphous Suspension) | Participants received single dose of oral suspension of AZD5718 50 mg in amorphous state | | OG002 | 100 mg - Part A (Amorphous Suspension) | |
|
| Secondary | Rate and Extent of Absorption of AZD5718 by Assessment of the Apparent Total Body Clearance After Extravascular Administration Estimated as Dose Divided by AUC (CL/F) for Part B - Amorphous Suspension | To assess rate and extent of absorption of AZD5718 by assessment of the Rate and extent of absorption of AZD5718 by assessment of CL/F estimated as dose divided by AUC (for Day 1 only) and dose divided by AUCÏ„ on Day 10 following a single AZD5718 dose on Day 1 and multiple daily dosing on Days 9 or 10 under fasted conditions (Part B) | All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data. | Posted | | Mean | Standard Deviation | Liter/Hour | | Day 1 and Day 10 of Part B | | | | ID | Title | Description |
|---|
| OG000 | 60 mg - Part B (Amorphous Suspension) | Participants received multiple doses of oral suspension of AZD5718 60 mg in amorphous state in 6 cohorts | | OG001 | 180 mg - Part B (Amorphous Suspension) | Participants received multiple doses of oral suspension of AZD5718 180 mg in amorphous state in 6 cohorts | | OG002 | 360 mg - Part B (Amorphous Suspension) | Participants received multiple doses of oral suspension of AZD5718 360 mg in amorphous state in 6 cohorts |
|
| Secondary | Rate and Extent of Absorption of AZD5718 by Assessment of the Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F) for Part A - Amorphous and Crystalline Suspension | To assess rate and extent of absorption of AZD5718 by assessment of the apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) following a single administration of AZD5718 Amorphous and Crystalline suspension (Part A only) | All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data. | Posted | | Mean | Standard Deviation | Liters | | At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | 25 mg - Part A (Amorphous Suspension) | Participants received single dose of oral suspension of AZD5718 25 mg in amorphous state | | OG001 | 50 mg - Part A (Amorphous Suspension) | Participants received single dose of oral suspension of AZD5718 50 mg in amorphous state | | OG002 | 100 mg - Part A (Amorphous Suspension) | Participants received single dose of oral suspension of AZD5718 100 mg in amorphous state |
|
| Secondary | To Evaluate the Relative Bioavailability Between the Amorphous and Crystalline Form of AZD5718 (Part A) by Assessment of AUC for Part A - Amorphous and Crystalline Suspension | To assess the relative bioavailability by AUC between the cohort receiving the crystalline suspension and the corresponding data from the cohort receiving the same dose of the amorphous suspension (Part A only). Crystalline suspension was compared to the reference amorphous suspension. Note: Geometric mean ratios for crystalline/amorphous suspensions were calculated | All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data. | Posted | | Geometric Mean | 90% Confidence Interval | h*nmol/L | | At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8,12, 24, 36, and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | 100 mg - AZD5718 | Participants received single dose of oral suspension of AZD5718 100 mg in amorphous/crystalline state | | OG001 | 300 mg - AZD5718 | Participants received single dose of oral suspension of AZD5718 300 mg in amorphous/crystalline state |
| |
| Secondary | To Evaluate the Relative Bioavailability Between the Amorphous and Crystalline Form of AZD5718 (Part A) by Assessment of Cmax for Part A - Amorphous and Crystalline Suspension | To assess the relative bioavailability by Cmax between the cohort receiving the crystalline suspension and the corresponding data from the cohort receiving the same dose of the amorphous suspension (Part A only). Crystalline suspension was compared to the reference amorphous suspension. Note: Geometric mean ratios for crystalline/amorphous suspensions were calculated | All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data. | Posted | | Geometric Mean | 90% Confidence Interval | nmol/L | | At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose) (Part A only) | | | | ID | Title | Description |
|---|
| OG000 | 100 mg AZD5718 | Participants received single dose of oral suspension of AZD5718 100 mg in amorphous/crystalline state | | OG001 | 300 mg - AZD5718 | Participants received single dose of oral suspension of AZD5718 300 mg in amorphous/crystalline state |
| |
| Secondary | Rate and Extent of Absorption of AZD5718 by Assessment of the Accumulation Ratio for AUC(0-Ï„) (RAC AUC(0-Ï„)) for Part B - Amorphous Suspension | To assess rate and extent of absorption of AZD5718 by assessment of the Rate and extent of absorption of AZD5718 by assessment of accumulation ratio for AUC(0-Ï„) (RAC AUC(0-Ï„)) following a single AZD5718 dose on Day 1 and multiple daily dosing on Days 9 or 10 under fasted conditions (Part B) Accumulation ratio calculated as AUC0-Ï„ Day 10/AUC0-Ï„ Day 1 (first dose) for Part B under fasted condition and presented values for Day 10 | All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data. | Posted | | Mean | Full Range | Ratio | | Day 1 and Day 9 (Part B only) | | | | ID | Title | Description |
|---|
| OG000 | 60 mg - Part B (Amorphous Suspension) | Participants received multiple doses of oral suspension of AZD5718 60 mg in amorphous state in 6 cohorts | | OG001 | 180 mg - Part B (Amorphous Suspension) | Participants received multiple doses of oral suspension of AZD5718 180 mg in amorphous state in 6 cohorts | | OG002 | 360 mg - Part B (Amorphous Suspension) | |
|
| Secondary | Rate and Extent of Absorption of AZD5718 by Assessment of the Accumulation Ratio for Cmax (RAC Cmax) for Part B (Amorphous Suspension) Under Fasted Condition | To assess the rate and extent of absorption of AZD5718 by evaluation of accumulation ratio for Cmax (RAC Cmax) following a single AZD5718 dose on Day 1 and multiple daily dosing on Days 9 or 10 under fasted conditions (Part B). Accumulation ratio calculated as Cmax Day 10/Cmax Day 1 (first dose) for Part B under fasted condition. | All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data. | Posted | | Mean | Full Range | Ratio, no units | | Day 1 and Day 9 (Part B only) | | | | ID | Title | Description |
|---|
| OG000 | 60 mg - Part B (Amorphous Suspension) | Participants received multiple doses of oral suspension of AZD5718 60 mg in amorphous state in 6 cohorts | | OG001 | 180 mg - Part B (Amorphous Suspension) | Participants received multiple doses of oral suspension of AZD5718 180 mg in amorphous state in 6 cohorts | | OG002 | 360 mg - Part B (Amorphous Suspension) | Participants received multiple doses of oral suspension of AZD5718 360 mg in amorphous state in 6 cohorts |
|
| Secondary | Rate and Extent of Absorption of AZD5718 by Assessment of the Temporal Change Parameter in Systemic Exposure (TCP) for Part B (Amorphous Suspension) Under Fasted Condition | To assess rate and extent of absorption of AZD5718 by assessment of the temporal change parameter in systemic exposure (TCP) following a single AZD5718 dose on Day 1 and multiple daily dosing on Days 9 or 10 under fasted conditions (Part B). TCP calculated as AUCτDay10/AUCDay 1 and presented values for Day 10 | All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data. | Posted | | Mean | Full Range | Ratio, no units | | At Day 10 (Part B only) | | | | ID | Title | Description |
|---|
| OG000 | 60 mg - Part B (Amorphous Suspension) | Participants received multiple doses of oral suspension of AZD5718 60 mg in amorphous state in 6 cohorts | | OG001 | 180 mg - Part B (Amorphous Suspension) | Participants received multiple doses of oral suspension of AZD5718 180 mg in amorphous state in 6 cohorts | | OG002 | 360 mg - Part B (Amorphous Suspension) | Participants received multiple doses of oral suspension of AZD5718 360 mg in amorphous state in 6 cohorts |
|
| Secondary | Rate and Extent of Absorption of AZD5718 by Assessment of the Effect of Food Following Administration of 180 mg AZD5718 With Food (Part B Day 9) and Fasted (Part B Day 10) | The effect of food was evaluated by the assessment of the PK parameter (Cmax) following multiple daily doses of 180 mg AZD5718 under fasted condition (Part B Day 10) and immediately following a high-fat breakfast (Part B Day 9) | All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nmol/L | | At Day 9 and Day 10 (Part B only) | | | | ID | Title | Description |
|---|
| OG000 | 180mg-Part B (Amorphous Suspension) -Fed State (Day 9) | Participants received multiple doses of oral suspension of AZD5718 60 mg in amorphous state in 6 cohorts under fed condition | | OG001 | 180mg -Part B (Amorphous Suspension) -Fasted State (Day 10) | Participants received multiple doses of oral suspension of AZD5718 180 mg in amorphous state in 6 cohorts under fed condition |
| |
| Secondary | Rate and Extent of Absorption of AZD5718 by Assessment of the Effect of Food Following Administration of 180 mg AZD5718 With Food (Part B Day 9) and Fasted (Part B Day 10) | The effect of food was evaluated by the assessment of the PK parameter (AUC(0-t) following multiple daily doses of 180 mg AZD5718 under fasted condition (Part B Day 10) and immediately following a high-fat breakfast (Part B Day 9) | All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*nmol/L | | At Day 9 and Day 10 (Part B only) | | | | ID | Title | Description |
|---|
| OG000 | 180mg-Part B (Amorphous Suspension) -Fed State (Day 9) | Participants received multiple doses of oral suspension of AZD5718 60 mg in amorphous state in 6 cohorts under fed condition | | OG001 | 180mg -Part B (Amorphous Suspension) -Fasted State (Day 10) | Participants received multiple doses of oral suspension of AZD5718 180 mg in amorphous state in 6 cohorts under fed condition |
| |
| Secondary | Rate and Extent of Absorption of AZD5718 by Assessment of the Effect of Food Following Administration of 180 mg AZD5718 With Food (Part B Day 9) and Fasted (Part B Day 10) | The effect of food was evaluated by the assessment of the PK parameter(tmax) following multiple daily doses of 180 mg AZD5718 under fasted condition (Part B Day 10) and immediately following a high-fat breakfast (Part B Day 9) | All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data. | Posted | | Median | Full Range | Hours | | At Day 9 and Day 10 (Part B only) | | | | ID | Title | Description |
|---|
| OG000 | 180mg-Part B (Amorphous Suspension) -Fed State (Day 9) | Participants received multiple doses of oral suspension of AZD5718 60 mg in amorphous state in 6 cohorts under fed condition | | OG001 | 180mg -Part B (Amorphous Suspension) -Fasted State (Day 10) | Participants received multiple doses of oral suspension of AZD5718 180 mg in amorphous state in 6 cohorts under fed condition |
| |
| Secondary | Rate and Extent of Absorption of AZD5718 by Assessment of Cumulative Amount of Analyte Excreted at the Last Sampling Interval (CumAe0-24) Following a Single Administration of AZD5718 Amorphous and Crystalline Suspension (Part A) | To assess urine PK parameter (CumAe0-24) after a single administration of AZD5718 Amorphous suspension in Part A | All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data. | Posted | | Mean | Standard Deviation | nmol | | Part A pre-dose and pooled intervals up to 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | 25 mg - Part A (Amorphous Suspension) | Participants received single dose of oral suspension of AZD5718 25 mg in amorphous state | | OG001 | 50 mg - Part A (Amorphous Suspension) | Participants received single dose of oral suspension of AZD5718 50 mg in amorphous state | | OG002 | 100 mg - Part A (Amorphous Suspension) | Participants received single dose of oral suspension of AZD5718 100 mg in amorphous state | | OG003 |
|
| Secondary | Rate and Extent of Absorption of AZD5718 by Assessment of Percentage of Dose Excreted Unchanged Into the Urine From 0 to 24 Hours (Cumfe0-24) Following a Single Administration of AZD5718 Amorphous and Crystalline Suspension (Part A) | To assess urine PK parameter (Cumfe0-24) estimated by dividing Ae(0-last) by dose after a single administration of AZD5718 Amorphous suspension in Part A | All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data. | Posted | | Mean | Standard Deviation | Percentage of Dose Excreted | | Part A pre-dose and pooled intervals up to 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | 25 mg - Part A (Amorphous Suspension) | Participants received single dose of oral suspension of AZD5718 25 mg in amorphous state | | OG001 | 50 mg - Part A (Amorphous Suspension) | Participants received single dose of oral suspension of AZD5718 50 mg in amorphous state | | OG002 | 100 mg - Part A (Amorphous Suspension) | Participants received single dose of oral suspension of AZD5718 100 mg in amorphous state |
|
| Secondary | Rate and Extent of Absorption of AZD5718 by Assessment of Renal Clearance (CLR) Following a Single Administration of AZD5718 Amorphous and Crystalline Suspension (Part A) | To assess the urine PK parameter (CLR) after a single administration of AZD5718 Amorphous suspension in Part A | All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data. | Posted | | Mean | Standard Deviation | Liter/hour | | Part A pre-dose and pooled intervals up to 24 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | 25 mg - Part A (Amorphous Suspension) | Participants received single dose of oral suspension of AZD5718 25 mg in amorphous state | | OG001 | 50 mg - Part A (Amorphous Suspension) | Participants received single dose of oral suspension of AZD5718 50 mg in amorphous state | | OG002 | 100 mg - Part A (Amorphous Suspension) | Participants received single dose of oral suspension of AZD5718 100 mg in amorphous state | | OG003 | 300 mg - Part A (Amorphous Suspension) |
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| Secondary | Rate and Extent of Absorption of AZD5718 by Assessment of Cumulative Amount of Analyte Excreted From 0 to 24 Hours (CumAe0-24) Following a Multiple Daily Doses Administration of AZD5718 Amorphous Suspension (Part B Day 9) | To assess the urine PK parameter (CumAe0-24) after a single administration of AZD5718 Amorphous suspension in Part B Day 9 | All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data. | Posted | | Mean | Standard Deviation | nmol | | Part B only, Day 9 at pooled 3 hour intervals until 24 hours post-dose | | | | ID | Title | Description |
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| OG000 | 60 mg - Part B (Amorphous Suspension) | Participants received multiple doses of oral suspension of AZD5718 60 mg in amorphous state in 6 cohorts | | OG001 | 180 mg - Part B (Amorphous Suspension) | Participants received multiple doses of oral suspension of AZD5718 180 mg in amorphous state in 6 cohorts | | OG002 | 360 mg - Part B (Amorphous Suspension) | Participants received multiple doses of oral suspension of AZD5718 360 mg in amorphous state in 6 cohorts | |
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| Secondary | Rate and Extent of Absorption of AZD5718 by Assessment of Percentage of Dose Excreted Unchanged Into the Urine From 0 to 24 Hours (Cumfe0-24) Following a Multiple Daily Doses Administration of AZD5718 Amorphous Suspension (Part B Day 9) | To assess urine PK parameter (Cumfe0-24) estimated by dividing Ae(0-last) by dose after a single administration of AZD5718 Amorphous suspension in Part B Day 9 | All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data. | Posted | | Mean | Standard Deviation | Percentage of Dose Excreted | | Part B only, Day 9 at pooled 3 hour intervals until 24 hours post-dose | | | | ID | Title | Description |
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| OG000 | 60 mg - Part B (Amorphous Suspension) | Participants received multiple doses of oral suspension of AZD5718 60 mg in amorphous state in 6 cohorts | | OG001 | 180 mg - Part B (Amorphous Suspension) | Participants received multiple doses of oral suspension of AZD5718 180 mg in amorphous state in 6 cohorts | | OG002 | 360 mg - Part B (Amorphous Suspension) | Participants received multiple doses of oral suspension of AZD5718 360 mg in amorphous state in 6 cohorts |
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| Secondary | Rate and Extent of Absorption of AZD5718 by Assessment of Renal Clearance (CLR) Following a Multiple Daily Doses Administration of AZD5718 Amorphous Suspension (Part B Day 9) | To assess the urine PK parameter (CLR) after a single administration of AZD5718 Amorphous suspension in Part B Day 9 | All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data. | Posted | | Mean | Standard Deviation | Liter/hour | | Part B only, Day 9 at pooled 3 hour intervals until 24 hours post-dose | | | | ID | Title | Description |
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| OG000 | 60 mg - Part B (Amorphous Suspension) | Participants received multiple doses of oral suspension of AZD5718 60 mg in amorphous state in 6 cohorts | | OG001 | 180 mg - Part B (Amorphous Suspension) | Participants received multiple doses of oral suspension of AZD5718 180 mg in amorphous state in 6 cohorts | | OG002 | 360 mg - Part B (Amorphous Suspension) | Participants received multiple doses of oral suspension of AZD5718 360 mg in amorphous state in 6 cohorts | | OG003 |
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| Secondary | Pharmacodynamic Analysis by ex Vivo Stimulation of Leukotriene B4 (LTB4) Production Using Calcium Ionophore for Part A -Amorphous and Crystalline Suspension | To assess the change from baseline in the ex vivo stimulated LTB4 production using calcium ionophore in venous blood samples following a single administration of AZD5718 Amorphous and Crystalline suspension (Part A only) | All subjects who received at least 1 dose of AZD5718 or placebo and who had at least 1 pre-dose and one post-dose measurement of stimulated LTB4 and who had no major protocol deviations thought to impact on the analysis of the PD data. | Posted | | Median | Full Range | Nanogram/liter (ng/L) | | Admission to 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose (Part A only) | | | | ID | Title | Description |
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| OG000 | 25 mg - Part A (Amorphous Suspension) | Participants received single dose of oral suspension of AZD5718 25 mg in amorphous state | | OG001 | 50 mg - Part A (Amorphous Suspension) | Participants received single dose of oral suspension of AZD5718 50 mg in amorphous state | | OG002 | 100 mg - Part A (Amorphous Suspension) | Participants received single dose of oral suspension of AZD5718 100 mg in amorphous state |
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| Secondary | Pharmacodynamic Analysis by ex Vivo Stimulation of LTB4 Production Using Calcium Ionophore for Part B - Amorphous Suspension | To assess the change from baseline in the ex vivo stimulated LTB4 production using calcium ionophore in venous blood samples following multiple administration of AZD5718 Amorphous suspension (Part B only) | All subjects who received at least 1 dose of AZD5718 or placebo and who had at least 1 pre-dose and one post-dose measurement of stimulated LTB4 and who had no major protocol deviations thought to impact on the analysis of the PD data. | Posted | | Median | Full Range | Nanogram/liter (ng/L) | | Admission, predose and 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose | | | | ID | Title | Description |
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| OG000 | 60 mg - Part B (Amorphous Suspension) | Participants received multiple doses of oral suspension of AZD5718 60 mg in amorphous state in 6 cohorts | | OG001 | 180 mg - Part B (Amorphous Suspension) | Participants received multiple doses of oral suspension of AZD5718 180 mg in amorphous state in 6 cohorts | | OG002 | 360 mg - Part B (Amorphous Suspension) | Participants received multiple doses of oral suspension of AZD5718 360 mg in amorphous state in 6 cohorts |
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