| Primary | Part A: Change in Cardiac Index (CI) Measured by Right Heart Catheterization (RHC) From Baseline to End of Intravenous (IV) Infusion at 6 Hours | Cardiac index (CI) is a hemodynamic parameter that relates the cardiac output (CO) from left ventricle in one minute to body surface area (BSA), thus relating heart performance to the body size of the participant. It was measured by RHC. | Full analysis set included all randomized participants, irrespective of whether they received any study treatment. | Posted | | Mean | Standard Deviation | Liter per minute per meter square | | Baseline (within 2 hours prior to start of study treatment administration) up to 6 Hours (end of IV infusion) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1- 0.17 mg/kg/hr APD418 | Participants were administered a single dose of 0.17 milligrams per kilogram per hour (mg/kg/hr) (total dose of 1 mg/kg) APD418 as an intravenous (IV) infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG001 | Cohort 1- Placebo | Participants were administered a single dose of matching placebo as an IV infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG002 | Cohort 2- 0.5 mg/kg/hr APD418 | Participants were administered a single dose of 0.5 mg/kg/hr (total dose of 3 mg/kg) APD418 as an IV infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG003 | Cohort 2- Placebo | Participants were administered a single dose of matching placebo as an IV infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0000.33± 0.660
- OG0010.10± 0.100
- OG0020.25± 0.372
- OG003
|
|
| |
| Secondary | Part A: Change in Stroke Volume (SV), Left Ventricular End-Systolic Volume (LVESV) and Left Ventricular End-Diastolic Volume (LVEDV) Measured by Echocardiogram (ECHO) From Baseline to End of IV Infusion at 6 Hours | SV is the volume of blood pumped from the left ventricle per beat. LVESV is the volume of blood in the left ventricle at the end of contraction and at diastole. LVEDV is the amount of blood in the heart's left ventricle just before the heart contracts. All these parameters were measured by ECHO. | Full analysis set included all randomized participants, irrespective of whether they received any study treatment. Here, 'Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Milliliter | | Baseline (within 2 hours prior to start of study treatment administration) up to 6 Hours (end of IV infusion) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1- 0.17 mg/kg/hr APD418 | Participants were administered a single dose of 0.17 milligrams per kilogram per hour (mg/kg/hr) (total dose of 1 mg/kg) APD418 as an intravenous (IV) infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG001 | Cohort 1- Placebo | Participants were administered a single dose of matching placebo as an IV infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. |
|
| Secondary | Part A: Change in Stroke Volume Index (SVI) Measured by ECHO From Baseline to End of IV Infusion at 6 Hours | SVI was calculated as stroke volume divided by BSA. This was measured by ECHO. | Full analysis set included all randomized participants, irrespective of whether they received any study treatment. Here, 'Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Milliliter per meter square | | Baseline (within 2 hours prior to start of study treatment administration) up to 6 Hours (end of IV infusion) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1- 0.17 mg/kg/hr APD418 | Participants were administered a single dose of 0.17 milligrams per kilogram per hour (mg/kg/hr) (total dose of 1 mg/kg) APD418 as an intravenous (IV) infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG001 | Cohort 1- Placebo | Participants were administered a single dose of matching placebo as an IV infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG002 | Cohort 2- 0.5 mg/kg/hr APD418 | Participants were administered a single dose of 0.5 mg/kg/hr (total dose of 3 mg/kg) APD418 as an IV infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. |
|
| Secondary | Part A: Change in Left Ventricular Ejection Fraction (LVEF) Measured by ECHO From Baseline to End of IV Infusion at 6 Hours | LVEF is the central measure of left ventricular systolic function. LVEF is the fraction of chamber volume ejected in systole (stroke volume) in relation to the volume of the blood in the ventricle at the end of diastole (end-diastolic volume). This was measured by ECHO. | Full analysis set included all randomized participants, irrespective of whether they received any study treatment. | Posted | | Mean | Standard Deviation | Percentage of end diastolic volume | | Baseline (within 2 hours prior to start of study treatment administration) up to 6 Hours (end of IV infusion) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1- 0.17 mg/kg/hr APD418 | Participants were administered a single dose of 0.17 milligrams per kilogram per hour (mg/kg/hr) (total dose of 1 mg/kg) APD418 as an intravenous (IV) infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG001 | Cohort 1- Placebo | Participants were administered a single dose of matching placebo as an IV infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG002 | Cohort 2- 0.5 mg/kg/hr APD418 |
|
| Secondary | Part A: Change in Fractional Shortening (FS) Measured by ECHO From Baseline to End of IV Infusion at 6 Hours | FS was calculated by measuring the percentage reduction in left ventricular diameter during systole. This was measured by ECHO. | Full analysis set included all randomized participants, irrespective of whether they received any study treatment. | Posted | | Mean | Standard Deviation | Percentage | | Baseline (within 2 hours prior to start of study treatment administration) up to 6 Hours (end of IV infusion) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1- 0.17 mg/kg/hr APD418 | Participants were administered a single dose of 0.17 milligrams per kilogram per hour (mg/kg/hr) (total dose of 1 mg/kg) APD418 as an intravenous (IV) infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG001 | Cohort 1- Placebo | Participants were administered a single dose of matching placebo as an IV infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG002 | Cohort 2- 0.5 mg/kg/hr APD418 | Participants were administered a single dose of 0.5 mg/kg/hr (total dose of 3 mg/kg) APD418 as an IV infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. |
|
| Secondary | Part A: Change in Left Ventricular End-Systolic and Left Ventricular End-Diastolic Diameter Measured by ECHO From Baseline to End of IV Infusion at 6 Hours | Left ventricular end-systolic diameter and left ventricular end-diastolic diameter were measured using ECHO. | Full analysis set included all randomized participants, irrespective of whether they received any study treatment. | Posted | | Mean | Standard Deviation | Centimeter (cm) | | Baseline (within 2 hours prior to start of study treatment administration) up to 6 Hours (end of IV infusion) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1- 0.17 mg/kg/hr APD418 | Participants were administered a single dose of 0.17 milligrams per kilogram per hour (mg/kg/hr) (total dose of 1 mg/kg) APD418 as an intravenous (IV) infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG001 | Cohort 1- Placebo | Participants were administered a single dose of matching placebo as an IV infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG002 | Cohort 2- 0.5 mg/kg/hr APD418 | Participants were administered a single dose of 0.5 mg/kg/hr (total dose of 3 mg/kg) APD418 as an IV infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. |
|
| Secondary | Part A: Change in Left Ventricular Global Longitudinal Strain (LVGLS) and Left Ventricular Global Circumferential Strain (LVGCS) Measured by ECHO From Baseline to End of IV Infusion at 6 Hours | Left ventricular global strain is the average strain of the cardiac chamber wall, where LVGLS presents longitudinal shortening as a percentage (change in length as a proportion to baseline length). LVGCS measures the chamber deformation along the circumference of the cardiac wall in a tangential xy-direction and similarly presents the circumferential shortening as a percentage. Both the parameters were measured by ECHO. | Full analysis set included all randomized participants, irrespective of whether they received any study treatment. Here, 'Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows. | Posted | | Mean | Standard Deviation | Percentage | | Baseline (within 2 hours prior to start of study treatment administration) up to 6 Hours (end of IV infusion) | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1- 0.17 mg/kg/hr APD418 | Participants were administered a single dose of 0.17 milligrams per kilogram per hour (mg/kg/hr) (total dose of 1 mg/kg) APD418 as an intravenous (IV) infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG001 | Cohort 1- Placebo | Participants were administered a single dose of matching placebo as an IV infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. |
|
| Secondary | Part A: Change in CI Measured by RHC at 0.5, 1, 2, 3, 4 and 5 Hours During 6 Hour IV Infusion | CI is a hemodynamic parameter that relates the CO from left ventricle in one minute to BSA, thus relating heart performance to the body size of the participant. It was measured by RHC. | Full analysis set included all randomized participants, irrespective of whether they received any study treatment. | Posted | | Mean | Standard Deviation | Liter per minute per meter square | | Baseline (within 2 hours prior to start of study treatment administration), 0.5, 1, 2, 3, 4 and 5 hours of IV infusion | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1- 0.17 mg/kg/hr APD418 | Participants were administered a single dose of 0.17 milligrams per kilogram per hour (mg/kg/hr) (total dose of 1 mg/kg) APD418 as an intravenous (IV) infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG001 | Cohort 1- Placebo | Participants were administered a single dose of matching placebo as an IV infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG002 | Cohort 2- 0.5 mg/kg/hr APD418 | Participants were administered a single dose of 0.5 mg/kg/hr (total dose of 3 mg/kg) APD418 as an IV infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. |
|
| Secondary | Part A: Change in Cardiac Output (CO) Measured by RHC at 0.5, 1, 2, 3, 4, 5 and 6 Hours | Change in CO measured by RHC at 0.5, 1, 2, 3, 4, 5 and 6 hours during the 6-hour IV infusion was reported in this outcome measure. | Full analysis set included all randomized participants, irrespective of whether they received any study treatment. | Posted | | Mean | Standard Deviation | Liter per minute | | Baseline (within 2 hours prior to start of study treatment administration), 0.5, 1, 2, 3, 4, 5 and 6 hours of IV infusion | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1- 0.17 mg/kg/hr APD418 | Participants were administered a single dose of 0.17 milligrams per kilogram per hour (mg/kg/hr) (total dose of 1 mg/kg) APD418 as an intravenous (IV) infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG001 | Cohort 1- Placebo | Participants were administered a single dose of matching placebo as an IV infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG002 | Cohort 2- 0.5 mg/kg/hr APD418 | Participants were administered a single dose of 0.5 mg/kg/hr (total dose of 3 mg/kg) APD418 as an IV infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. |
|
| Secondary | Part A: Change in Pulmonary Capillary Wedge Pressure (PCWP), Right Atrial Pressure (RAP), Systolic Pulmonary Arterial Pressure/Diastolic Pulmonary Arterial Pressure (PAS/PAD) Measured by RHC at 0.5, 1, 2, 3, 4, 5 and 6 Hours | PCWP estimated the left atrial pressure and was the pressure measured by wedging a pulmonary artery catheter with an inflated balloon into a small pulmonary arterial branch. PCWP was assessed by 2 successive measurements at least 10 minutes apart. RAP is the blood pressure in the right atrium of the heart. Change in PCWP, RAP, PAS/PAD at 0.5, 1, 2, 3, 4, 5 and 6 hours during the 6-hour IV infusion was reported in this outcome measure. All the parameters were measured by RHC. | Full analysis set included all randomized participants, irrespective of whether they received any study treatment. All participants reported under 'Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' (n) signifies number of participants evaluable for specified timepoints. | Posted | | Mean | Standard Deviation | Millimeters of mercury | | Baseline (within 2 hours prior to start of study treatment administration), 0.5, 1, 2, 3, 4, 5 and 6 hours of IV infusion | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1- 0.17 mg/kg/hr APD418 | Participants were administered a single dose of 0.17 milligrams per kilogram per hour (mg/kg/hr) (total dose of 1 mg/kg) APD418 as an intravenous (IV) infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG001 |
|
| Secondary | Part A: Change in Pulmonary Artery Pulsatility Index (PAPi) Measured by RHC at 0.5, 1, 2, 3, 4, 5 and 6 Hours | PAPi is a hemodynamic parameter that is derived from right atrial and pulmonary artery pulse pressures. PAPi = (PAS - PAD)/right atrial pressure. Change in PAPi measured by RHC at 0.5, 1, 2, 3, 4, 5 and 6 hours during the 6-hour IV infusion was reported in this outcome measure. | Full analysis set included all randomized participants, irrespective of whether they received any study treatment. All participants reported under 'Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' (n) signifies number of participants evaluable for specified timepoints. | Posted | | Mean | Standard Deviation | Ratio | | Baseline (within 2 hours prior to start of study treatment administration), 0.5, 1, 2, 3, 4, 5 and 6 hours of IV infusion | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1- 0.17 mg/kg/hr APD418 | Participants were administered a single dose of 0.17 milligrams per kilogram per hour (mg/kg/hr) (total dose of 1 mg/kg) APD418 as an intravenous (IV) infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG001 | Cohort 1- Placebo | Participants were administered a single dose of matching placebo as an IV infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. |
|
| Secondary | Part A: Change in Systemic Vascular Resistance Measured by RHC at 0.5, 1, 2, 3, 4, 5 and 6 Hours | Systemic vascular resistance (SVR) is the amount of force exerted on circulating blood by the vasculature of the body. SVR was calculated as 80*(mean arterial pressure - mean venous pressure) divided by cardiac output. Change in SVR measured by RHC at 0.5, 1, 2, 3, 4, 5 and 6 hours during the 6-hour IV infusion was reported in this outcome measure. | Full analysis set included all randomized participants, irrespective of whether they received any study treatment. All participants reported under 'Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' (n) signifies number of participants evaluable for specified timepoints. | Posted | | Mean | Standard Deviation | Millimeter of mercury*minutes/milliliter | | Baseline (within 2 hours prior to start of study treatment administration), 0.5, 1, 2, 3, 4, 5 and 6 hours of IV infusion | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1- 0.17 mg/kg/hr APD418 | Participants were administered a single dose of 0.17 milligrams per kilogram per hour (mg/kg/hr) (total dose of 1 mg/kg) APD418 as an intravenous (IV) infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG001 | Cohort 1- Placebo | Participants were administered a single dose of matching placebo as an IV infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. |
|
| Secondary | Part A: Change in Systemic Vascular Resistance Index (SVRI) Measured by RHC at 0.5, 1, 2, 3, 4, 5 and 6 Hours | SVRI was calculated by dividing the difference between mean arterial pressure and central venous pressure by cardiac index and multiplying by 80. Change in SVRI measured by RHC at 0.5, 1, 2, 3, 4, 5 and 6 hours during the 6 hour IV infusion was reported in this outcome measure. | Full analysis set included all randomized participants, irrespective of whether they received any study treatment. All participants reported under 'Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' (n) signifies number of participants evaluable for specified timepoints. | Posted | | Mean | Standard Deviation | Dynes*second*meter^2 per centimeter^5 | | Baseline (within 2 hours prior to start of study treatment administration), 0.5, 1, 2, 3, 4, 5 and 6 hours of IV infusion | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1- 0.17 mg/kg/hr APD418 | Participants were administered a single dose of 0.17 milligrams per kilogram per hour (mg/kg/hr) (total dose of 1 mg/kg) APD418 as an intravenous (IV) infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG001 | Cohort 1- Placebo | Participants were administered a single dose of matching placebo as an IV infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. |
|
| Secondary | Part A: Change in Pulmonary Vascular Resistance (PVR) Measured by RHC at 0.5, 1, 2, 3, 4, 5 and 6 Hours | PVR is the resistance against blood flow from the pulmonary artery to the left atrium. Change in PVR measured by RHC at 0.5, 1, 2, 3, 4, 5 and 6 hours during the 6 hour IV infusion was reported in this outcome measure. | Full analysis set included all randomized participants, irrespective of whether they received any study treatment. All participants reported under 'Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' (n) signifies number of participants evaluable for specified timepoints. | Posted | | Mean | Standard Deviation | dynes*second per centimeter^5 | | Baseline (within 2 hours prior to start of study treatment administration), 0.5, 1, 2, 3, 4, 5 and 6 hours of IV infusion | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1- 0.17 mg/kg/hr APD418 | Participants were administered a single dose of 0.17 milligrams per kilogram per hour (mg/kg/hr) (total dose of 1 mg/kg) APD418 as an intravenous (IV) infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG001 | Cohort 1- Placebo | Participants were administered a single dose of matching placebo as an IV infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. |
|
| Secondary | Part A: Change in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Arterial Pressure (MAP) at 0.5, 1, 2, 3, 4, 5 and 6 Hours | SBP, DBP and MAP were measured in a supine or seated position after participant had at least 5 minutes of rest. MAP is the average pressure of the blood circulating through a participant's arteries during the cardiac cycle. MAP was derived by using the following formula: DBP + 1/3(SBP-DBP). | Full analysis set included all randomized participants, irrespective of whether they received any study treatment. | Posted | | Mean | Standard Deviation | Millimeters of mercury | | Baseline (within 2 hours prior to start of study treatment administration), 0.5, 1, 2, 3, 4, 5 and 6 hours of IV infusion | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1- 0.17 mg/kg/hr APD418 | Participants were administered a single dose of 0.17 milligrams per kilogram per hour (mg/kg/hr) (total dose of 1 mg/kg) APD418 as an intravenous (IV) infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG001 | Cohort 1- Placebo | Participants were administered a single dose of matching placebo as an IV infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG002 | Cohort 2- 0.5 mg/kg/hr APD418 |
|
| Secondary | Part A: Change in Heart Rate at 0.5, 1, 2, 3, 4, 5 and 6 Hours | Heart rate was measured in a supine or seated position after participant had at least 5 minutes of rest. | Full analysis set included all randomized participants, irrespective of whether they received any study treatment. | Posted | | Mean | Standard Deviation | Beats per minute | | Baseline (within 2 hours prior to start of study treatment administration), 0.5, 1, 2, 3, 4, 5 and 6 hours of IV infusion | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1- 0.17 mg/kg/hr APD418 | Participants were administered a single dose of 0.17 milligrams per kilogram per hour (mg/kg/hr) (total dose of 1 mg/kg) APD418 as an intravenous (IV) infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG001 | Cohort 1- Placebo | Participants were administered a single dose of matching placebo as an IV infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG002 | Cohort 2- 0.5 mg/kg/hr APD418 | Participants were administered a single dose of 0.5 mg/kg/hr (total dose of 3 mg/kg) APD418 as an IV infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. |
|
| Secondary | Part A: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An AE was any untoward medical occurrence that did not necessarily have a causal relationship with study treatment. TEAEs were defined as those AEs with onset after start date/timepoint of study drug administration. | Safety set included all randomized participants who received at least one dose of study treatment. | Posted | | Count of Participants | | Participants | | From start of study treatment on Day 1 up to Day 9 | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1- 0.17 mg/kg/hr APD418 | Participants were administered a single dose of 0.17 milligrams per kilogram per hour (mg/kg/hr) (total dose of 1 mg/kg) APD418 as an intravenous (IV) infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG001 | Cohort 1- Placebo | Participants were administered a single dose of matching placebo as an IV infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG002 | Cohort 2- 0.5 mg/kg/hr APD418 | Participants were administered a single dose of 0.5 mg/kg/hr (total dose of 3 mg/kg) APD418 as an IV infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. |
|
| Secondary | Part A: Area Under the Plasma Concentration Time Curve From Time Zero to 6 Hours (AUC[0-6]) of APD418 | AUC [0-6] was reported in this outcome measure. | Pharmacokinetic (PK) set included all participants in the safety set with at least 1 post-dose PK measurement. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*nanogram per milliliter | | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6 hours post infusion start | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1- 0.17 mg/kg/hr APD418 | Participants were administered a single dose of 0.17 milligrams per kilogram per hour (mg/kg/hr) (total dose of 1 mg/kg) APD418 as an intravenous (IV) infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG001 | Cohort 2- 0.5 mg/kg/hr APD418 | Participants were administered a single dose of 0.5 mg/kg/hr (total dose of 3 mg/kg) APD418 as an IV infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. |
| |
| Secondary | Part A: Area Under the Plasma Concentration Time Curve From Time Zero to Last Quantifiable Plasma Concentration (AUCLast) of APD418 | AUClast was reported in this outcome measure. | PK set included all participants in the safety set with at least 1 post-dose PK measurement. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*nanogram per milliliter | | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 6.083, 6.167, 6.25, 6.5, 7, 8, 10, 18 and 24 hours post infusion start | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1- 0.17 mg/kg/hr APD418 | Participants were administered a single dose of 0.17 milligrams per kilogram per hour (mg/kg/hr) (total dose of 1 mg/kg) APD418 as an intravenous (IV) infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG001 | Cohort 2- 0.5 mg/kg/hr APD418 | Participants were administered a single dose of 0.5 mg/kg/hr (total dose of 3 mg/kg) APD418 as an IV infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. |
| |
| Secondary | Part A: Area Under the Plasma Concentration Time Curve From Time Zero up to Infinity (AUC[0-Infinity]) of APD418 | AUC [0-infinity] was reported in this outcome measure. | PK set included all participants in the safety set with at least 1 post-dose PK measurement. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*nanogram per milliliter | | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 6.083, 6.167, 6.25, 6.5, 7, 8, 10, 18 and 24 hours post infusion start | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1- 0.17 mg/kg/hr APD418 | Participants were administered a single dose of 0.17 milligrams per kilogram per hour (mg/kg/hr) (total dose of 1 mg/kg) APD418 as an intravenous (IV) infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG001 | Cohort 2- 0.5 mg/kg/hr APD418 | Participants were administered a single dose of 0.5 mg/kg/hr (total dose of 3 mg/kg) APD418 as an IV infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. |
| |
| Secondary | Part A: Maximum Observed Plasma Concentration (Cmax) of APD418 | Cmax of APD418 was reported in this outcome measure. | PK set included all participants in the safety set with at least 1 post-dose PK measurement. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 6.083, 6.167, 6.25, 6.5, 7, 8, 10, 18 and 24 hours post infusion start | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1- 0.17 mg/kg/hr APD418 | Participants were administered a single dose of 0.17 milligrams per kilogram per hour (mg/kg/hr) (total dose of 1 mg/kg) APD418 as an intravenous (IV) infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG001 | Cohort 2- 0.5 mg/kg/hr APD418 | Participants were administered a single dose of 0.5 mg/kg/hr (total dose of 3 mg/kg) APD418 as an IV infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. |
| |
| Secondary | Part A: Terminal Elimination Half-Life (t1/2) for APD418 | Terminal t1/2 of APD418 was reported in this outcome measure. | PK set included all participants in the safety set with at least 1 post-dose PK measurement. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Hours | | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 6.083, 6.167, 6.25, 6.5, 7, 8, 10, 18 and 24 hours post infusion start | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1- 0.17 mg/kg/hr APD418 | Participants were administered a single dose of 0.17 milligrams per kilogram per hour (mg/kg/hr) (total dose of 1 mg/kg) APD418 as an intravenous (IV) infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG001 | Cohort 2- 0.5 mg/kg/hr APD418 | Participants were administered a single dose of 0.5 mg/kg/hr (total dose of 3 mg/kg) APD418 as an IV infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. |
| |
| Secondary | Part A: Distributional Half-Life (t1/2a) for APD418 | Distributional t1/2 of APD418 was reported in this outcome measure. | PK set included all participants in the safety set with at least 1 post-dose PK measurement. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Hours | | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 6.083, 6.167, 6.25, 6.5, 7, 8, 10, 18 and 24 hours post infusion start | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1- 0.17 mg/kg/hr APD418 | Participants were administered a single dose of 0.17 milligrams per kilogram per hour (mg/kg/hr) (total dose of 1 mg/kg) APD418 as an intravenous (IV) infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG001 | Cohort 2- 0.5 mg/kg/hr APD418 | Participants were administered a single dose of 0.5 mg/kg/hr (total dose of 3 mg/kg) APD418 as an IV infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. |
| |
| Secondary | Part A: Time to Maximum Observed Plasma Concentration (Tmax) for APD418 | Tmax of APD418 was reported in this outcome measure. | PK set included all participants in the safety set with at least 1 post-dose PK measurement. | Posted | | Median | Full Range | Hours | | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 6.083, 6.167, 6.25, 6.5, 7, 8, 10, 18 and 24 hours post infusion start | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1- 0.17 mg/kg/hr APD418 | Participants were administered a single dose of 0.17 milligrams per kilogram per hour (mg/kg/hr) (total dose of 1 mg/kg) APD418 as an intravenous (IV) infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG001 | Cohort 2- 0.5 mg/kg/hr APD418 | Participants were administered a single dose of 0.5 mg/kg/hr (total dose of 3 mg/kg) APD418 as an IV infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. |
| |
| Secondary | Part A: Total Clearance (CL) for APD418 | IV CL of APD418 was reported in this outcome measure. | The PK set included all participants in the safety set with at least 1 post-dose PK measurement. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liter per hour | | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 6.083, 6.167, 6.25, 6.5, 7, 8, 10, 18 and 24 hours post infusion start | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1- 0.17 mg/kg/hr APD418 | Participants were administered a single dose of 0.17 milligrams per kilogram per hour (mg/kg/hr) (total dose of 1 mg/kg) APD418 as an intravenous (IV) infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG001 | Cohort 2- 0.5 mg/kg/hr APD418 | Participants were administered a single dose of 0.5 mg/kg/hr (total dose of 3 mg/kg) APD418 as an IV infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. |
| |
| Secondary | Part A: Total Volume of Distribution Based on the Terminal Phase (Vdz) for APD418 | Vdz of APD418 was reported in this outcome measure. | PK set included all participants in the safety set with at least 1 post-dose PK measurement. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liter | | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 6.083, 6.167, 6.25, 6.5, 7, 8, 10, 18 and 24 hours post infusion start | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1- 0.17 mg/kg/hr APD418 | Participants were administered a single dose of 0.17 milligrams per kilogram per hour (mg/kg/hr) (total dose of 1 mg/kg) APD418 as an intravenous (IV) infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG001 | Cohort 2- 0.5 mg/kg/hr APD418 | Participants were administered a single dose of 0.5 mg/kg/hr (total dose of 3 mg/kg) APD418 as an IV infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. |
| |
| Secondary | Part A: Volume of Distribution at Steady State (Vdss) for APD418 | Vdss of APD418 was reported in this outcome measure. | PK set included all participants in the safety set with at least 1 post-dose PK measurement. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liter | | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 6.083, 6.167, 6.25, 6.5, 7, 8, 10, 18 and 24 hours post infusion start | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1- 0.17 mg/kg/hr APD418 | Participants were administered a single dose of 0.17 milligrams per kilogram per hour (mg/kg/hr) (total dose of 1 mg/kg) APD418 as an intravenous (IV) infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG001 | Cohort 2- 0.5 mg/kg/hr APD418 | Participants were administered a single dose of 0.5 mg/kg/hr (total dose of 3 mg/kg) APD418 as an IV infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. |
| |
| Secondary | Part A: Mean Residence Time From Time Zero to Time of Last Quantifiable Plasma Concentration (MRTlast) for APD418 | MRTlast of APD418 was reported in this outcome measure. | PK set included all participants in the safety set with at least 1 post-dose PK measurement. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours | | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 6.083, 6.167, 6.25, 6.5, 7, 8, 10, 18 and 24 hours post infusion start | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1- 0.17 mg/kg/hr APD418 | Participants were administered a single dose of 0.17 milligrams per kilogram per hour (mg/kg/hr) (total dose of 1 mg/kg) APD418 as an intravenous (IV) infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG001 | Cohort 2- 0.5 mg/kg/hr APD418 | Participants were administered a single dose of 0.5 mg/kg/hr (total dose of 3 mg/kg) APD418 as an IV infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. |
| |
| Secondary | Part A: Average Plasma Concentration During Dosing Interval (Cave) for ADP418 | Average plasma concentration calculated over the 6-hour infusion time was reported in this outcome measure. | PK set included all participants in the safety set with at least 1 post-dose PK measurement. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | | Pre-dose, 0.5, 1, 2, 3, 4, 5, 6 hours post infusion start | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1- 0.17 mg/kg/hr APD418 | Participants were administered a single dose of 0.17 milligrams per kilogram per hour (mg/kg/hr) (total dose of 1 mg/kg) APD418 as an intravenous (IV) infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG001 | Cohort 2- 0.5 mg/kg/hr APD418 | Participants were administered a single dose of 0.5 mg/kg/hr (total dose of 3 mg/kg) APD418 as an IV infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. |
| |
| Secondary | Part A: Renal Clearance (CLr) for ADP418 | CLr for APD418 was reported in this outcome measure. | PK set included all participants in the safety set with at least 1 post-dose PK measurement. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liter per hour | | Pre-dose (0) to 24 hours post infusion start, collected over 0 to 6 hour, 6 to 10 hour and 10 to 24-hour intervals | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1- 0.17 mg/kg/hr APD418 | Participants were administered a single dose of 0.17 milligrams per kilogram per hour (mg/kg/hr) (total dose of 1 mg/kg) APD418 as an intravenous (IV) infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG001 | Cohort 2- 0.5 mg/kg/hr APD418 | Participants were administered a single dose of 0.5 mg/kg/hr (total dose of 3 mg/kg) APD418 as an IV infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. |
| |
| Other Pre-specified | Part A: Amount of Unchanged Drug Excreted in Urine During Each Collection Interval From t1 to t2 (Aet1-t2) | Amount of unchanged drug excreted in urine during each collection interval from t1 to t2 was reported in this outcome measure. | PK set included all participants in the safety set with at least 1 post-dose PK measurement. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Milligrams | | Anytime between 0 to 6 hours, 6 to 10 hours and 10 to 24 hours post infusion start | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1- 0.17 mg/kg/hr APD418 | Participants were administered a single dose of 0.17 milligrams per kilogram per hour (mg/kg/hr) (total dose of 1 mg/kg) APD418 as an intravenous (IV) infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG001 | Cohort 2- 0.5 mg/kg/hr APD418 | Participants were administered a single dose of 0.5 mg/kg/hr (total dose of 3 mg/kg) APD418 as an IV infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. |
| |
| Other Pre-specified | Part A: Total Amount of Unchanged Drug Excreted in Urine Over the Collection Period (Amount Excreted [Ae]) | Total amount of unchanged drug excreted in urine over the collection period was reported in this outcome measure. | PK set included all participants in the safety set with at least 1 post-dose PK measurement. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Milligrams | | Pre-dose (0) to 24 hours post infusion start, collected over 0 to 6 hour, 6 to 10 hour and 10 to 24-hour intervals | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1- 0.17 mg/kg/hr APD418 | Participants were administered a single dose of 0.17 milligrams per kilogram per hour (mg/kg/hr) (total dose of 1 mg/kg) APD418 as an intravenous (IV) infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG001 | Cohort 2- 0.5 mg/kg/hr APD418 | Participants were administered a single dose of 0.5 mg/kg/hr (total dose of 3 mg/kg) APD418 as an IV infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. |
| |
| Other Pre-specified | Part A: Fraction of Drug Excreted Unchanged (Fe) in Urine | Fraction of drug excreted in urine was reported in this outcome measure. Data is presented in terms of percentages. | PK set included all participants in the safety set with at least 1 post-dose PK measurement. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Percentage of unchanged drug | | Pre-dose (0) to 24 hours post infusion start, collected over 0 to 6 hour, 6 to 10 hour and 10 to 24-hour intervals | | | | ID | Title | Description |
|---|
| OG000 | Cohort 1- 0.17 mg/kg/hr APD418 | Participants were administered a single dose of 0.17 milligrams per kilogram per hour (mg/kg/hr) (total dose of 1 mg/kg) APD418 as an intravenous (IV) infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. | | OG001 | Cohort 2- 0.5 mg/kg/hr APD418 | Participants were administered a single dose of 0.5 mg/kg/hr (total dose of 3 mg/kg) APD418 as an IV infusion over a duration of 6 hours on Day 1 (Dosing Period) followed by an 18 to 24-hour in-clinic observation period. |
| |