| Primary | Percentage of Participants With Disease Progression Using National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale at Day 14 | Disease progression was defined as the percentage of participants who were not alive or who had respiratory failure. Respiratory failure was defined as participants who had a score of 2, 3 or 4 on the NIAID 8-point ordinal scale: The NIAID scale is an assessment of clinical status on a given study day and was defined as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. The total score range was 1 to 8 where, higher score indicates improvement in the clinical status. | The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | percentage of participants | | At Day 14 | | | | ID | Title | Description |
|---|
| OG000 | MP1032 300mg + SoC | Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days. | | OG001 | Placebo + SoC | Participants received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0009.8(4.307 to 18.321)
- OG00111.6(3.885 to 25.083)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Mantel Haenszel | | 0.962 | | Common risk difference | -0.276 | | | 2-Sided | 95 | -11.634 | 11.081 | | | Strata-adjusted Mantel Haenszel (MH) method for difference in proportions controlling for stratification factors (COVID-19 severity: moderate, severe, and age group: less than or equal to 65 years, greater than 65 years). | | Superiority | | |
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| Secondary | Percentage of Participants With Disease Progression Using NIAID 8-point Ordinal Scale at Day 28 | Disease progression was defined as the percentage of participants who were not alive or who had respiratory failure. Respiratory failure was defined as participants who had a score of 2, 3 or 4 on the NIAID 8-point ordinal scale: The NIAID scale is an assessment of clinical status on a given study day and was defined as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or ECMO; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. The total score range was 1 to 8 where, higher score indicates improvement in the clinical status. | The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | percentage of participants | | At Day 28 | | | | ID | Title | Description |
|---|
| OG000 | MP1032 300mg + SoC | Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days. | |
|
| Secondary | Percentage of Participants With Disease Resolution at Day 28 | Disease resolution was defined as participants who were alive and had a score of 6, 7, or 8 on the NIAID 8-point ordinal scale. The NIAID scale is an assessment of clinical status on a given study day and was defined as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or ECMO; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. The total score range was 1 to 8 where, higher score indicates improvement in the clinical status. | The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | percentage of participants | | At Day 28 | | | | ID | Title | Description |
|---|
| OG000 | MP1032 300mg + SoC | Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days. | | OG001 | Placebo + SoC |
|
| Secondary | All-cause Mortality Rate up to Day 28 | All-cause mortality rate was the percentage of participants in each treatment group who died by Day 28 were reported. | The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Up to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | MP1032 300mg + SoC | Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days. | | OG001 | Placebo + SoC | Participants received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days. |
| |
| Secondary | Change From Baseline in Clinical Status Score Related to COVID-19 According to the NIAID 8-point Ordinal Scale at Day 28 | The NIAID 8-point Ordinal Scale is an assessment of the clinical status on a given study day and the scale was defined as follows: 1=Death, 2=Hospitalized, on invasive ventilation (mechanical ventilator and/or ECMO), 3=Hospitalized, on non-invasive ventilation or high-flow oxygen devices, 4=Hospitalized, requiring supplemental oxygen, 5=Hospitalized, not requiring supplemental oxygen, but requiring ongoing medical care (COVID-19 related or otherwise), 6=Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care (used if hospitalization was extended for infection-control reasons), 7=Not hospitalized, limitation on activities, and/or requiring home oxygen, 8=Not hospitalized, no limitations on activities. The total score range was 1 to 8 where, higher score indicates improvement in the clinical status. | The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline, Day 28 | | | | ID | Title | Description |
|---|
| OG000 | MP1032 300mg + SoC | Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days. | | OG001 | Placebo + SoC | Participants received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days. |
|
| Secondary | Percentage of Participants With Disease Resolution at Day 14 | Disease resolution was defined as participants who were alive and had a score of 6, 7, or 8 on the NIAID 8-point ordinal scale. The NIAID scale is an assessment of clinical status on a given study day and was defined as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or ECMO; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. The total score range was 1 to 8 where, higher score indicates improvement in the clinical status. | The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | percentage of participants | | At Day 14 | | | | ID | Title | Description |
|---|
| OG000 | MP1032 300mg + SoC | Participants received MP1032 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days. | | OG001 | Placebo + SoC |
|
| Secondary | All-cause Mortality Rate up to Day 14 and Day 60 | The percentage of participants who died by Day 14 and Day 60 were reported. | The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified timepoint. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Up to Day 14 and Day 60 | | | | ID | Title | Description |
|---|
| OG000 | MP1032 300mg + SoC | Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days. | | OG001 | Placebo + SoC | Participants received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days. |
| |
| Secondary | Change From Baseline in Clinical Status Score Related to COVID-19 According to the NIAID 8-point Ordinal Scale at Day 14 | The NIAID scale is an assessment of clinical status on a given study day and was defined as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or ECMO; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. The total score range was 1 to 8 where, higher score indicates improvement in the clinical status. The change from baseline in NIAID clinical status score related to COVID-19 at Day 14 were reported. | The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline, Day 14 | | | | ID | Title | Description |
|---|
| OG000 | MP1032 300mg + SoC | Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days. | | OG001 | Placebo + SoC |
|
| Secondary | Percentage of Participants Who Required Invasive Ventilation (Mechanical Ventilator and/ ECMO), or Who Died at Day 14 and Day 28 | Percentage of participants who required invasive mechanical ventilation/ECMO or who died by Day 14 and Day 28 were reported. | The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified timepoints. | Posted | | Number | 95% Confidence Interval | percentage of participants | | At Day 14 and Day 28 | | | | ID | Title | Description |
|---|
| OG000 | MP1032 300mg + SoC | Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days. | | OG001 | Placebo + SoC | Participants received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days. |
| |
| Secondary | Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit | The NIAID scale is an assessment of clinical status on a given study day and was defined as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or ECMO; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. The total score range was 1 to 8 where, higher score indicates improvement in the clinical status. The change from baseline in NIAID clinical status score at each visit were reported. | The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified timepoints. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline up to Day 60 | | | | ID | Title | Description |
|---|
| OG000 | MP1032 300mg + SoC | Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days. | | OG001 |
|
| Secondary | Time to (First) Improvement of at Least 1 Category on the NIAID 8-point Ordinal Scale | The NIAID scale is an assessment of clinical status on a given study day and was defined as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or ECMO; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. Participants who did not improve at least 1 category on the NIAID scale or died before Day 28 were censored at Day 28. The total score range was 1 to 8 where, higher score indicates improvement in the clinical status. | The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. As the table refers to "time to improvement', here, "Overall Number of Participants Analyzed" only signifies participants with at least 1 NIAID category of improvement at any time up to Day 28. | Posted | | Median | 95% Confidence Interval | days | | Baseline up to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | MP1032 300mg + SoC | Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days. | | OG001 |
|
| Secondary | Percentage of Participants With Clinical Status Improvement of at Least 1 Category From Baseline on the NIAID 8-point Ordinal Scale at Day 14 and Day 28 | NIAID scale is an assessment of clinical status on a given study day and was defined as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or ECMO; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. Higher score = improvement in clinical status. Percentage of Participants with Clinical Status Improvement of at least 1 category from baseline on the NIAID 8-point Ordinal Scale at Day 14 and Day 28 were reported. | The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. Here, "Number Analyzed" signifies participants for whom NIAID data were available for Day 14 and Day 28, respectively. | Posted | | Number | | percentage of participants | | Baseline, Day 14 and Day 28 | | | | ID | Title | Description |
|---|
| OG000 | MP1032 300mg + SoC | Participants received MP1032 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days. | | OG001 |
|
| Secondary | Time to Discharge by Day 28 and Day 60 | Time to discharge i.e., the total duration of participant hospitalization from baseline to discharge at Day 28 and Day 60 was reported. | The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified timepoints. | Posted | | Median | 95% Confidence Interval | days | | Baseline, Day 28 and Day 60 | | | | ID | Title | Description |
|---|
| OG000 | MP1032 300mg + SoC | Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days. | | OG001 | Placebo + SoC | Participants received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days. |
| |
| Secondary | Percentage of Participants Who Were Alive and Tested Negative for COVID-19 at Day 14, Day 28, and Day 60 | Percentage of participants who were alive and tested negative for COVID-19 at Day 14, Day 28, and Day 60 were reported. | The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified timepoints. | Posted | | Number | 95% Confidence Interval | percentage of participants | | At Day 14, Day 28 and Day 60 | | | | ID | Title | Description |
|---|
| OG000 | MP1032 300mg + SoC | Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days. | | OG001 | Placebo + SoC | Participants received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days. |
| |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | An Adverse Event (AE) was any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at screening, worsens during the study, regardless of the suspected cause of the event. TEAE was defined as any adverse event which starts or worsens at any time after initiation of study drug until the end of the follow-up period at Day 60. An SAE was any untoward medical occurrence that at any dose met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. Number of participants with TEAEs and Serious TEAEs were reported. | The Safety Set included all randomized participants who received at least 1 dose of study drug. | Posted | | Count of Participants | | Participants | | Day 1 up to Day 60 | | | | ID | Title | Description |
|---|
| OG000 | MP1032 300mg + SoC | Participants received MP1032 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days. | | OG001 | Placebo + SoC | Participants received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days. |
| |
| Secondary | Number of Participants With Clinically Significant Change in Vital Sign | Vital sign parameters included of systolic and diastolic blood pressure, heart rate, respiration rate, oxygen saturation (SpO2), and body temperature. Any clinically significant change in vital signs were judged by the investigator. Number of participants with clinically significant change in vital sign values were reported. | The Safety Set included all randomized participants who received at least 1 dose of study drug. | Posted | | Count of Participants | | Participants | | Day 1 up to Day 60 | | | | ID | Title | Description |
|---|
| OG000 | MP1032 300mg + SoC | Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days. | | OG001 | Placebo + SoC | Participants received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days. |
| |
| Secondary | Number of Participants With Clinically Significant Abnormalities in Physical Examinations | Physical examination included examination of respiratory, cardiovascular, dermatological, neurological, and gastrointestinal system. Any clinically significant abnormalities in physical examination were judged by the investigator. Number of participants with clinically significant abnormalities in physical examinations findings were reported. | The Safety Set included all randomized participants who received at least 1 dose of study drug. Here, "Overall number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified timepoints. | Posted | | Count of Participants | | Participants | | Baseline up to Day 60 | | | | ID | Title | Description |
|---|
| OG000 | MP1032 300mg + SoC | Participants received MP1032 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days. | | OG001 | Placebo + SoC | Participants received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days. |
| |
| Secondary | Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Results | Clinical laboratory tests included biochemistry, hematology and urinalysis. Any clinically significant abnormalities in clinical laboratory results were judged by the investigator. Number of participants with clinically significant abnormalities in laboratory results were reported. | The Safety Set included all randomized participants who received at least 1 dose of study drug. | Posted | | Count of Participants | | Participants | | Baseline up to Day 60 | | | | ID | Title | Description |
|---|
| OG000 | MP1032 300mg + SoC | Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days. | | OG001 | Placebo + SoC | Participants received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days. |
| |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of MP1032 | Cmax of MP1032 in plasma were reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported. | The Pharmacokinetic (PK) Analysis Set included all the participants who were administered active study drug and had at least 1 post-dose evaluable plasma concentration after Day 1 dose. Here, "number analyzed" signifies participants who were evaluable at a specified timepoint. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanograms per millilitre (ng/mL) | | Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 and Day 7 | | | | ID | Title | Description |
|---|
| OG000 | MP1032 300mg + SoC | Participants received MP1032 300 mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days. |
| |
| Secondary | Area Under the Plasma Concentration-time Curve From Time Zero to Last Non-zero Concentration (AUC0-t) of MP1032 | AUC0-t of MP1032 in plasma were reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported. | The PK Analysis Set included all the participants who were administered active study drug and had at least 1 post-dose evaluable plasma concentration after Day 1 dose. Here, "number analyzed" signifies participants who were evaluable at a specified timepoints. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hour*nanograms per millilitre (h*ng/mL) | | Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 and Day 7 | | | | ID | Title | Description |
|---|
| OG000 | MP1032 300mg + SoC | Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days. |
| |
| Secondary | Apparent Elimination Rate Constant (Kel) of MP1032 | Kel was calculated using negative of the estimated slope of the linear regression of the ln-transformed plasma concentration versus time profile in the terminal elimination phase. Kel of MP1032 in plasma were reported. | The PK Analysis Set included all the participants who were administered active study drug and had at least 1 post-dose evaluable plasma concentration after Day 1 dose. | Posted | | Mean | Standard Deviation | Per hour (1/h) | | Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 | | | | ID | Title | Description |
|---|
| OG000 | MP1032 300mg + SoC | Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days. |
| |
| Secondary | Apparent Body Clearance (CL/F) of MP1032 | Cl/F was estimated as Dose/AUC0-inf. CL/F of MP1032 in plasma was reported. | The PK Analysis Set included all the participants who were administered active study drug and had at least 1 post-dose evaluable plasma concentration after Day 1 dose. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | liter per hour (l/h) | | Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 | | | | ID | Title | Description |
|---|
| OG000 | MP1032 300 mg + SoC | Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days. |
| |
| Secondary | Apparent Volume of Distribution (Vz/F) of MP1032 | Vz/F was estimated as Dose/(Kel x AUC0-inf). Vz/F of MP1032 in plasma was reported. | The PK Analysis Set included all the participants who were administered active study drug and had at least 1 post-dose evaluable plasma concentration after Day 1 dose. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | liter | | Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 | | | | ID | Title | Description |
|---|
| OG000 | MP1032 300mg + SoC | Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days. |
| |
| Secondary | Plasma Concentration Prior to the Next Dose (Ctrough) of MP1032 | Ctrough of MP1032 in plasma was reported. | The PK Analysis Set included all the participants who were administered active study drug and had at least 1 post-dose evaluable plasma concentration after Day 1 dose. Here, "number analyzed" signifies participants who were evaluable at specified timepoints. | Posted | | Mean | Standard Deviation | ng/ml | | Pre-dose concentration (Day 2, Day 7, and Day 8). | | | | ID | Title | Description |
|---|
| OG000 | MP1032 300mg + SoC | Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days. |
| |
| Secondary | Average Observed Plasma Concentration at Steady State of MP1032 | Average observed plasma concentration at steady state of MP1032 was reported. | The PK Analysis Set included all the participants who were administered active study drug and had at least 1 post-dose evaluable plasma concentration after Day 1 dose. Here, "number analyzed" signifies participants who were evaluable at a specified timepoints. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/ml | | Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 and Day 7 | | | | ID | Title | Description |
|---|
| OG000 | MP1032 300mg + SoC | Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days. |
| |