Essential Tremor
Conditions
Brief summary
Stage 1 is a double-blind, proof-of-concept study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of SAGE-547 Injection in male and female participants with essential tremor in the upper limb. Stage 2 is an open-label arm designed to evaluate the safety, tolerability, PK, and effectiveness of SAGE-547 Injection at a higher dose than in Stage 1. Participants who completed Stage 1 were invited to participate in Stage 2.
Interventions
DRUGSAGE-547
DRUGPlacebo
Sponsors
Sage Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Males and females, 35-75 years old with a diagnosis of essential tremor with symptoms clearly present in at least 1 upper limb; participant has had tremor present for at least 2 years prior to Screening * Off medication, or on a stable dose of medication for their tremor for at least 28 days prior to Screening
Exclusion criteria
* Recent history or active clinically significant manifestations of metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, musculoskeletal, dermatological, urogenital, eyes, ears, nose, or throat, psychiatric, or neurological (other than essential tremor) disorders * Medical history of seizures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stage 2: Change From Baseline in ECG Parameter - Heart Rate | Stage 2 Day 1: Pre-infusion (Baseline) and 10 hours post-infusion | ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in heart rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Absolute Values of Hematology Parameter - Lymphocyte Levels | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for lymphocyte levels are reported in this outcome measure. |
| Stage 1: Change From Baseline in Hematology Parameter - Leukocyte Levels | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in leukocyte levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Absolute Values of Hematology Parameter - Leukocyte Levels | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for leukocyte levels are reported in this outcome measure. |
| Stage 1: Change From Baseline in Hematology Parameter - Erythrocytes Mean Corpuscular Volume Levels | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in erythrocytes mean corpuscular volume levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Absolute Values of Hematology Parameter - Erythrocytes Mean Corpuscular Volume Levels | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for erythrocytes mean corpuscular volume levels are reported in this outcome measure. |
| Stage 1: Change From Baseline in Hematology Parameter - Mean Cell Hemoglobin Levels | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in mean cell hemoglobin levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Absolute Values of Hematology Parameter - Mean Cell Hemoglobin | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for mean cell hemoglobin levels are reported in this outcome measure. |
| Stage 1: Change From Baseline in Electrocardiogram (ECG) Parameter - QT Interval | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8,12 hours during infusion | ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QT interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Change From Baseline in ECG Parameter - QT Interval | Stage 2 Day 1: Pre-infusion (Baseline) and 10 hours post-infusion | ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QT interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 1: Change From Baseline in ECG Parameter - PR Interval | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8,12 hours during infusion | ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in PR interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Change From Baseline in ECG Parameter - PR Interval | Stage 2 Day 1: Pre-infusion (Baseline) and 10 hours post-infusion | ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in PR interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 1: Change From Baseline in ECG Parameter - QRS Duration | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion | ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QRS duration is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Change From Baseline in ECG Parameter - QRS Duration | Stage 2 Day 1: Pre-infusion (Baseline) and 10 hours post-infusion | ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QRS duration is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 1: Change From Baseline in ECG Parameter - QTcB Interval | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion | ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QTcB interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Change From Baseline in ECG Parameter - QTcB Interval | Stage 2 Day 1: Pre-infusion (Baseline) and 10 hours post-infusion | ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QTcB interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 1: Change From Baseline in ECG Parameter - QTcF Interval | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion | ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QTcF interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Change From Baseline in ECG Parameter - QTcF Interval | Stage 2 Day 1: Pre-infusion (Baseline) and 10 hours post-infusion | ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QTcF interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 1: Change From Baseline in ECG Parameter - Heart Rate | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion | ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in heart rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Stage 1: Up to 30 days after last infusion (up to Day 40) | An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was defined as an AE with start date/time after the start of initial infusion in each stage. An SAE is defined as an AE or suspected adverse reaction, which in the view of either the Investigator or Sponsor, results in any of the following outcomes: death; is life-threatening; inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant disability or incapacity; congenital anomaly or birth defect or other medically important condition. |
| Stage 2: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Stage 2: Up to 30 days after last infusion (up to Day 31) | An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was defined as an AE with start date/time after the start of initial infusion in each stage. An SAE is defined as an AE or suspected adverse reaction, which in the view of either the Investigator or Sponsor, results in any of the following outcomes: death; is life-threatening; inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant disability or incapacity; congenital anomaly or birth defect or other medically important condition. |
| Stage 1: Percentage of Participants With a Response of 'Yes' to Any Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation or Suicidal Behavior Item at Any Visit | Stage 1: Pre-infusion on Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2) | The C-SSRS scale consisted of baseline evaluation that assessed lifetime experience of participants with suicidal ideation (SI) and suicidal behavior (SB) and postbaseline evaluation that focused on suicidality since last study visit. C-SSRS included yes or no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present \[from 1 (minor physical damage) to 5 (death), with 5 being most severe\]. C-SSRS SI items involved (a) wish to be dead, (b) non-specific active suicidal thoughts, (c) active SI with any methods (not plan) without intent to act, (d) active SI with some intent to act, without specific plan and (e) active SI with specific plan and intent. C-SSRS SB items involved (a) actual attempt, (b) engaged in non-suicidal self-injurious behavior, (c) interrupted attempt, (d) aborted attempt, (e) preparatory acts or behavior, (f) suicidal behavior. Only categories with data are reported. |
| Stage 2: Percentage of Participants With a Response of 'Yes' to Any Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation or Suicidal Behavior Item at Any Visit | Stage 2 Day 1: Pre-infusion and 10 hours and 7-day follow-up post-infusion | The C-SSRS scale consisted of baseline evaluation that assessed lifetime experience of participants with SI and SB and postbaseline evaluation that focused on suicidality since last study visit. C-SSRS included yes or no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present \[from 1 (minor physical damage) to 5 (death), with 5 being most severe\]. C-SSRS SI items involved (a) wish to be dead, (b) non-specific active suicidal thoughts, (c) active SI with any methods (not plan) without intent to act, (d) active SI with some intent to act, without specific plan and (e) active SI with specific plan and intent. C-SSRS SB items involved (a) actual attempt, (b) engaged in non-suicidal self-injurious behavior, (c) interrupted attempt, (d) aborted attempt, (e) preparatory acts or behavior, (f) suicidal behavior. |
| Stage 1: Change From Baseline (CFB) in Vital Signs Parameter - Supine Systolic Blood Pressure | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in supine systolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Change From Baseline in Vital Signs Parameter - Supine Systolic Blood Pressure | Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in supine systolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 1: Change From Baseline in Vital Signs Parameter - Supine Diastolic Blood Pressure | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in supine diastolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Change From Baseline in Vital Signs Parameter - Supine Diastolic Blood Pressure | Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in supine diastolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 1: Change From Baseline in Vital Signs Parameter - Supine Heart Rate | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in supine heart rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Change From Baseline in Vital Signs Parameter - Supine Heart Rate | Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in supine heart rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 1: Change From Baseline in Vital Signs Parameter - Standing Systolic Blood Pressure | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in standing systolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Change From Baseline in Vital Signs Parameter - Standing Systolic Blood Pressure | Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in standing systolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 1: Change From Baseline in Vital Signs Parameter - Standing Diastolic Blood Pressure | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in standing diastolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Change From Baseline in Vital Signs Parameter - Standing Diastolic Blood Pressure | Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in standing diastolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 1: Change From Baseline in Vital Signs Parameter - Standing Heart Rate | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in standing heart rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Change From Baseline in Vital Signs Parameter - Standing Heart Rate | Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in standing heart rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 1: Change From Baseline in Vital Signs Parameter - Temperature | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in temperature is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Change From Baseline in Vital Signs Parameter - Temperature | Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in temperature is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 1: Change From Baseline in Vital Signs Parameter - Respiratory Rate | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in respiratory rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Change From Baseline in Vital Signs Parameter - Respiratory Rate | Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion | Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in respiratory rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 1: Change From Baseline in Serum Chemistry Parameter - Alanine Aminotransferase Levels | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in alanine aminotransferase levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Absolute Values of Serum Chemistry Parameter - Alanine Aminotransferase Levels | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for alanine aminotransferase levels are reported in this outcome measure. |
| Stage 1: Change From Baseline in Serum Chemistry Parameter - Aspartate Aminotransferase Levels | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in aspartate aminotransferase levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Absolute Values of Serum Chemistry Parameter - Aspartate Aminotransferase Levels | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for aspartate aminotransferase levels are reported in this outcome measure. |
| Stage 1: Change From Baseline in Serum Chemistry Parameter - Gamma Glutamyl Transferase Levels | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in gamma glutamyl transferase levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Absolute Values of Serum Chemistry Parameter - Gamma Glutamyl Transferase Levels | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for gamma glutamyl transferase levels are reported in this outcome measure. |
| Stage 1: Change From Baseline in Serum Chemistry Parameter - Sodium Levels | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in sodium levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Absolute Values of Serum Chemistry Parameter - Sodium Levels | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for sodium levels are reported in this outcome measure. |
| Stage 1: Change From Baseline in Serum Chemistry Parameter - Potassium Levels | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in potassium levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Absolute Values of Serum Chemistry Parameter - Potassium Levels | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for potassium levels are reported in this outcome measure. |
| Stage 1: Change From Baseline in Serum Chemistry Parameter - Calcium Levels | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in calcium levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Absolute Values of Serum Chemistry Parameter - Calcium Levels | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for calcium levels are reported in this outcome measure. |
| Stage 1: Change From Baseline in Serum Chemistry Parameter - Chloride Levels | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in chloride levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Absolute Values of Serum Chemistry Parameter - Chloride Levels | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for chloride levels are reported in this outcome measure. |
| Stage 1: Change From Baseline in Serum Chemistry Parameter - Bicarbonate Levels | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in bicarbonate levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Absolute Values of Serum Chemistry Parameter - Bicarbonate Levels | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for bicarbonate levels are reported in this outcome measure. |
| Stage 1: Change From Baseline in Serum Chemistry Parameter - Protein Levels | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in protein levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Absolute Values of Serum Chemistry Parameter - Protein Levels | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for protein levels are reported in this outcome measure. |
| Stage 1: Change From Baseline in Serum Chemistry Parameter - Glucose Levels | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in glucose levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Absolute Values of Serum Chemistry Parameter - Glucose Levels | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for glucose levels are reported in this outcome measure. |
| Stage 1: Change From Baseline in Serum Chemistry Parameter - Lactate Dehydrogenase Levels | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in lactate dehydrogenase levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Absolute Values of Serum Chemistry Parameter - Lactate Dehydrogenase Levels | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for lactate dehydrogenase levels are reported in this outcome measure. |
| Stage 1: Change From Baseline in Serum Chemistry Parameter - Cholesterol Levels | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in cholesterol levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Absolute Values of Serum Chemistry Parameter - Cholesterol Level | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for cholesterol levels are reported in this outcome measure. |
| Stage 1: Change From Baseline in Serum Chemistry Parameter - Triglyceride Levels | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in triglyceride levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Absolute Values of Serum Chemistry Parameter - Triglyceride Levels | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for triglyceride levels are reported in this outcome measure. |
| Stage 1: Change From Baseline in Serum Chemistry Parameter - Albumin Levels | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in albumin levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Absolute Values of Serum Chemistry Parameter - Albumin Levels | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for albumin levels are reported in this outcome measure. |
| Stage 1: Change From Baseline in Serum Chemistry Parameter - Bilirubin Levels | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in bilirubin levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Absolute Values of Serum Chemistry Parameter - Bilirubin Levels | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for bilirubin levels are reported in this outcome measure. |
| Stage 1: Change From Baseline in Serum Chemistry Parameter - Creatinine Levels | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in creatinine levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Absolute Values of Serum Chemistry Parameter - Creatinine Levels | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for creatinine levels are reported in this outcome measure. |
| Stage 1: Change From Baseline in Serum Chemistry Parameter - Blood Urea Nitrogen Levels | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in blood urea nitrogen levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Absolute Values of Serum Chemistry Parameter - Blood Urea Nitrogen Levels | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for blood urea nitrogen levels are reported in this outcome measure. |
| Stage 1: Change From Baseline in Serum Chemistry Parameter - Alkaline Phosphatase Levels | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in alkaline phosphatase levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Absolute Values of Serum Chemistry Parameter - Alkaline Phosphatase Levels | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for alkaline phosphatase levels are reported in this outcome measure. |
| Stage 1: Change From Baseline in Serum Chemistry Parameter - Creatine Kinase Levels | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in creatinine kinase levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Absolute Values of Serum Chemistry Parameter - Creatine Kinase Levels | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for creatinine kinase levels are reported in this outcome measure. |
| Stage 1: Change From Baseline in Serum Chemistry Parameter - Phosphate Levels | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in phosphate levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Absolute Values of Serum Chemistry Parameter - Phosphate Levels | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for phosphate levels are reported in this outcome measure. |
| Stage 1: Change From Baseline in Serum Chemistry Parameter - Urate Levels | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in urate levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Absolute Values of Serum Chemistry Parameter - Urate Levels | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up | Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for urate levels are reported in this outcome measure. |
| Stage 1: Change From Baseline in Hematology Parameter - Hemoglobin Levels | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in hemoglobin levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Absolute Values of Hematology Parameter - Hemoglobin Levels | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for hemoglobin levels are reported in this outcome measure. |
| Stage 1: Change From Baseline in Hematology Parameter - Hematocrit Levels | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in hematocrit levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Absolute Values of Hematology Parameter - Hematocrit Levels | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for hematocrit levels are reported in this outcome measure. |
| Stage 1: Change From Baseline in Hematology Parameter - Platelet Levels | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in platelet levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Absolute Values of Hematology Parameter - Platelet Levels | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for platelet levels are reported in this outcome measure. |
| Stage 1: Change From Baseline in Hematology Parameter - Erythrocyte Levels | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in erythrocyte levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Absolute Values of Hematology Parameter - Erythrocyte Levels | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for erythrocyte levels are reported in this outcome measure. |
| Stage 1: Change From Baseline in Hematology Parameter - Neutrophil Levels | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in neutrophil levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Absolute Values of Hematology Parameter - Neutrophil Levels | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for neutrophil levels are reported in this outcome measure. |
| Stage 1: Change From Baseline in Hematology Parameter - Basophil Levels | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in basophil levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Absolute Values of Hematology Parameter - Basophil Levels | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for basophil levels are reported in this outcome measure. |
| Stage 1: Change From Baseline in Hematology Parameter - Eosinophil Levels | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in eosinophil levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Absolute Values of Hematology Parameter - Eosinophil Levels | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for eosinophil levels are reported in this outcome measure. |
| Stage 1: Change From Baseline in Hematology Parameter - Monocyte Levels | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in monocyte levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Absolute Values of Hematology Parameter - Monocyte Levels | Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for monocyte levels are reported in this outcome measure. |
| Stage 1: Change From Baseline in Hematology Parameter - Lymphocyte Levels | Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion | Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in lymphocyte levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stage 2: Change From Baseline in Accelerometer Total Score Response | Stage 2 Day 1: Baseline and 2, 3, 4, 6, 8, 10, 12, 14 and 24 hours | Accelerometer total score response was defined as ≥30% decrease from baseline to each time point in accelerometer total score. Accelerometer total score is sum of forward outstretched postural tremor, lateral wing beating postural tremor, and kinetic tremor scores across both sides of the body (i.e., right and left). Accelerometer was used for transducer measurement of tremor amplitude. Participants wore wireless ring motion sensor. It measured linear acceleration and angular velocity (i.e., kinesia score). Information from motion sensor data was correlated to symptoms of tremor. Kinesia (accelerometer) scores ranged from 0 to 4 in 0.5 step increments. The total score ranges from 0 to 24, higher scores indicating more severe tremors. Negative change from baseline indicated decrease in tremor. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 1: Change From Baseline in The Essential Tremor Rating Scale (TETRAS) Using Performance Subscale (PS) Part 4 Upper-Limb Total Scores | Stage 1 Days 1 and 10: Pre-infusion (Baseline) and 2, 4, 6, 8, 10 and 12 hours and 12-hour follow-up post-infusion | The TETRAS PS total score was calculated as the sum of items 4 (upper-limb), 6 (Archimedes spiral), 7 (handwriting), and 8 (dot approximation). TETRAS PS upper-limb total score was calculated as the sum of the 6 separate upper-limb maneuvers assessed by the clinician: forward-outstretched postural tremor \[right\], forward outstretched postural tremor \[left\], lateral wing-beating postural tremor \[right\], lateral wing-beating postural tremor \[left\], kinetic tremor \[right\], kinetic tremor \[left\], each on a 0 (no tremor) to 4 (maximum tremor) severity scale in 0.5-point increments. TETRAS Part 4 score for both upper limbs ranged from 0 to 24, higher scores indicated more severe tremor. A negative change from baseline indicated less tremor. Baseline is defined as the pre-infusion value in each period/stage. |
| Stage 2: Change From Baseline in TETRAS Using PS Part 4 Upper-Limb Total Scores | Stage 2 Day 1: Baseline and at 2, 3, 4, 6, 8, 10, 12, 14 and 24 hours | The TETRAS PS total score was calculated as the sum of items 4 (upper-limb), 6 (Archimedes spiral), 7 (handwriting), and 8 (dot approximation). TETRAS PS upper-limb total score was calculated as the sum of the 6 separate upper-limb maneuvers assessed by the clinician: forward-outstretched postural tremor \[right\], forward outstretched postural tremor \[left\], lateral wing-beating postural tremor \[right\], lateral wing-beating postural tremor \[left\], kinetic tremor \[right\], kinetic tremor \[left\], each on a 0 (no tremor) to 4 (maximum tremor) severity scale in 0.5-point increments. TETRAS Part 4 score for both upper limbs ranged from 0 to 24, higher scores indicated more severe tremor. A negative change from baseline indicated less tremor. |
| Stage 1: Change From Baseline in Stanford Sleepiness Scale (SSS) Score | Stage 1 Day 1 and 10: Pre-infusion (Baseline) and 2, 4, 6, 8, 10 and 12 hours and 12-hour follow-up post-infusion | SSS is a participant-rated scale designed to quickly assess how alert a participant was feeling. Degrees of sleepiness and alertness were rated on a scale of 1 to 7, where the lowest score of '1' indicated the participant was 'feeling active, vital, alert, or wide awake' and the highest score of '7' indicated the participant was 'no longer fighting sleep, sleep onset soon; having dream-like thoughts'. Baseline is defined as the pre-infusion value in each period. A negative change from baseline indicated less sleepiness. |
| Stage 2: Change From Baseline in Stanford Sleepiness Scale (SSS) Score | Stage 2 Day 1: Baseline and at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours | SSS is a participant-rated scale designed to quickly assess how alert a participant was feeling. Degrees of sleepiness and alertness were rated on a scale of 1 to 7, where the lowest score of '1' indicated the participant was 'feeling active, vital, alert, or wide awake' and the highest score of '7' indicated the participant was 'no longer fighting sleep, sleep onset soon; having dream-like thoughts'. Baseline is defined as the pre-infusion value in each period. A negative change from baseline indicated less sleepiness. |
| Stage 1: Maximum Peak Plasma Concentration (Cmax) of SAGE-547 | Stage 1: Pre-infusion and after the start of infusion at 30 and 40 minutes and at 1, 1.5, 2, 4, 6, 8, 10, 12, 12.5, 12.75, 13, 13.5, 14, 16 and 24 hours | — |
| Stage 2: Maximum Peak Plasma Concentration (Cmax) of SAGE-547 | Stage 2: Pre-infusion and at 30, 60, 90 and 120 minutes and at 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 10.5, 10.75, 11, 11.5, 12, 14, 16 and 24 hours after start of the infusion | — |
| Stage 1: Time to Maximum Peak Plasma Concentration (Cmax) of SAGE-547 | Stage 1: Pre-infusion and after the start of infusion at 30 and 40 minutes and at 1, 1.5, 2, 4, 6, 8, 10, 12, 12.5, 12.75, 13, 13.5, 14, 16 and 24 hours | — |
| Stage 2: Time to Maximum Peak Plasma Concentration (Cmax) of SAGE-547 | Stage 2: Pre-infusion and at 30, 60, 90 and 120 minutes and at 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 10.5, 10.75, 11, 11.5, 12, 14, 16 and 24 hours after start of the infusion | — |
| Stage 1: Area Under the Plasma Concentration Time Curve up to the Time of the Last Quantifiable Sample (AUClast) of SAGE-547 | Stage 1: Pre-infusion and after the start of infusion at 30 and 40 minutes and at 1, 1.5, 2, 4, 6, 8, 10, 12, 12.5, 12.75, 13, 13.5, 14, 16 and 24 hours | — |
| Stage 2: Area Under the Plasma Concentration Time Curve up to the Time of the Last Quantifiable Sample (AUClast) of SAGE-547 | Day 1: Pre-infusion and at 30, 60, 90 and 120 minutes and at 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 10.5, 10.75, 11, 11.5, 12, 14, 16 and 24 hours after start of the infusion | — |
| Stage 1: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of SAGE-547 | Stage 1: Pre-infusion and after the start of infusion at 30 and 40 minutes and at 1, 1.5, 2, 4, 6, 8, 10, 12, 12.5, 12.75, 13, 13.5, 14, 16 and 24 hours | — |
| Stage 2: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of SAGE-547 | Stage 2: Pre-infusion and at 30, 60, 90 and 120 minutes and at 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 10.5, 10.75, 11, 11.5, 12, 14, 16 and 24 hours after start of the infusion | — |
| Stage 1: Clearance (CL) of SAGE-547 | Stage 1: Pre-infusion and after the start of infusion at 30 and 40 minutes and at 1, 1.5, 2, 4, 6, 8, 10, 12, 12.5, 12.75, 13, 13.5, 14, 16 and 24 hours | Clearance is defined as the volume of plasma from which a substance is completely removed per unit time. |
| Stage 2: Clearance (CL) of SAGE-547 | Stage 2: Pre-infusion and at 30, 60, 90 and 120 minutes and at 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 10.5, 10.75, 11, 11.5, 12, 14, 16 and 24 hours after start of the infusion | Clearance is defined as the volume of plasma from which a substance is completely removed per unit time. |
| Stage 1: Terminal Half-Life (t½) of SAGE-547 | Stage 1: Pre-infusion and after the start of infusion at 30 and 40 minutes and at 1, 1.5, 2, 4, 6, 8, 10, 12, 12.5, 12.75, 13, 13.5, 14, 16 and 24 hours | Terminal half-life is defined as the time required to divide the plasma concentration by two after reaching pseudo-equilibrium. |
| Stage 2: Terminal Half-Life (t½) of SAGE-547 | Stage 2: Pre-infusion and at 30, 60, 90 and 120 minutes and at 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 10.5, 10.75, 11, 11.5, 12, 14, 16 and 24 hours after start of the infusion | Terminal half-life is defined as the time required to divide the plasma concentration by two after reaching pseudo-equilibrium. |
| Stage 1: Change From Baseline in Accelerometer Total Score Response | Stage 1 Days 1 and 10: Pre-infusion (Baseline) and 2, 4, 6, 8, 10 and 12 hours and 12-hour follow-up post-infusion | Accelerometer total score response was defined as ≥30% decrease from baseline to each time point in accelerometer total score. Accelerometer total score is sum of forward outstretched postural tremor, lateral wing-beating postural tremor, and kinetic tremor scores across both sides of the body (i.e., right and left). Accelerometer was used for transducer measurement of tremor amplitude. Participants wore wireless ring motion sensor. It measured linear acceleration and angular velocity (i.e., kinesia score). Information from motion sensor data was correlated to symptoms of tremor. Kinesia (accelerometer) scores ranged from 0 to 4 in 0.5 step increments. The total score ranges from 0 to 24, higher scores indicating more severe tremors. Negative change from baseline indicated decrease in tremor. Baseline is defined as the pre-infusion value in each period/stage. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled at 2 investigative sites in the United States from 23 September 2014 to 14 August 2015.
Pre-assignment details
This study consisted of two stages, Stages 1 and 2. Stage 1 had two periods with treatment on Days 1 and 10 and a 7-day follow-up period. Participants were followed for serious adverse events (SAEs) up to 30 days after the last dose. Stage 2 follows Stage 1, with treatment on Day 1 and a 7-day follow-up period thereafter.
Participants by arm
| Arm | Count |
|---|---|
| Stage 1 (Double-blind): SAGE-547 and Placebo Participants who received a 12-hour IV infusion of SAGE 547, at ascending doses of 29, 58, and 86 μg/kg/h, 4 hours each, on Day 1 of Stage 1 (TP 1), received a 12-hour IV infusion of SAGE-547 matched-placebo, on Day 10 of Stage 1 (TP 2), after a washout period of approximately 7 days. Participants who received a 12-hour IV infusion of SAGE-547 matched-placebo on Day 1 of Stage 1 (TP 1), received a 12-hour IV infusion of SAGE 547 at ascending doses of 29, 58, and 86 μg/kg/h, 4 hours each, on Day 10 of Stage 1 (TP 2), after a washout period of approximately 7 days. | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Stage 2 | Adverse Event | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Stage 1 (Double-blind): SAGE-547 and Placebo |
|---|---|
| Age, Continuous | 64.2 years STANDARD_DEVIATION 5.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants |
| Race/Ethnicity, Customized Other | 2 Participants |
| Race/Ethnicity, Customized White | 22 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 | 0 / 17 |
| other Total, other adverse events | 1 / 25 | 3 / 25 | 8 / 17 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 | 0 / 17 |
Outcome results
Primary
Stage 1: Change From Baseline (CFB) in Vital Signs Parameter - Supine Systolic Blood Pressure
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in supine systolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline (CFB) in Vital Signs Parameter - Supine Systolic Blood Pressure | CFB at 4 Hours | -2.5 millimeters of mercury (mmHg) | Standard Deviation 10.84 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline (CFB) in Vital Signs Parameter - Supine Systolic Blood Pressure | CFB at 12 Hours | -1.6 millimeters of mercury (mmHg) | Standard Deviation 10.44 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline (CFB) in Vital Signs Parameter - Supine Systolic Blood Pressure | CFB at 8 Hours | -3.9 millimeters of mercury (mmHg) | Standard Deviation 11.64 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline (CFB) in Vital Signs Parameter - Supine Systolic Blood Pressure | CFB at 12-hour Follow-up | 5.6 millimeters of mercury (mmHg) | Standard Deviation 8.68 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline (CFB) in Vital Signs Parameter - Supine Systolic Blood Pressure | Pre-infusion | 121.6 millimeters of mercury (mmHg) | Standard Deviation 11.58 |
| Stage 1: Placebo | Stage 1: Change From Baseline (CFB) in Vital Signs Parameter - Supine Systolic Blood Pressure | CFB at 12-hour Follow-up | 1.4 millimeters of mercury (mmHg) | Standard Deviation 11.85 |
| Stage 1: Placebo | Stage 1: Change From Baseline (CFB) in Vital Signs Parameter - Supine Systolic Blood Pressure | Pre-infusion | 120.2 millimeters of mercury (mmHg) | Standard Deviation 15.47 |
| Stage 1: Placebo | Stage 1: Change From Baseline (CFB) in Vital Signs Parameter - Supine Systolic Blood Pressure | CFB at 4 Hours | 4.0 millimeters of mercury (mmHg) | Standard Deviation 11.71 |
| Stage 1: Placebo | Stage 1: Change From Baseline (CFB) in Vital Signs Parameter - Supine Systolic Blood Pressure | CFB at 8 Hours | 3.5 millimeters of mercury (mmHg) | Standard Deviation 10.24 |
| Stage 1: Placebo | Stage 1: Change From Baseline (CFB) in Vital Signs Parameter - Supine Systolic Blood Pressure | CFB at 12 Hours | 7.6 millimeters of mercury (mmHg) | Standard Deviation 10.14 |
Primary
Stage 1: Change From Baseline in ECG Parameter - Heart Rate
ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in heart rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in ECG Parameter - Heart Rate | Pre-infusion | 65.0 bpm | Standard Deviation 9.7 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in ECG Parameter - Heart Rate | CFB at 4 Hours | -1.9 bpm | Standard Deviation 6.36 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in ECG Parameter - Heart Rate | CFB at 8 Hours | 3.3 bpm | Standard Deviation 6.46 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in ECG Parameter - Heart Rate | CFB at 12 Hours | 5.5 bpm | Standard Deviation 7.35 |
| Stage 1: Placebo | Stage 1: Change From Baseline in ECG Parameter - Heart Rate | CFB at 12 Hours | 4.6 bpm | Standard Deviation 7.34 |
| Stage 1: Placebo | Stage 1: Change From Baseline in ECG Parameter - Heart Rate | Pre-infusion | 65.0 bpm | Standard Deviation 9.09 |
| Stage 1: Placebo | Stage 1: Change From Baseline in ECG Parameter - Heart Rate | CFB at 8 Hours | 3.0 bpm | Standard Deviation 9.05 |
| Stage 1: Placebo | Stage 1: Change From Baseline in ECG Parameter - Heart Rate | CFB at 4 Hours | 0.2 bpm | Standard Deviation 4.33 |
Primary
Stage 1: Change From Baseline in ECG Parameter - PR Interval
ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in PR interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8,12 hours during infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in ECG Parameter - PR Interval | Pre-infusion | 168.0 msec |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in ECG Parameter - PR Interval | CFB at 4 Hours | 0.0 msec |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in ECG Parameter - PR Interval | CFB at 8 Hours | -3.0 msec |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in ECG Parameter - PR Interval | CFB at 12 Hours | -4.0 msec |
| Stage 1: Placebo | Stage 1: Change From Baseline in ECG Parameter - PR Interval | CFB at 12 Hours | -6.0 msec |
| Stage 1: Placebo | Stage 1: Change From Baseline in ECG Parameter - PR Interval | Pre-infusion | 170.0 msec |
| Stage 1: Placebo | Stage 1: Change From Baseline in ECG Parameter - PR Interval | CFB at 8 Hours | -2.0 msec |
| Stage 1: Placebo | Stage 1: Change From Baseline in ECG Parameter - PR Interval | CFB at 4 Hours | -4.0 msec |
Primary
Stage 1: Change From Baseline in ECG Parameter - QRS Duration
ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QRS duration is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in ECG Parameter - QRS Duration | CFB at 4 Hours | 0.0 msec |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in ECG Parameter - QRS Duration | Pre-infusion | 86.0 msec |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in ECG Parameter - QRS Duration | CFB at 8 Hours | 0.0 msec |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in ECG Parameter - QRS Duration | CFB at 12 Hours | 0.0 msec |
| Stage 1: Placebo | Stage 1: Change From Baseline in ECG Parameter - QRS Duration | CFB at 12 Hours | 0.0 msec |
| Stage 1: Placebo | Stage 1: Change From Baseline in ECG Parameter - QRS Duration | CFB at 8 Hours | 0.0 msec |
| Stage 1: Placebo | Stage 1: Change From Baseline in ECG Parameter - QRS Duration | Pre-infusion | 85.0 msec |
| Stage 1: Placebo | Stage 1: Change From Baseline in ECG Parameter - QRS Duration | CFB at 4 Hours | 0.0 msec |
Primary
Stage 1: Change From Baseline in ECG Parameter - QTcB Interval
ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QTcB interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in ECG Parameter - QTcB Interval | Pre-infusion | 412.0 msec |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in ECG Parameter - QTcB Interval | CFB at 4 Hours | -1.0 msec |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in ECG Parameter - QTcB Interval | CFB at 8 Hours | 5.0 msec |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in ECG Parameter - QTcB Interval | CFB at 12 Hours | 4.0 msec |
| Stage 1: Placebo | Stage 1: Change From Baseline in ECG Parameter - QTcB Interval | CFB at 12 Hours | -1.0 msec |
| Stage 1: Placebo | Stage 1: Change From Baseline in ECG Parameter - QTcB Interval | Pre-infusion | 413.0 msec |
| Stage 1: Placebo | Stage 1: Change From Baseline in ECG Parameter - QTcB Interval | CFB at 8 Hours | 0.0 msec |
| Stage 1: Placebo | Stage 1: Change From Baseline in ECG Parameter - QTcB Interval | CFB at 4 Hours | 1.0 msec |
Primary
Stage 1: Change From Baseline in ECG Parameter - QTcF Interval
ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QTcF interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in ECG Parameter - QTcF Interval | Pre-infusion | 404.0 msec |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in ECG Parameter - QTcF Interval | CFB at 4 Hours | 2.0 msec |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in ECG Parameter - QTcF Interval | CFB at 8 Hours | 1.0 msec |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in ECG Parameter - QTcF Interval | CFB at 12 Hours | 1.0 msec |
| Stage 1: Placebo | Stage 1: Change From Baseline in ECG Parameter - QTcF Interval | CFB at 12 Hours | -7.0 msec |
| Stage 1: Placebo | Stage 1: Change From Baseline in ECG Parameter - QTcF Interval | Pre-infusion | 404.0 msec |
| Stage 1: Placebo | Stage 1: Change From Baseline in ECG Parameter - QTcF Interval | CFB at 8 Hours | -3.0 msec |
| Stage 1: Placebo | Stage 1: Change From Baseline in ECG Parameter - QTcF Interval | CFB at 4 Hours | 0.0 msec |
Primary
Stage 1: Change From Baseline in Electrocardiogram (ECG) Parameter - QT Interval
ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QT interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8,12 hours during infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Electrocardiogram (ECG) Parameter - QT Interval | Pre-infusion | 392.0 milliseconds (msec) |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Electrocardiogram (ECG) Parameter - QT Interval | CFB at 4 Hours | 3.0 milliseconds (msec) |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Electrocardiogram (ECG) Parameter - QT Interval | CFB at 8 Hours | -8.0 milliseconds (msec) |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Electrocardiogram (ECG) Parameter - QT Interval | CFB at 12 Hours | -12.0 milliseconds (msec) |
| Stage 1: Placebo | Stage 1: Change From Baseline in Electrocardiogram (ECG) Parameter - QT Interval | CFB at 12 Hours | -14.0 milliseconds (msec) |
| Stage 1: Placebo | Stage 1: Change From Baseline in Electrocardiogram (ECG) Parameter - QT Interval | Pre-infusion | 394.0 milliseconds (msec) |
| Stage 1: Placebo | Stage 1: Change From Baseline in Electrocardiogram (ECG) Parameter - QT Interval | CFB at 8 Hours | -10.0 milliseconds (msec) |
| Stage 1: Placebo | Stage 1: Change From Baseline in Electrocardiogram (ECG) Parameter - QT Interval | CFB at 4 Hours | -2.0 milliseconds (msec) |
Primary
Stage 1: Change From Baseline in Hematology Parameter - Basophil Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in basophil levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. Overall number of participants analyzed = Number of participants analyzed in this outcome measure. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Hematology Parameter - Basophil Levels | Pre-infusion | 25.4 cells per microliter (cells/μL) | Standard Deviation 15.61 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Hematology Parameter - Basophil Levels | CFB at 12-hours Follow-up | 6.4 cells per microliter (cells/μL) | Standard Deviation 17.06 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Hematology Parameter - Basophil Levels | Pre-infusion | 27.2 cells per microliter (cells/μL) | Standard Deviation 20.45 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Hematology Parameter - Basophil Levels | CFB at 12-hours Follow-up | -8.3 cells per microliter (cells/μL) | Standard Deviation 21.83 |
Primary
Stage 1: Change From Baseline in Hematology Parameter - Eosinophil Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in eosinophil levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. Overall number of participants analyzed = Number of participants analyzed in this outcome measure. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Hematology Parameter - Eosinophil Levels | Pre-infusion | 158.8 cells/μL | Standard Deviation 77.53 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Hematology Parameter - Eosinophil Levels | CFB at 12-hours Follow-up | 11.5 cells/μL | Standard Deviation 45.21 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Hematology Parameter - Eosinophil Levels | Pre-infusion | 140.3 cells/μL | Standard Deviation 109.72 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Hematology Parameter - Eosinophil Levels | CFB at 12-hours Follow-up | 42.5 cells/μL | Standard Deviation 47.48 |
Primary
Stage 1: Change From Baseline in Hematology Parameter - Erythrocyte Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in erythrocyte levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Hematology Parameter - Erythrocyte Levels | Pre-infusion | 4.437 10^6 cells per microliter(10^6 cells/μL) | Standard Deviation 0.4032 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Hematology Parameter - Erythrocyte Levels | CFB at 12-hours Follow-up | 0.09 10^6 cells per microliter(10^6 cells/μL) | Standard Deviation 0.223 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Hematology Parameter - Erythrocyte Levels | Pre-infusion | 4.474 10^6 cells per microliter(10^6 cells/μL) | Standard Deviation 0.4119 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Hematology Parameter - Erythrocyte Levels | CFB at 12-hours Follow-up | 0.07 10^6 cells per microliter(10^6 cells/μL) | Standard Deviation 0.271 |
Primary
Stage 1: Change From Baseline in Hematology Parameter - Erythrocytes Mean Corpuscular Volume Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in erythrocytes mean corpuscular volume levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Hematology Parameter - Erythrocytes Mean Corpuscular Volume Levels | Pre-infusion | 91.71 femtoliter (fL) | Standard Deviation 3.774 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Hematology Parameter - Erythrocytes Mean Corpuscular Volume Levels | CFB at 12-hours Follow-up | 0.30 femtoliter (fL) | Standard Deviation 0.81 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Hematology Parameter - Erythrocytes Mean Corpuscular Volume Levels | Pre-infusion | 91.72 femtoliter (fL) | Standard Deviation 3.78 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Hematology Parameter - Erythrocytes Mean Corpuscular Volume Levels | CFB at 12-hours Follow-up | -0.03 femtoliter (fL) | Standard Deviation 0.833 |
Primary
Stage 1: Change From Baseline in Hematology Parameter - Hematocrit Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in hematocrit levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Hematology Parameter - Hematocrit Levels | Pre-infusion | 40.66 percentage of cells | Standard Deviation 3.463 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Hematology Parameter - Hematocrit Levels | CFB at 12-hours Follow-up | 1.02 percentage of cells | Standard Deviation 2.013 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Hematology Parameter - Hematocrit Levels | Pre-infusion | 40.97 percentage of cells | Standard Deviation 3.453 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Hematology Parameter - Hematocrit Levels | CFB at 12-hours Follow-up | 0.67 percentage of cells | Standard Deviation 2.494 |
Primary
Stage 1: Change From Baseline in Hematology Parameter - Hemoglobin Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in hemoglobin levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Hematology Parameter - Hemoglobin Levels | Pre-infusion | 13.56 g/dL | Standard Deviation 1.276 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Hematology Parameter - Hemoglobin Levels | CFB at 12-hours Follow-up | 0.34 g/dL | Standard Deviation 0.733 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Hematology Parameter - Hemoglobin Levels | Pre-infusion | 13.63 g/dL | Standard Deviation 1.179 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Hematology Parameter - Hemoglobin Levels | CFB at 12-hours Follow-up | 0.28 g/dL | Standard Deviation 0.768 |
Primary
Stage 1: Change From Baseline in Hematology Parameter - Leukocyte Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in leukocyte levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Hematology Parameter - Leukocyte Levels | Pre-infusion | 6.976 10^3 cells/μL | Standard Deviation 1.955 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Hematology Parameter - Leukocyte Levels | CFB at 12-hours Follow-up | -0.12 10^3 cells/μL | Standard Deviation 1.09 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Hematology Parameter - Leukocyte Levels | Pre-infusion | 6.972 10^3 cells/μL | Standard Deviation 2.1314 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Hematology Parameter - Leukocyte Levels | CFB at 12-hours Follow-up | -0.43 10^3 cells/μL | Standard Deviation 0.927 |
Primary
Stage 1: Change From Baseline in Hematology Parameter - Lymphocyte Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in lymphocyte levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. Overall number of participants analyzed = Number of participants analyzed in this outcome measure. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Hematology Parameter - Lymphocyte Levels | Pre-infusion | 1641.7 cells/μL | Standard Deviation 423.63 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Hematology Parameter - Lymphocyte Levels | CFB at 12-hours Follow-up | 176.5 cells/μL | Standard Deviation 244.63 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Hematology Parameter - Lymphocyte Levels | Pre-infusion | 1590.1 cells/μL | Standard Deviation 427.61 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Hematology Parameter - Lymphocyte Levels | CFB at 12-hours Follow-up | 100.3 cells/μL | Standard Deviation 310.99 |
Primary
Stage 1: Change From Baseline in Hematology Parameter - Mean Cell Hemoglobin Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in mean cell hemoglobin levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. Overall number of participants analyzed = Number of participants analyzed in this outcome measure. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Hematology Parameter - Mean Cell Hemoglobin Levels | Pre-infusion | 30.58 picograms (pg) | Standard Deviation 1.54 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Hematology Parameter - Mean Cell Hemoglobin Levels | CFB at 12-hours Follow-up | 0.18 picograms (pg) | Standard Deviation 0.468 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Hematology Parameter - Mean Cell Hemoglobin Levels | Pre-infusion | 30.90 picograms (pg) | Standard Deviation 1.76 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Hematology Parameter - Mean Cell Hemoglobin Levels | CFB at 12-hours Follow-up | -0.30 picograms (pg) | Standard Deviation 0.792 |
Primary
Stage 1: Change From Baseline in Hematology Parameter - Monocyte Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in monocyte levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. Overall number of participants analyzed = Number of participants analyzed in this outcome measure. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Hematology Parameter - Monocyte Levels | Pre-infusion | 480.5 cells/μL | Standard Deviation 264.68 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Hematology Parameter - Monocyte Levels | CFB at 12-hours Follow-up | -22.9 cells/μL | Standard Deviation 176.01 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Hematology Parameter - Monocyte Levels | Pre-infusion | 462.8 cells/μL | Standard Deviation 240.92 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Hematology Parameter - Monocyte Levels | CFB at 12-hours Follow-up | -40.3 cells/μL | Standard Deviation 113.21 |
Primary
Stage 1: Change From Baseline in Hematology Parameter - Neutrophil Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in neutrophil levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. Overall number of participants analyzed = Number of participants analyzed in this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Hematology Parameter - Neutrophil Levels | Pre-infusion | 4.510 10^3 cells/μL | Standard Deviation 1.2311 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Hematology Parameter - Neutrophil Levels | CFB at 12-hours Follow-up | -0.49 10^3 cells/μL | Standard Deviation 0.941 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Hematology Parameter - Neutrophil Levels | Pre-infusion | 4.781 10^3 cells/μL | Standard Deviation 1.6007 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Hematology Parameter - Neutrophil Levels | CFB at 12-hours Follow-up | -0.66 10^3 cells/μL | Standard Deviation 1.053 |
Primary
Stage 1: Change From Baseline in Hematology Parameter - Platelet Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. CFB in platelet levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Hematology Parameter - Platelet Levels | Pre-infusion | 212.5 10^3 cells per microliter(10^3 cells/μL) | Standard Deviation 40.56 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Hematology Parameter - Platelet Levels | CFB at 12-hours Follow-up | -11.7 10^3 cells per microliter(10^3 cells/μL) | Standard Deviation 45.02 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Hematology Parameter - Platelet Levels | Pre-infusion | 218.8 10^3 cells per microliter(10^3 cells/μL) | Standard Deviation 48.31 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Hematology Parameter - Platelet Levels | CFB at 12-hours Follow-up | -7.1 10^3 cells per microliter(10^3 cells/μL) | Standard Deviation 37.11 |
Primary
Stage 1: Change From Baseline in Serum Chemistry Parameter - Alanine Aminotransferase Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in alanine aminotransferase levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Serum Chemistry Parameter - Alanine Aminotransferase Levels | Pre-infusion | 22.0 units per liter (u/L) | Standard Deviation 12.15 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Serum Chemistry Parameter - Alanine Aminotransferase Levels | CFB at 12-hour Follow-up | -1.4 units per liter (u/L) | Standard Deviation 4.05 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Serum Chemistry Parameter - Alanine Aminotransferase Levels | Pre-infusion | 23.3 units per liter (u/L) | Standard Deviation 14.67 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Serum Chemistry Parameter - Alanine Aminotransferase Levels | CFB at 12-hour Follow-up | -2.7 units per liter (u/L) | Standard Deviation 5.69 |
Primary
Stage 1: Change From Baseline in Serum Chemistry Parameter - Albumin Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in albumin levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Serum Chemistry Parameter - Albumin Levels | Pre-infusion | 3.94 g/dL | Standard Deviation 0.26 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Serum Chemistry Parameter - Albumin Levels | CFB at 12-hour Follow-up | -0.06 g/dL | Standard Deviation 0.314 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Serum Chemistry Parameter - Albumin Levels | Pre-infusion | 3.95 g/dL | Standard Deviation 0.315 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Serum Chemistry Parameter - Albumin Levels | CFB at 12-hour Follow-up | -0.01 g/dL | Standard Deviation 0.276 |
Primary
Stage 1: Change From Baseline in Serum Chemistry Parameter - Alkaline Phosphatase Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in alkaline phosphatase levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. Overall number of participants analyzed = Number of participants analyzed in this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Serum Chemistry Parameter - Alkaline Phosphatase Levels | Pre-infusion | 69.1 u/L | Standard Deviation 13.97 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Serum Chemistry Parameter - Alkaline Phosphatase Levels | CFB at 12-hour Follow-up | -2.4 u/L | Standard Deviation 5.37 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Serum Chemistry Parameter - Alkaline Phosphatase Levels | Pre-infusion | 67.1 u/L | Standard Deviation 13.58 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Serum Chemistry Parameter - Alkaline Phosphatase Levels | CFB at 12-hour Follow-up | -0.4 u/L | Standard Deviation 6.83 |
Primary
Stage 1: Change From Baseline in Serum Chemistry Parameter - Aspartate Aminotransferase Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in aspartate aminotransferase levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Serum Chemistry Parameter - Aspartate Aminotransferase Levels | Pre-infusion | 19.2 u/L | Standard Deviation 6.31 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Serum Chemistry Parameter - Aspartate Aminotransferase Levels | CFB at 12-hour Follow-up | -0.7 u/L | Standard Deviation 3.92 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Serum Chemistry Parameter - Aspartate Aminotransferase Levels | Pre-infusion | 19.0 u/L | Standard Deviation 5.81 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Serum Chemistry Parameter - Aspartate Aminotransferase Levels | CFB at 12-hour Follow-up | -0.0 u/L | Standard Deviation 4.32 |
Primary
Stage 1: Change From Baseline in Serum Chemistry Parameter - Bicarbonate Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in bicarbonate levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Serum Chemistry Parameter - Bicarbonate Levels | Pre-infusion | 25.6 mmol/L | Standard Deviation 3.47 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Serum Chemistry Parameter - Bicarbonate Levels | CFB at 12-hour Follow-up | -0.4 mmol/L | Standard Deviation 2.71 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Serum Chemistry Parameter - Bicarbonate Levels | Pre-infusion | 25.6 mmol/L | Standard Deviation 2.87 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Serum Chemistry Parameter - Bicarbonate Levels | CFB at 12-hour Follow-up | -0.7 mmol/L | Standard Deviation 2.95 |
Primary
Stage 1: Change From Baseline in Serum Chemistry Parameter - Bilirubin Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in bilirubin levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Serum Chemistry Parameter - Bilirubin Levels | Pre-infusion | 0.44 mg/dL | Standard Deviation 0.231 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Serum Chemistry Parameter - Bilirubin Levels | CFB at 12-hour Follow-up | 0.04 mg/dL | Standard Deviation 0.144 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Serum Chemistry Parameter - Bilirubin Levels | Pre-infusion | 0.47 mg/dL | Standard Deviation 0.313 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Serum Chemistry Parameter - Bilirubin Levels | CFB at 12-hour Follow-up | 0.09 mg/dL | Standard Deviation 0.127 |
Primary
Stage 1: Change From Baseline in Serum Chemistry Parameter - Blood Urea Nitrogen Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in blood urea nitrogen levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Serum Chemistry Parameter - Blood Urea Nitrogen Levels | Pre-infusion | 18.1 mg/dL | Standard Deviation 4.6 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Serum Chemistry Parameter - Blood Urea Nitrogen Levels | CFB at 12-hour Follow-up | -0.4 mg/dL | Standard Deviation 4.36 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Serum Chemistry Parameter - Blood Urea Nitrogen Levels | Pre-infusion | 17.9 mg/dL | Standard Deviation 5.73 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Serum Chemistry Parameter - Blood Urea Nitrogen Levels | CFB at 12-hour Follow-up | -0.3 mg/dL | Standard Deviation 3.08 |
Primary
Stage 1: Change From Baseline in Serum Chemistry Parameter - Calcium Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in calcium levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Serum Chemistry Parameter - Calcium Levels | Pre-infusion | 9.07 milligrams per deciliter (mg/dL) | Standard Deviation 0.366 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Serum Chemistry Parameter - Calcium Levels | CFB at 12-hour Follow-up | -0.11 milligrams per deciliter (mg/dL) | Standard Deviation 0.492 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Serum Chemistry Parameter - Calcium Levels | Pre-infusion | 9.08 milligrams per deciliter (mg/dL) | Standard Deviation 0.376 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Serum Chemistry Parameter - Calcium Levels | CFB at 12-hour Follow-up | -0.12 milligrams per deciliter (mg/dL) | Standard Deviation 0.393 |
Primary
Stage 1: Change From Baseline in Serum Chemistry Parameter - Chloride Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in chloride levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Serum Chemistry Parameter - Chloride Levels | Pre-infusion | 106.4 mmol/L | Standard Deviation 3.34 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Serum Chemistry Parameter - Chloride Levels | CFB at 12-hour Follow-up | -0.2 mmol/L | Standard Deviation 2.54 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Serum Chemistry Parameter - Chloride Levels | Pre-infusion | 105.8 mmol/L | Standard Deviation 3 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Serum Chemistry Parameter - Chloride Levels | CFB at 12-hour Follow-up | -0.2 mmol/L | Standard Deviation 2 |
Primary
Stage 1: Change From Baseline in Serum Chemistry Parameter - Cholesterol Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in cholesterol levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. Overall number of participants analyzed = Number of participants analyzed in this outcome measure. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Serum Chemistry Parameter - Cholesterol Levels | Pre-infusion | 183.0 mg/dL | Standard Deviation 32.77 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Serum Chemistry Parameter - Cholesterol Levels | CFB at 12-hour Follow-up | 0.4 mg/dL | Standard Deviation 14.01 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Serum Chemistry Parameter - Cholesterol Levels | Pre-infusion | 183.4 mg/dL | Standard Deviation 24.63 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Serum Chemistry Parameter - Cholesterol Levels | CFB at 12-hour Follow-up | 2.1 mg/dL | Standard Deviation 20.84 |
Primary
Stage 1: Change From Baseline in Serum Chemistry Parameter - Creatine Kinase Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in creatinine kinase levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. Overall number of participants analyzed = Number of participants analyzed in this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Serum Chemistry Parameter - Creatine Kinase Levels | Pre-infusion | 100.5 u/L | Standard Deviation 71.25 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Serum Chemistry Parameter - Creatine Kinase Levels | CFB at 12-hour Follow-up | -20.6 u/L | Standard Deviation 25.57 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Serum Chemistry Parameter - Creatine Kinase Levels | Pre-infusion | 124.0 u/L | Standard Deviation 188.98 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Serum Chemistry Parameter - Creatine Kinase Levels | CFB at 12-hour Follow-up | -36.2 u/L | Standard Deviation 90.71 |
Primary
Stage 1: Change From Baseline in Serum Chemistry Parameter - Creatinine Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in creatinine levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Serum Chemistry Parameter - Creatinine Levels | Pre-infusion | 0.940 mg/dL | Standard Deviation 0.248 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Serum Chemistry Parameter - Creatinine Levels | CFB at 12-hour Follow-up | -0.07 mg/dL | Standard Deviation 0.104 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Serum Chemistry Parameter - Creatinine Levels | Pre-infusion | 0.951 mg/dL | Standard Deviation 0.2912 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Serum Chemistry Parameter - Creatinine Levels | CFB at 12-hour Follow-up | -0.09 mg/dL | Standard Deviation 0.128 |
Primary
Stage 1: Change From Baseline in Serum Chemistry Parameter - Gamma Glutamyl Transferase Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in gamma glutamyl transferase levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 Stage 1.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Serum Chemistry Parameter - Gamma Glutamyl Transferase Levels | Pre-infusion | 27.0 u/L | Standard Deviation 24.32 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Serum Chemistry Parameter - Gamma Glutamyl Transferase Levels | CFB at 12-hour Follow-up | 0.0 u/L | Standard Deviation 4.16 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Serum Chemistry Parameter - Gamma Glutamyl Transferase Levels | Pre-infusion | 25.2 u/L | Standard Deviation 21.4 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Serum Chemistry Parameter - Gamma Glutamyl Transferase Levels | CFB at 12-hour Follow-up | 1.2 u/L | Standard Deviation 2.94 |
Primary
Stage 1: Change From Baseline in Serum Chemistry Parameter - Glucose Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in glucose levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Serum Chemistry Parameter - Glucose Levels | Pre-infusion | 108.0 mg/dL | Standard Deviation 34.29 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Serum Chemistry Parameter - Glucose Levels | CFB at 12-hour Follow-up | 0.0 mg/dL | Standard Deviation 38.89 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Serum Chemistry Parameter - Glucose Levels | Pre-infusion | 95.4 mg/dL | Standard Deviation 17.21 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Serum Chemistry Parameter - Glucose Levels | CFB at 12-hour Follow-up | 19.6 mg/dL | Standard Deviation 52.94 |
Primary
Stage 1: Change From Baseline in Serum Chemistry Parameter - Lactate Dehydrogenase Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in lactate dehydrogenase levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. Overall number of participants analyzed = Number of participants analyzed in this outcome measure. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Serum Chemistry Parameter - Lactate Dehydrogenase Levels | Pre-infusion | 167.9 u/L | Standard Deviation 32.75 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Serum Chemistry Parameter - Lactate Dehydrogenase Levels | CFB at 12-hour Follow-up | -16.6 u/L | Standard Deviation 15.59 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Serum Chemistry Parameter - Lactate Dehydrogenase Levels | Pre-infusion | 153.1 u/L | Standard Deviation 29.87 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Serum Chemistry Parameter - Lactate Dehydrogenase Levels | CFB at 12-hour Follow-up | -0.8 u/L | Standard Deviation 17.57 |
Primary
Stage 1: Change From Baseline in Serum Chemistry Parameter - Phosphate Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in phosphate levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Serum Chemistry Parameter - Phosphate Levels | Pre-infusion | 3.58 mg/dL | Standard Deviation 0.468 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Serum Chemistry Parameter - Phosphate Levels | CFB at 12-hour Follow-up | -0.16 mg/dL | Standard Deviation 0.481 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Serum Chemistry Parameter - Phosphate Levels | Pre-infusion | 3.52 mg/dL | Standard Deviation 0.551 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Serum Chemistry Parameter - Phosphate Levels | CFB at 12-hour Follow-up | -0.17 mg/dL | Standard Deviation 0.581 |
Primary
Stage 1: Change From Baseline in Serum Chemistry Parameter - Potassium Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in potassium levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Serum Chemistry Parameter - Potassium Levels | Pre-infusion | 4.18 mmol/L | Standard Deviation 0.273 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Serum Chemistry Parameter - Potassium Levels | CFB at 12-hour Follow-up | -0.00 mmol/L | Standard Deviation 0.301 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Serum Chemistry Parameter - Potassium Levels | Pre-infusion | 4.17 mmol/L | Standard Deviation 0.301 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Serum Chemistry Parameter - Potassium Levels | CFB at 12-hour Follow-up | 0.10 mmol/L | Standard Deviation 0.335 |
Primary
Stage 1: Change From Baseline in Serum Chemistry Parameter - Protein Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in protein levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Serum Chemistry Parameter - Protein Levels | Pre-infusion | 6.70 grams per deciliter (g/dL) | Standard Deviation 0.452 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Serum Chemistry Parameter - Protein Levels | CFB at 12-hour Follow-up | -0.08 grams per deciliter (g/dL) | Standard Deviation 0.456 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Serum Chemistry Parameter - Protein Levels | Pre-infusion | 6.66 grams per deciliter (g/dL) | Standard Deviation 0.39 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Serum Chemistry Parameter - Protein Levels | CFB at 12-hour Follow-up | 0.05 grams per deciliter (g/dL) | Standard Deviation 0.366 |
Primary
Stage 1: Change From Baseline in Serum Chemistry Parameter - Sodium Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in sodium levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Serum Chemistry Parameter - Sodium Levels | Pre-infusion | 140.4 millimoles per liter (mmol/L) | Standard Deviation 2.38 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Serum Chemistry Parameter - Sodium Levels | CFB at 12-hour Follow-up | -0.2 millimoles per liter (mmol/L) | Standard Deviation 2.19 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Serum Chemistry Parameter - Sodium Levels | Pre-infusion | 140.2 millimoles per liter (mmol/L) | Standard Deviation 2.35 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Serum Chemistry Parameter - Sodium Levels | CFB at 12-hour Follow-up | -0.6 millimoles per liter (mmol/L) | Standard Deviation 3.28 |
Primary
Stage 1: Change From Baseline in Serum Chemistry Parameter - Triglyceride Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in triglyceride levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. Overall number of participants analyzed = Number of participants analyzed in this outcome measure. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Serum Chemistry Parameter - Triglyceride Levels | Pre-infusion | 166.1 mg/dL | Standard Deviation 93.42 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Serum Chemistry Parameter - Triglyceride Levels | CFB at 12-hour Follow-up | -19.1 mg/dL | Standard Deviation 67.47 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Serum Chemistry Parameter - Triglyceride Levels | Pre-infusion | 168.4 mg/dL | Standard Deviation 77.72 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Serum Chemistry Parameter - Triglyceride Levels | CFB at 12-hour Follow-up | -25.1 mg/dL | Standard Deviation 45.41 |
Primary
Stage 1: Change From Baseline in Serum Chemistry Parameter - Urate Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. CFB in urate levels is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 12-hour follow-up post-infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1. Overall number of participants analyzed = Number of participants analyzed in this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Serum Chemistry Parameter - Urate Levels | Pre-infusion | 4.53 mg/dL | Standard Deviation 1.249 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Serum Chemistry Parameter - Urate Levels | CFB at 12-hour Follow-up | 0.05 mg/dL | Standard Deviation 0.532 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Serum Chemistry Parameter - Urate Levels | Pre-infusion | 4.71 mg/dL | Standard Deviation 1.366 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Serum Chemistry Parameter - Urate Levels | CFB at 12-hour Follow-up | -0.04 mg/dL | Standard Deviation 0.317 |
Primary
Stage 1: Change From Baseline in Vital Signs Parameter - Respiratory Rate
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in respiratory rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Vital Signs Parameter - Respiratory Rate | CFB at 4 Hours | 0.4 breaths per minute (breaths/min) | Standard Deviation 2.55 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Vital Signs Parameter - Respiratory Rate | CFB at 12 Hours | 1.0 breaths per minute (breaths/min) | Standard Deviation 2.3 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Vital Signs Parameter - Respiratory Rate | CFB at 8 Hours | 0.7 breaths per minute (breaths/min) | Standard Deviation 2.43 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Vital Signs Parameter - Respiratory Rate | CFB at 12-hour Follow-up | 0.4 breaths per minute (breaths/min) | Standard Deviation 1.7 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Vital Signs Parameter - Respiratory Rate | Pre-infusion | 16.0 breaths per minute (breaths/min) | Standard Deviation 1.53 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Vital Signs Parameter - Respiratory Rate | CFB at 12-hour Follow-up | 0.2 breaths per minute (breaths/min) | Standard Deviation 1.31 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Vital Signs Parameter - Respiratory Rate | Pre-infusion | 16.3 breaths per minute (breaths/min) | Standard Deviation 1.46 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Vital Signs Parameter - Respiratory Rate | CFB at 4 Hours | -0.2 breaths per minute (breaths/min) | Standard Deviation 1.52 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Vital Signs Parameter - Respiratory Rate | CFB at 8 Hours | 0.3 breaths per minute (breaths/min) | Standard Deviation 2.3 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Vital Signs Parameter - Respiratory Rate | CFB at 12 Hours | 0.4 breaths per minute (breaths/min) | Standard Deviation 2.04 |
Primary
Stage 1: Change From Baseline in Vital Signs Parameter - Standing Diastolic Blood Pressure
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in standing diastolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Vital Signs Parameter - Standing Diastolic Blood Pressure | CFB at 4 Hours | -1.2 mmHg | Standard Deviation 8.86 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Vital Signs Parameter - Standing Diastolic Blood Pressure | CFB at 12 Hours | 1.0 mmHg | Standard Deviation 9.53 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Vital Signs Parameter - Standing Diastolic Blood Pressure | CFB at 8 Hours | -2.1 mmHg | Standard Deviation 9.03 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Vital Signs Parameter - Standing Diastolic Blood Pressure | CFB at 12-hour Follow-up | 2.7 mmHg | Standard Deviation 9.85 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Vital Signs Parameter - Standing Diastolic Blood Pressure | Pre-infusion | 76.2 mmHg | Standard Deviation 10.2 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Vital Signs Parameter - Standing Diastolic Blood Pressure | CFB at 12-hour Follow-up | 0.9 mmHg | Standard Deviation 6.65 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Vital Signs Parameter - Standing Diastolic Blood Pressure | Pre-infusion | 78.9 mmHg | Standard Deviation 11.84 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Vital Signs Parameter - Standing Diastolic Blood Pressure | CFB at 4 Hours | -3.1 mmHg | Standard Deviation 6.81 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Vital Signs Parameter - Standing Diastolic Blood Pressure | CFB at 8 Hours | -2.6 mmHg | Standard Deviation 7.34 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Vital Signs Parameter - Standing Diastolic Blood Pressure | CFB at 12 Hours | 0.6 mmHg | Standard Deviation 9.31 |
Primary
Stage 1: Change From Baseline in Vital Signs Parameter - Standing Heart Rate
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in standing heart rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Vital Signs Parameter - Standing Heart Rate | CFB at 4 Hours | 0.0 bpm | Standard Deviation 7.13 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Vital Signs Parameter - Standing Heart Rate | CFB at 12 Hours | 5.4 bpm | Standard Deviation 11.84 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Vital Signs Parameter - Standing Heart Rate | CFB at 8 Hours | 3.0 bpm | Standard Deviation 7.55 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Vital Signs Parameter - Standing Heart Rate | CFB at 12-hour Follow-up | 3.8 bpm | Standard Deviation 8.15 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Vital Signs Parameter - Standing Heart Rate | Pre-infusion | 72.0 bpm | Standard Deviation 9.66 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Vital Signs Parameter - Standing Heart Rate | CFB at 12-hour Follow-up | -1.5 bpm | Standard Deviation 9.38 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Vital Signs Parameter - Standing Heart Rate | Pre-infusion | 75.6 bpm | Standard Deviation 13.7 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Vital Signs Parameter - Standing Heart Rate | CFB at 4 Hours | -1.0 bpm | Standard Deviation 9.17 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Vital Signs Parameter - Standing Heart Rate | CFB at 8 Hours | -0.0 bpm | Standard Deviation 10.22 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Vital Signs Parameter - Standing Heart Rate | CFB at 12 Hours | 3.4 bpm | Standard Deviation 8.23 |
Primary
Stage 1: Change From Baseline in Vital Signs Parameter - Standing Systolic Blood Pressure
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in standing systolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1 .
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Vital Signs Parameter - Standing Systolic Blood Pressure | CFB at 4 Hours | -2.2 mmHg | Standard Deviation 10.7 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Vital Signs Parameter - Standing Systolic Blood Pressure | CFB at 12 Hours | 2.0 mmHg | Standard Deviation 12.65 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Vital Signs Parameter - Standing Systolic Blood Pressure | CFB at 8 Hours | -2.7 mmHg | Standard Deviation 13.23 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Vital Signs Parameter - Standing Systolic Blood Pressure | CFB at 12-hour Follow-up | 5.0 mmHg | Standard Deviation 15.82 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Vital Signs Parameter - Standing Systolic Blood Pressure | Pre-infusion | 118.0 mmHg | Standard Deviation 17.27 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Vital Signs Parameter - Standing Systolic Blood Pressure | CFB at 12-hour Follow-up | 1.7 mmHg | Standard Deviation 10.76 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Vital Signs Parameter - Standing Systolic Blood Pressure | Pre-infusion | 119.1 mmHg | Standard Deviation 15 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Vital Signs Parameter - Standing Systolic Blood Pressure | CFB at 4 Hours | 1.7 mmHg | Standard Deviation 12.48 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Vital Signs Parameter - Standing Systolic Blood Pressure | CFB at 8 Hours | 1.0 mmHg | Standard Deviation 12.87 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Vital Signs Parameter - Standing Systolic Blood Pressure | CFB at 12 Hours | 7.8 mmHg | Standard Deviation 11.48 |
Primary
Stage 1: Change From Baseline in Vital Signs Parameter - Supine Diastolic Blood Pressure
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in supine diastolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Vital Signs Parameter - Supine Diastolic Blood Pressure | CFB at 4 Hours | -2.3 mmHg | Standard Deviation 9.85 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Vital Signs Parameter - Supine Diastolic Blood Pressure | CFB at 12 Hours | 0.4 mmHg | Standard Deviation 8.33 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Vital Signs Parameter - Supine Diastolic Blood Pressure | CFB at 8 Hours | -2.0 mmHg | Standard Deviation 6.79 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Vital Signs Parameter - Supine Diastolic Blood Pressure | CFB at 12-hour Follow-up | 2.0 mmHg | Standard Deviation 8.17 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Vital Signs Parameter - Supine Diastolic Blood Pressure | Pre-infusion | 74.3 mmHg | Standard Deviation 8.9 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Vital Signs Parameter - Supine Diastolic Blood Pressure | CFB at 12-hour Follow-up | 0.8 mmHg | Standard Deviation 9.68 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Vital Signs Parameter - Supine Diastolic Blood Pressure | Pre-infusion | 75.0 mmHg | Standard Deviation 11.24 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Vital Signs Parameter - Supine Diastolic Blood Pressure | CFB at 4 Hours | -0.6 mmHg | Standard Deviation 6.1 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Vital Signs Parameter - Supine Diastolic Blood Pressure | CFB at 8 Hours | -0.7 mmHg | Standard Deviation 8.27 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Vital Signs Parameter - Supine Diastolic Blood Pressure | CFB at 12 Hours | 1.2 mmHg | Standard Deviation 9.69 |
Primary
Stage 1: Change From Baseline in Vital Signs Parameter - Supine Heart Rate
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in supine heart rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Vital Signs Parameter - Supine Heart Rate | CFB at 4 Hours | -1.4 beats per minute (bpm) | Standard Deviation 7.52 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Vital Signs Parameter - Supine Heart Rate | CFB at 12 Hours | 5.0 beats per minute (bpm) | Standard Deviation 8.67 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Vital Signs Parameter - Supine Heart Rate | CFB at 8 Hours | 2.0 beats per minute (bpm) | Standard Deviation 6.37 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Vital Signs Parameter - Supine Heart Rate | CFB at 12-hour Follow-up | 2.9 beats per minute (bpm) | Standard Deviation 9.17 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Vital Signs Parameter - Supine Heart Rate | Pre-infusion | 66.0 beats per minute (bpm) | Standard Deviation 9.7 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Vital Signs Parameter - Supine Heart Rate | CFB at 12-hour Follow-up | -2.3 beats per minute (bpm) | Standard Deviation 8.96 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Vital Signs Parameter - Supine Heart Rate | Pre-infusion | 69.0 beats per minute (bpm) | Standard Deviation 12.99 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Vital Signs Parameter - Supine Heart Rate | CFB at 4 Hours | -2.1 beats per minute (bpm) | Standard Deviation 10.39 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Vital Signs Parameter - Supine Heart Rate | CFB at 8 Hours | 1.3 beats per minute (bpm) | Standard Deviation 14.85 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Vital Signs Parameter - Supine Heart Rate | CFB at 12 Hours | 2.1 beats per minute (bpm) | Standard Deviation 11.23 |
Primary
Stage 1: Change From Baseline in Vital Signs Parameter - Temperature
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in temperature is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2): Pre-infusion (Baseline) and 4, 8, 12 hours during infusion and 12-hour follow-up post-infusion
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Vital Signs Parameter - Temperature | CFB at 4 Hours | -0.03 degree Celsius | Standard Deviation 0.22 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Vital Signs Parameter - Temperature | CFB at 12 Hours | -0.02 degree Celsius | Standard Deviation 0.2 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Vital Signs Parameter - Temperature | CFB at 8 Hours | -0.04 degree Celsius | Standard Deviation 0.16 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Vital Signs Parameter - Temperature | CFB at 12-hour Follow-up | -0.01 degree Celsius | Standard Deviation 0.22 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Vital Signs Parameter - Temperature | Pre-infusion | 36.62 degree Celsius | Standard Deviation 0.14 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Vital Signs Parameter - Temperature | CFB at 12-hour Follow-up | -0.00 degree Celsius | Standard Deviation 0.23 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Vital Signs Parameter - Temperature | Pre-infusion | 36.58 degree Celsius | Standard Deviation 0.16 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Vital Signs Parameter - Temperature | CFB at 4 Hours | 0.05 degree Celsius | Standard Deviation 0.25 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Vital Signs Parameter - Temperature | CFB at 8 Hours | 0.06 degree Celsius | Standard Deviation 0.28 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Vital Signs Parameter - Temperature | CFB at 12 Hours | 0.04 degree Celsius | Standard Deviation 0.23 |
Primary
Stage 1: Percentage of Participants With a Response of 'Yes' to Any Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation or Suicidal Behavior Item at Any Visit
The C-SSRS scale consisted of baseline evaluation that assessed lifetime experience of participants with suicidal ideation (SI) and suicidal behavior (SB) and postbaseline evaluation that focused on suicidality since last study visit. C-SSRS included yes or no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present \[from 1 (minor physical damage) to 5 (death), with 5 being most severe\]. C-SSRS SI items involved (a) wish to be dead, (b) non-specific active suicidal thoughts, (c) active SI with any methods (not plan) without intent to act, (d) active SI with some intent to act, without specific plan and (e) active SI with specific plan and intent. C-SSRS SB items involved (a) actual attempt, (b) engaged in non-suicidal self-injurious behavior, (c) interrupted attempt, (d) aborted attempt, (e) preparatory acts or behavior, (f) suicidal behavior. Only categories with data are reported.
Time frame: Stage 1: Pre-infusion on Day 1 of Stage 1 (Treatment Period 1) or on Day 10 of Stage 1 (Treatment Period 2)
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Percentage of Participants With a Response of 'Yes' to Any Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation or Suicidal Behavior Item at Any Visit | Suicidal Ideation: Wish to be Dead: Pre-infusion | 0 percentage of participants |
| Stage 1: SAGE-547 | Stage 1: Percentage of Participants With a Response of 'Yes' to Any Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation or Suicidal Behavior Item at Any Visit | Suicidal Ideation: Non-specific Active Suicidal Thoughts: Pre-infusion | 4.0 percentage of participants |
| Stage 1: SAGE-547 | Stage 1: Percentage of Participants With a Response of 'Yes' to Any Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation or Suicidal Behavior Item at Any Visit | Suicidal Behavior: Actual Attempt: Pre-infusion | 4.0 percentage of participants |
| Stage 1: Placebo | Stage 1: Percentage of Participants With a Response of 'Yes' to Any Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation or Suicidal Behavior Item at Any Visit | Suicidal Ideation: Wish to be Dead: Pre-infusion | 4.0 percentage of participants |
| Stage 1: Placebo | Stage 1: Percentage of Participants With a Response of 'Yes' to Any Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation or Suicidal Behavior Item at Any Visit | Suicidal Ideation: Non-specific Active Suicidal Thoughts: Pre-infusion | 0 percentage of participants |
| Stage 1: Placebo | Stage 1: Percentage of Participants With a Response of 'Yes' to Any Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation or Suicidal Behavior Item at Any Visit | Suicidal Behavior: Actual Attempt: Pre-infusion | 4.0 percentage of participants |
Primary
Stage 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was defined as an AE with start date/time after the start of initial infusion in each stage. An SAE is defined as an AE or suspected adverse reaction, which in the view of either the Investigator or Sponsor, results in any of the following outcomes: death; is life-threatening; inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant disability or incapacity; congenital anomaly or birth defect or other medically important condition.
Time frame: Stage 1: Up to 30 days after last infusion (up to Day 40)
Population: Safety population included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1 of Stage 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs | 12.0 percentage of participants |
| Stage 1: SAGE-547 | Stage 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 0 percentage of participants |
| Stage 1: Placebo | Stage 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs | 20.0 percentage of participants |
| Stage 1: Placebo | Stage 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 0 percentage of participants |
Primary
Stage 2: Absolute Values of Hematology Parameter - Basophil Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for basophil levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Overall number of participants analyzed = Number of participants analyzed in this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Hematology Parameter - Basophil Levels | Any Day in Screening Period (Day -7 up to Day -1) | 35.3 cells/μL | Standard Deviation 20.7 |
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Hematology Parameter - Basophil Levels | Any Day in 7-day Follow-up | 45.3 cells/μL | Standard Deviation 47.64 |
Primary
Stage 2: Absolute Values of Hematology Parameter - Eosinophil Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for eosinophil levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Overall number of participants analyzed = Number of participants analyzed in this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Hematology Parameter - Eosinophil Levels | Any Day in Screening Period (Day -7 up to Day -1) | 87.2 cells/μL | Standard Deviation 40.49 |
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Hematology Parameter - Eosinophil Levels | Any Day in 7-day Follow-up | 99.8 cells/μL | Standard Deviation 75.37 |
Primary
Stage 2: Absolute Values of Hematology Parameter - Erythrocyte Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for erythrocyte levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Hematology Parameter - Erythrocyte Levels | Any Day in Screening Period (Day -7 up to Day -1) | 4.925 10^6 cells/μL | Standard Deviation 0.4173 |
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Hematology Parameter - Erythrocyte Levels | Any Day in 7-day Follow-up | 4.735 10^6 cells/μL | Standard Deviation 0.5289 |
Primary
Stage 2: Absolute Values of Hematology Parameter - Erythrocytes Mean Corpuscular Volume Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for erythrocytes mean corpuscular volume levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Hematology Parameter - Erythrocytes Mean Corpuscular Volume Levels | Any Day in Screening Period (Day -7 up to Day -1) | 91.59 fL | Standard Deviation 5.264 |
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Hematology Parameter - Erythrocytes Mean Corpuscular Volume Levels | Any Day in 7-day Follow-up | 91.43 fL | Standard Deviation 4.718 |
Primary
Stage 2: Absolute Values of Hematology Parameter - Hematocrit Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for hematocrit levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Hematology Parameter - Hematocrit Levels | Any Day in Screening Period (Day -7 up to Day -1) | 45.04 percentage of cells | Standard Deviation 4.23 |
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Hematology Parameter - Hematocrit Levels | Any Day in 7-day Follow-up | 43.28 percentage of cells | Standard Deviation 5.128 |
Primary
Stage 2: Absolute Values of Hematology Parameter - Hemoglobin Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for hemoglobin levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Hematology Parameter - Hemoglobin Levels | Any Day in Screening Period (Day -7 up to Day -1) | 14.74 g/dL | Standard Deviation 1.419 |
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Hematology Parameter - Hemoglobin Levels | Any Day in 7-day Follow-up | 14.11 g/dL | Standard Deviation 1.684 |
Primary
Stage 2: Absolute Values of Hematology Parameter - Leukocyte Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for leukocyte levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Hematology Parameter - Leukocyte Levels | Any Day in Screening Period (Day -7 up to Day -1) | 6.928 10^3 cells/μL | Standard Deviation 1.7603 |
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Hematology Parameter - Leukocyte Levels | Any Day in 7-day Follow-up | 6.688 10^3 cells/μL | Standard Deviation 1.5791 |
Primary
Stage 2: Absolute Values of Hematology Parameter - Lymphocyte Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for lymphocyte levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Overall number of participants analyzed = Number of participants analyzed in this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Hematology Parameter - Lymphocyte Levels | Any Day in Screening Period (Day -7 up to Day -1) | 2080.0 cells/μL | Standard Deviation 908.52 |
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Hematology Parameter - Lymphocyte Levels | Any Day in 7-day Follow-up | 1871.8 cells/μL | Standard Deviation 858.64 |
Primary
Stage 2: Absolute Values of Hematology Parameter - Mean Cell Hemoglobin
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for mean cell hemoglobin levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Overall number of participants analyzed = Number of participants analyzed in this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Hematology Parameter - Mean Cell Hemoglobin | Any Day in Screening Period (Day -7 up to Day -1) | 29.93 pg | Standard Deviation 2.89 |
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Hematology Parameter - Mean Cell Hemoglobin | Any Day in 7-day Follow-up | 29.97 pg | Standard Deviation 2.809 |
Primary
Stage 2: Absolute Values of Hematology Parameter - Monocyte Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for monocyte levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Overall number of participants analyzed = Number of participants analyzed in this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Hematology Parameter - Monocyte Levels | Any Day in Screening Period (Day -7 up to Day -1) | 499.8 cells/μL | Standard Deviation 190.38 |
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Hematology Parameter - Monocyte Levels | Any Day in 7-day Follow-up | 426.7 cells/μL | Standard Deviation 133.11 |
Primary
Stage 2: Absolute Values of Hematology Parameter - Neutrophil Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for neutrophil levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Overall number of participants analyzed = Number of participants analyzed in this outcome measure. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Hematology Parameter - Neutrophil Levels | Any Day in Screening Period (Day -7 up to Day -1) | 4.049 10^3 cells/μL | Standard Deviation 0.8958 |
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Hematology Parameter - Neutrophil Levels | Any Day in 7-day Follow-up | 4.176 10^3 cells/μL | Standard Deviation 0.8065 |
Primary
Stage 2: Absolute Values of Hematology Parameter - Platelet Levels
Hematology parameters included hemoglobin, hematocrit, platelets, erythrocytes, neutrophils, basophils, eosinophils, monocytes, lymphocytes, leukocytes, erythrocytes mean corpuscular volume, and mean cell hemoglobin. Absolute values for platelet levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Hematology Parameter - Platelet Levels | Any Day in Screening Period (Day -7 up to Day -1) | 233.8 10^3 cells/μL | Standard Deviation 48.03 |
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Hematology Parameter - Platelet Levels | Any Day in 7-day Follow-up | 230.5 10^3 cells/μL | Standard Deviation 45.93 |
Primary
Stage 2: Absolute Values of Serum Chemistry Parameter - Alanine Aminotransferase Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for alanine aminotransferase levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Serum Chemistry Parameter - Alanine Aminotransferase Levels | Any Day in Screening Period (Day -7 up to Day -1) | 23.1 u/L | Standard Deviation 11.81 |
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Serum Chemistry Parameter - Alanine Aminotransferase Levels | Any Day in 7-day Follow-up | 23.6 u/L | Standard Deviation 13.06 |
Primary
Stage 2: Absolute Values of Serum Chemistry Parameter - Albumin Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for albumin levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Serum Chemistry Parameter - Albumin Levels | Any Day in Screening Period (Day -7 up to Day -1) | 4.03 g/dL | Standard Deviation 0.331 |
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Serum Chemistry Parameter - Albumin Levels | Any Day in 7-day Follow-up | 3.92 g/dL | Standard Deviation 0.299 |
Primary
Stage 2: Absolute Values of Serum Chemistry Parameter - Alkaline Phosphatase Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for alkaline phosphatase levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Serum Chemistry Parameter - Alkaline Phosphatase Levels | Any Day in Screening Period (Day -7 up to Day -1) | 71.1 u/L | Standard Deviation 13.99 |
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Serum Chemistry Parameter - Alkaline Phosphatase Levels | Any Day in 7-day Follow-up | 71.4 u/L | Standard Deviation 14.33 |
Primary
Stage 2: Absolute Values of Serum Chemistry Parameter - Aspartate Aminotransferase Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for aspartate aminotransferase levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Serum Chemistry Parameter - Aspartate Aminotransferase Levels | Any Day in Screening Period (Day -7 up to Day -1) | 15.8 u/L | Standard Deviation 4.82 |
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Serum Chemistry Parameter - Aspartate Aminotransferase Levels | Any Day in 7-day Follow-up | 15.6 u/L | Standard Deviation 5.66 |
Primary
Stage 2: Absolute Values of Serum Chemistry Parameter - Bicarbonate Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for bicarbonate levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Serum Chemistry Parameter - Bicarbonate Levels | Any Day in Screening Period (Day -7 up to Day -1) | 26.6 mmol/L | Standard Deviation 3.91 |
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Serum Chemistry Parameter - Bicarbonate Levels | Any Day in 7-day Follow-up | 26.3 mmol/L | Standard Deviation 3.6 |
Primary
Stage 2: Absolute Values of Serum Chemistry Parameter - Bilirubin Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for bilirubin levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Serum Chemistry Parameter - Bilirubin Levels | Any Day in Screening Period (Day -7 up to Day -1) | 0.58 mg/dL | Standard Deviation 0.354 |
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Serum Chemistry Parameter - Bilirubin Levels | Any Day in 7-day Follow-up | 0.57 mg/dL | Standard Deviation 0.463 |
Primary
Stage 2: Absolute Values of Serum Chemistry Parameter - Blood Urea Nitrogen Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for blood urea nitrogen levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Serum Chemistry Parameter - Blood Urea Nitrogen Levels | Any Day in Screening Period (Day -7 up to Day -1) | 17.3 mg/dL | Standard Deviation 4.31 |
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Serum Chemistry Parameter - Blood Urea Nitrogen Levels | Any Day in 7-day Follow-up | 16.6 mg/dL | Standard Deviation 3.37 |
Primary
Stage 2: Absolute Values of Serum Chemistry Parameter - Calcium Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for calcium levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Serum Chemistry Parameter - Calcium Levels | Any Day in Screening Period (Day -7 up to Day -1) | 9.19 mg/dL | Standard Deviation 0.302 |
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Serum Chemistry Parameter - Calcium Levels | Any Day in 7-day Follow-up | 9.12 mg/dL | Standard Deviation 0.268 |
Primary
Stage 2: Absolute Values of Serum Chemistry Parameter - Chloride Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for chloride levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Serum Chemistry Parameter - Chloride Levels | Any Day in Screening Period (Day -7 up to Day -1) | 103.8 mmol/L | Standard Deviation 2.79 |
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Serum Chemistry Parameter - Chloride Levels | Any Day in 7-day Follow-up | 104.2 mmol/L | Standard Deviation 2.54 |
Primary
Stage 2: Absolute Values of Serum Chemistry Parameter - Cholesterol Level
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for cholesterol levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Serum Chemistry Parameter - Cholesterol Level | Any Day in Screening Period (Day -7 up to Day -1) | 194.6 mg/dL | Standard Deviation 39.64 |
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Serum Chemistry Parameter - Cholesterol Level | Any Day in 7-day Follow-up | 179.7 mg/dL | Standard Deviation 33.94 |
Primary
Stage 2: Absolute Values of Serum Chemistry Parameter - Creatine Kinase Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for creatinine kinase levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Serum Chemistry Parameter - Creatine Kinase Levels | Any Day in Screening Period (Day -7 up to Day -1) | 83.9 u/L | Standard Deviation 32.51 |
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Serum Chemistry Parameter - Creatine Kinase Levels | Any Day in 7-day Follow-up | 85.9 u/L | Standard Deviation 44.45 |
Primary
Stage 2: Absolute Values of Serum Chemistry Parameter - Creatinine Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for creatinine levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Serum Chemistry Parameter - Creatinine Levels | Any Day in Screening Period (Day -7 up to Day -1) | 0.872 mg/dL | Standard Deviation 0.2302 |
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Serum Chemistry Parameter - Creatinine Levels | Any Day in 7-day Follow-up | 0.912 mg/dL | Standard Deviation 0.2234 |
Primary
Stage 2: Absolute Values of Serum Chemistry Parameter - Gamma Glutamyl Transferase Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for gamma glutamyl transferase levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Serum Chemistry Parameter - Gamma Glutamyl Transferase Levels | Any Day in Screening Period (Day -7 up to Day -1) | 26.8 u/L | Standard Deviation 21.72 |
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Serum Chemistry Parameter - Gamma Glutamyl Transferase Levels | Any Day in 7-day Follow-up | 28.3 u/L | Standard Deviation 19.65 |
Primary
Stage 2: Absolute Values of Serum Chemistry Parameter - Glucose Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for glucose levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Serum Chemistry Parameter - Glucose Levels | Any Day in Screening Period (Day -7 up to Day -1) | 108.1 mg/dL | Standard Deviation 60.88 |
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Serum Chemistry Parameter - Glucose Levels | Any Day in 7-day Follow-up | 112.8 mg/dL | Standard Deviation 71.74 |
Primary
Stage 2: Absolute Values of Serum Chemistry Parameter - Lactate Dehydrogenase Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for lactate dehydrogenase levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Serum Chemistry Parameter - Lactate Dehydrogenase Levels | Any Day in Screening Period (Day -7 up to Day -1) | 162.9 u/L | Standard Deviation 39.06 |
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Serum Chemistry Parameter - Lactate Dehydrogenase Levels | Any Day in 7-day Follow-up | 168.8 u/L | Standard Deviation 40.97 |
Primary
Stage 2: Absolute Values of Serum Chemistry Parameter - Phosphate Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for phosphate levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Serum Chemistry Parameter - Phosphate Levels | Any Day in Screening Period (Day -7 up to Day -1) | 3.36 mg/dL | Standard Deviation 0.436 |
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Serum Chemistry Parameter - Phosphate Levels | Any Day in 7-day Follow-up | 3.23 mg/dL | Standard Deviation 0.461 |
Primary
Stage 2: Absolute Values of Serum Chemistry Parameter - Potassium Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for potassium levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Serum Chemistry Parameter - Potassium Levels | Any Day in Screening Period (Day -7 up to Day -1) | 4.36 mmol/L | Standard Deviation 0.232 |
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Serum Chemistry Parameter - Potassium Levels | Any Day in 7-day Follow-up | 4.42 mmol/L | Standard Deviation 0.268 |
Primary
Stage 2: Absolute Values of Serum Chemistry Parameter - Protein Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for protein levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Serum Chemistry Parameter - Protein Levels | Any Day in Screening Period (Day -7 up to Day -1) | 7.05 g/dL | Standard Deviation 0.403 |
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Serum Chemistry Parameter - Protein Levels | Any Day in 7-day Follow-up | 6.80 g/dL | Standard Deviation 0.417 |
Primary
Stage 2: Absolute Values of Serum Chemistry Parameter - Sodium Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for sodium levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Serum Chemistry Parameter - Sodium Levels | Any Day in Screening Period (Day -7 up to Day -1) | 139.4 mmol/L | Standard Deviation 2.18 |
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Serum Chemistry Parameter - Sodium Levels | Any Day in 7-day Follow-up | 139.4 mmol/L | Standard Deviation 1.91 |
Primary
Stage 2: Absolute Values of Serum Chemistry Parameter - Triglyceride Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for triglyceride levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Serum Chemistry Parameter - Triglyceride Levels | Any Day in Screening Period (Day -7 up to Day -1) | 162.4 mg/dL | Standard Deviation 63.59 |
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Serum Chemistry Parameter - Triglyceride Levels | Any Day in 7-day Follow-up | 163.4 mg/dL | Standard Deviation 69.94 |
Primary
Stage 2: Absolute Values of Serum Chemistry Parameter - Urate Levels
Serum chemistry parameters included alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, sodium, potassium, calcium, chloride, bicarbonate, protein, glucose, lactate dehydrogenase, cholesterol, triglycerides, albumin, bilirubin, creatinine, blood urea nitrogen, alkaline phosphatase, creatinine kinase, phosphate, and urate. Absolute values for urate levels are reported in this outcome measure.
Time frame: Stage 2: Any day in Screening period (Day -7 up to Day -1) and any day in 7-day follow up
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Serum Chemistry Parameter - Urate Levels | Any Day in Screening Period (Day -7 up to Day -1) | 4.66 mg/dL | Standard Deviation 1.169 |
| Stage 1: SAGE-547 | Stage 2: Absolute Values of Serum Chemistry Parameter - Urate Levels | Any Day in 7-day Follow-up | 4.84 mg/dL | Standard Deviation 1.183 |
Primary
Stage 2: Change From Baseline in ECG Parameter - Heart Rate
ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in heart rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Stage 2 Day 1: Pre-infusion (Baseline) and 10 hours post-infusion
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in ECG Parameter - Heart Rate | Pre-infusion | 72.0 bpm | Standard Deviation 8.27 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in ECG Parameter - Heart Rate | CFB at 10 Hours | -0.4 bpm | Standard Deviation 5.97 |
Primary
Stage 2: Change From Baseline in ECG Parameter - PR Interval
ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in PR interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Stage 2 Day 1: Pre-infusion (Baseline) and 10 hours post-infusion
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in ECG Parameter - PR Interval | Pre-infusion | 144.0 msec |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in ECG Parameter - PR Interval | CFB at 10 Hours | 2.5 msec |
Primary
Stage 2: Change From Baseline in ECG Parameter - QRS Duration
ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QRS duration is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Stage 2 Day 1: Pre-infusion (Baseline) and 10 hours post-infusion
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in ECG Parameter - QRS Duration | Pre-infusion | 90.0 msec |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in ECG Parameter - QRS Duration | CFB at 10 Hours | 0.0 msec |
Primary
Stage 2: Change From Baseline in ECG Parameter - QTcB Interval
ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QTcB interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Stage 2 Day 1: Pre-infusion (Baseline) and 10 hours post-infusion
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in ECG Parameter - QTcB Interval | Pre-infusion | 421.0 msec |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in ECG Parameter - QTcB Interval | CFB at 10 Hours | 1.5 msec |
Primary
Stage 2: Change From Baseline in ECG Parameter - QTcF Interval
ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QTcF interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Stage 2 Day 1: Pre-infusion (Baseline) and 10 hours post-infusion
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in ECG Parameter - QTcF Interval | Pre-infusion | 406.0 msec |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in ECG Parameter - QTcF Interval | CFB at 10 Hours | 2.5 msec |
Primary
Stage 2: Change From Baseline in ECG Parameter - QT Interval
ECG parameters included QT interval, PR interval, QRS duration, QTcB interval, QTcF interval, and heart rate. CFB in QT interval is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Stage 2 Day 1: Pre-infusion (Baseline) and 10 hours post-infusion
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in ECG Parameter - QT Interval | Pre-infusion | 376.0 msec |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in ECG Parameter - QT Interval | CFB at 10 Hours | -1.0 msec |
Primary
Stage 2: Change From Baseline in Vital Signs Parameter - Respiratory Rate
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in respiratory rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Overall number of participants analyzed = Number of participants analyzed in this outcome measure. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Respiratory Rate | Pre-infusion | 16.9 breaths/min | Standard Deviation 1.75 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Respiratory Rate | CFB at 2 Hours | -0.5 breaths/min | Standard Deviation 1.81 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Respiratory Rate | CFB at 4 Hours | -0.4 breaths/min | Standard Deviation 2.22 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Respiratory Rate | CFB at 6 Hours | -0.9 breaths/min | Standard Deviation 2.31 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Respiratory Rate | CFB at 8 Hours | -0.4 breaths/min | Standard Deviation 1.82 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Respiratory Rate | CFB at 10 Hours | 0.3 breaths/min | Standard Deviation 1.24 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Respiratory Rate | CFB at 12 Hours | 0.5 breaths/min | Standard Deviation 2.13 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Respiratory Rate | CFB at 14 Hours | 0.1 breaths/min | Standard Deviation 2.33 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Respiratory Rate | CFB at 24 Hours | -0.5 breaths/min | Standard Deviation 2 |
Primary
Stage 2: Change From Baseline in Vital Signs Parameter - Standing Diastolic Blood Pressure
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in standing diastolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Standing Diastolic Blood Pressure | Pre-infusion | 78.9 mmHg | Standard Deviation 8.81 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Standing Diastolic Blood Pressure | CFB at 2 Hours | -5.6 mmHg | Standard Deviation 7.17 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Standing Diastolic Blood Pressure | CFB at 4 Hours | -4.5 mmHg | Standard Deviation 8.43 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Standing Diastolic Blood Pressure | CFB at 6 Hours | -4.1 mmHg | Standard Deviation 6.66 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Standing Diastolic Blood Pressure | CFB at 8 Hours | -4.7 mmHg | Standard Deviation 6.03 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Standing Diastolic Blood Pressure | CFB at 10 Hours | -4.3 mmHg | Standard Deviation 9.21 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Standing Diastolic Blood Pressure | CFB at 12 Hours | -1.3 mmHg | Standard Deviation 8.3 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Standing Diastolic Blood Pressure | CFB at 14 Hours | -0.6 mmHg | Standard Deviation 8.73 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Standing Diastolic Blood Pressure | CFB at 24 Hours | -1.5 mmHg | Standard Deviation 6.52 |
Primary
Stage 2: Change From Baseline in Vital Signs Parameter - Standing Heart Rate
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in standing heart rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Standing Heart Rate | Pre-infusion | 74.6 bpm | Standard Deviation 10.12 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Standing Heart Rate | CFB at 2 Hours | 1.2 bpm | Standard Deviation 9.25 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Standing Heart Rate | CFB at 4 Hours | 0.7 bpm | Standard Deviation 7.69 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Standing Heart Rate | CFB at 6 Hours | -1.2 bpm | Standard Deviation 7.06 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Standing Heart Rate | CFB at 8 Hours | 2.6 bpm | Standard Deviation 11.09 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Standing Heart Rate | CFB at 10 Hours | 3.5 bpm | Standard Deviation 8.53 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Standing Heart Rate | CFB at 12 Hours | -1.5 bpm | Standard Deviation 6.26 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Standing Heart Rate | CFB at 14 Hours | 2.3 bpm | Standard Deviation 10.02 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Standing Heart Rate | CFB at 24 Hours | 4.6 bpm | Standard Deviation 11.17 |
Primary
Stage 2: Change From Baseline in Vital Signs Parameter - Standing Systolic Blood Pressure
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in standing systolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Standing Systolic Blood Pressure | Pre-infusion | 120.1 mmHg | Standard Deviation 13.05 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Standing Systolic Blood Pressure | CFB at 2 Hours | -5.5 mmHg | Standard Deviation 15.98 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Standing Systolic Blood Pressure | CFB at 4 Hours | -5.9 mmHg | Standard Deviation 13.87 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Standing Systolic Blood Pressure | CFB at 6 Hours | -1.0 mmHg | Standard Deviation 16.84 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Standing Systolic Blood Pressure | CFB at 8 Hours | -2.9 mmHg | Standard Deviation 14.22 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Standing Systolic Blood Pressure | CFB at 10 Hours | -0.9 mmHg | Standard Deviation 16.49 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Standing Systolic Blood Pressure | CFB at 12 Hours | 10.2 mmHg | Standard Deviation 17.28 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Standing Systolic Blood Pressure | CFB at 14 Hours | 11.1 mmHg | Standard Deviation 18.98 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Standing Systolic Blood Pressure | CFB at 24 Hours | 2.9 mmHg | Standard Deviation 9.3 |
Primary
Stage 2: Change From Baseline in Vital Signs Parameter - Supine Diastolic Blood Pressure
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in supine diastolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Supine Diastolic Blood Pressure | Pre-infusion | 75.5 mmHg | Standard Deviation 7.63 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Supine Diastolic Blood Pressure | CFB at 2 Hours | -7.9 mmHg | Standard Deviation 8.59 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Supine Diastolic Blood Pressure | CFB at 4 Hours | -6.4 mmHg | Standard Deviation 10.2 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Supine Diastolic Blood Pressure | CFB at 6 Hours | -4.6 mmHg | Standard Deviation 9.7 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Supine Diastolic Blood Pressure | CFB at 8 Hours | -8.8 mmHg | Standard Deviation 10.17 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Supine Diastolic Blood Pressure | CFB at 10 Hours | -2.4 mmHg | Standard Deviation 9.52 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Supine Diastolic Blood Pressure | CFB at 12 Hours | 0.3 mmHg | Standard Deviation 8.8 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Supine Diastolic Blood Pressure | CFB at 14 Hours | -2.2 mmHg | Standard Deviation 9.03 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Supine Diastolic Blood Pressure | CFB at 24 Hours | -0.3 mmHg | Standard Deviation 8.99 |
Primary
Stage 2: Change From Baseline in Vital Signs Parameter - Supine Heart Rate
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in supine heart rate is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Supine Heart Rate | Pre-infusion | 69.5 bpm | Standard Deviation 10.96 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Supine Heart Rate | CFB at 2 Hours | 0.7 bpm | Standard Deviation 10.18 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Supine Heart Rate | CFB at 4 Hours | -3.3 bpm | Standard Deviation 7.22 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Supine Heart Rate | CFB at 6 Hours | -3.3 bpm | Standard Deviation 10.3 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Supine Heart Rate | CFB at 8 Hours | -1.5 bpm | Standard Deviation 9 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Supine Heart Rate | CFB at 10 Hours | -1.5 bpm | Standard Deviation 9.1 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Supine Heart Rate | CFB at 12 Hours | -2.1 bpm | Standard Deviation 8.55 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Supine Heart Rate | CFB at 14 Hours | 3.9 bpm | Standard Deviation 10.29 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Supine Heart Rate | CFB at 24 Hours | 2.6 bpm | Standard Deviation 8.7 |
Primary
Stage 2: Change From Baseline in Vital Signs Parameter - Supine Systolic Blood Pressure
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in supine systolic blood pressure is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Supine Systolic Blood Pressure | Pre-infusion | 125.3 mmHg | Standard Deviation 13.22 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Supine Systolic Blood Pressure | CFB at 2 Hours | -12.1 mmHg | Standard Deviation 14.95 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Supine Systolic Blood Pressure | CFB at 4 Hours | -7.6 mmHg | Standard Deviation 17.12 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Supine Systolic Blood Pressure | CFB at 6 Hours | -7.9 mmHg | Standard Deviation 14.01 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Supine Systolic Blood Pressure | CFB at 8 Hours | -6.8 mmHg | Standard Deviation 17.44 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Supine Systolic Blood Pressure | CFB at 10 Hours | -2.9 mmHg | Standard Deviation 13.48 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Supine Systolic Blood Pressure | CFB at 12 Hours | 4.0 mmHg | Standard Deviation 13.22 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Supine Systolic Blood Pressure | CFB at 14 Hours | 3.1 mmHg | Standard Deviation 18.44 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Supine Systolic Blood Pressure | CFB at 24 Hours | 4.3 mmHg | Standard Deviation 11.12 |
Primary
Stage 2: Change From Baseline in Vital Signs Parameter - Temperature
Vital signs included supine systolic blood pressure, supine diastolic blood pressure, supine heart rate, standing systolic blood pressure, standing diastolic blood pressure, standing heart rate, temperature, and respiratory rate. CFB in temperature is reported in this outcome measure. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Stage 2 Day 1: Pre-infusion (Baseline) and 2, 4, 6, 8, 10, 12, 14 and 24 hours post-infusion
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Temperature | Pre-infusion | 36.64 degree Celsius | Standard Deviation 0.15 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Temperature | CFB at 2 Hours | -0.01 degree Celsius | Standard Deviation 0.25 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Temperature | CFB at 4 Hours | -0.06 degree Celsius | Standard Deviation 0.2 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Temperature | CFB at 6 Hours | 0.01 degree Celsius | Standard Deviation 0.18 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Temperature | CFB at 8 Hours | -0.02 degree Celsius | Standard Deviation 0.23 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Temperature | CFB at 10 Hours | 0.02 degree Celsius | Standard Deviation 0.2 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Temperature | CFB at 12 Hours | -0.01 degree Celsius | Standard Deviation 0.4 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Temperature | CFB at 14 Hours | 0.02 degree Celsius | Standard Deviation 0.21 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Vital Signs Parameter - Temperature | CFB at 24 Hours | -0.01 degree Celsius | Standard Deviation 0.29 |
Primary
Stage 2: Percentage of Participants With a Response of 'Yes' to Any Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation or Suicidal Behavior Item at Any Visit
The C-SSRS scale consisted of baseline evaluation that assessed lifetime experience of participants with SI and SB and postbaseline evaluation that focused on suicidality since last study visit. C-SSRS included yes or no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present \[from 1 (minor physical damage) to 5 (death), with 5 being most severe\]. C-SSRS SI items involved (a) wish to be dead, (b) non-specific active suicidal thoughts, (c) active SI with any methods (not plan) without intent to act, (d) active SI with some intent to act, without specific plan and (e) active SI with specific plan and intent. C-SSRS SB items involved (a) actual attempt, (b) engaged in non-suicidal self-injurious behavior, (c) interrupted attempt, (d) aborted attempt, (e) preparatory acts or behavior, (f) suicidal behavior.
Time frame: Stage 2 Day 1: Pre-infusion and 10 hours and 7-day follow-up post-infusion
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Percentage of Participants With a Response of 'Yes' to Any Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation or Suicidal Behavior Item at Any Visit | 0 percentage of participants |
Primary
Stage 2: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was defined as an AE with start date/time after the start of initial infusion in each stage. An SAE is defined as an AE or suspected adverse reaction, which in the view of either the Investigator or Sponsor, results in any of the following outcomes: death; is life-threatening; inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant disability or incapacity; congenital anomaly or birth defect or other medically important condition.
Time frame: Stage 2: Up to 30 days after last infusion (up to Day 31)
Population: Participants from safety population, which included all participants admitted into the inpatient unit who met all eligibility criteria, signed an informed consent, and who began infusion with SAGE-547 or placebo in Treatment Period 1, who received study drug in Stage 2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs | 47.1 percentage of participants |
| Stage 1: SAGE-547 | Stage 2: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 0 percentage of participants |
Secondary
Stage 1: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of SAGE-547
Time frame: Stage 1: Pre-infusion and after the start of infusion at 30 and 40 minutes and at 1, 1.5, 2, 4, 6, 8, 10, 12, 12.5, 12.75, 13, 13.5, 14, 16 and 24 hours
Population: PK population was defined as all safety population participants who completed at least 12 hours of SAGE-547 infusion in Treatment Period 1 or Treatment Period 2 of Stage 1 with sufficient plasma concentrations for PK evaluation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of SAGE-547 | 716 ng*h/mL | Standard Deviation 286 |
Secondary
Stage 1: Area Under the Plasma Concentration Time Curve up to the Time of the Last Quantifiable Sample (AUClast) of SAGE-547
Time frame: Stage 1: Pre-infusion and after the start of infusion at 30 and 40 minutes and at 1, 1.5, 2, 4, 6, 8, 10, 12, 12.5, 12.75, 13, 13.5, 14, 16 and 24 hours
Population: PK population was defined as all safety population participants who completed at least 12 hours of SAGE-547 infusion in Treatment Period 1 or Treatment Period 2 of Stage 1 with sufficient plasma concentrations for PK evaluation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Area Under the Plasma Concentration Time Curve up to the Time of the Last Quantifiable Sample (AUClast) of SAGE-547 | 654 nanograms*hours per milliliter (ng*h/mL) | Standard Deviation 251 |
Secondary
Stage 1: Change From Baseline in Accelerometer Total Score Response
Accelerometer total score response was defined as ≥30% decrease from baseline to each time point in accelerometer total score. Accelerometer total score is sum of forward outstretched postural tremor, lateral wing-beating postural tremor, and kinetic tremor scores across both sides of the body (i.e., right and left). Accelerometer was used for transducer measurement of tremor amplitude. Participants wore wireless ring motion sensor. It measured linear acceleration and angular velocity (i.e., kinesia score). Information from motion sensor data was correlated to symptoms of tremor. Kinesia (accelerometer) scores ranged from 0 to 4 in 0.5 step increments. The total score ranges from 0 to 24, higher scores indicating more severe tremors. Negative change from baseline indicated decrease in tremor. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Stage 1 Days 1 and 10: Pre-infusion (Baseline) and 2, 4, 6, 8, 10 and 12 hours and 12-hour follow-up post-infusion
Population: Efficacy population was defined as all participants in the safety population who completed ≥12 hours of infusion and had efficacy evaluations through the 12-hour visits in both Treatment Periods 1 and 2 of Stage 1. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Accelerometer Total Score Response | Pre-infusion | 7.13 score on a scale | Standard Deviation 3.902 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Accelerometer Total Score Response | CFB at 2 Hours | -0.96 score on a scale | Standard Deviation 1.373 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Accelerometer Total Score Response | CFB at 4 Hours | -0.83 score on a scale | Standard Deviation 1.876 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Accelerometer Total Score Response | CFB at 6 Hours | -1.25 score on a scale | Standard Deviation 1.943 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Accelerometer Total Score Response | CFB at 8 Hours | -0.93 score on a scale | Standard Deviation 1.903 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Accelerometer Total Score Response | CFB at 10 Hours | -1.24 score on a scale | Standard Deviation 1.814 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Accelerometer Total Score Response | CFB at 12 Hours | -1.39 score on a scale | Standard Deviation 1.436 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Accelerometer Total Score Response | CFB at 12-hour Follow-up | 0.05 score on a scale | Standard Deviation 1.498 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Accelerometer Total Score Response | CFB at 12-hour Follow-up | -0.21 score on a scale | Standard Deviation 1.927 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Accelerometer Total Score Response | Pre-infusion | 7.41 score on a scale | Standard Deviation 4.137 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Accelerometer Total Score Response | CFB at 8 Hours | -1.03 score on a scale | Standard Deviation 1.447 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Accelerometer Total Score Response | CFB at 2 Hours | -1.05 score on a scale | Standard Deviation 1.563 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Accelerometer Total Score Response | CFB at 12 Hours | -0.91 score on a scale | Standard Deviation 1.284 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Accelerometer Total Score Response | CFB at 4 Hours | -0.74 score on a scale | Standard Deviation 1.833 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Accelerometer Total Score Response | CFB at 10 Hours | -0.85 score on a scale | Standard Deviation 1.713 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Accelerometer Total Score Response | CFB at 6 Hours | -0.75 score on a scale | Standard Deviation 1.186 |
Secondary
Stage 1: Change From Baseline in Stanford Sleepiness Scale (SSS) Score
SSS is a participant-rated scale designed to quickly assess how alert a participant was feeling. Degrees of sleepiness and alertness were rated on a scale of 1 to 7, where the lowest score of '1' indicated the participant was 'feeling active, vital, alert, or wide awake' and the highest score of '7' indicated the participant was 'no longer fighting sleep, sleep onset soon; having dream-like thoughts'. Baseline is defined as the pre-infusion value in each period. A negative change from baseline indicated less sleepiness.
Time frame: Stage 1 Day 1 and 10: Pre-infusion (Baseline) and 2, 4, 6, 8, 10 and 12 hours and 12-hour follow-up post-infusion
Population: Efficacy population was defined as all participants in the safety population who completed ≥12 hours of infusion and had efficacy evaluations through the 12-hour visits in both Treatment Periods 1 and 2 of Stage 1. Overall number of participants analyzed = Number of participants analyzed in this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Stanford Sleepiness Scale (SSS) Score | Pre-infusion | 1.6 score on a scale | Standard Deviation 0.77 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Stanford Sleepiness Scale (SSS) Score | CFB at 2 Hours | 0.3 score on a scale | Standard Deviation 1.37 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Stanford Sleepiness Scale (SSS) Score | CFB at 4 Hours | 0.3 score on a scale | Standard Deviation 1.4 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Stanford Sleepiness Scale (SSS) Score | CFB at 6 Hours | 0.7 score on a scale | Standard Deviation 1.09 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Stanford Sleepiness Scale (SSS) Score | CFB at 8 Hours | 0.1 score on a scale | Standard Deviation 1.08 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Stanford Sleepiness Scale (SSS) Score | CFB at 10 Hours | 0.3 score on a scale | Standard Deviation 1.4 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Stanford Sleepiness Scale (SSS) Score | CFB at 12 Hours | 0.2 score on a scale | Standard Deviation 0.87 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in Stanford Sleepiness Scale (SSS) Score | CFB at 12-hour Follow-up | -0.1 score on a scale | Standard Deviation 0.54 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Stanford Sleepiness Scale (SSS) Score | CFB at 12-hour Follow-up | -0.2 score on a scale | Standard Deviation 0.75 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Stanford Sleepiness Scale (SSS) Score | Pre-infusion | 1.6 score on a scale | Standard Deviation 0.76 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Stanford Sleepiness Scale (SSS) Score | CFB at 8 Hours | 0.0 score on a scale | Standard Deviation 0.82 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Stanford Sleepiness Scale (SSS) Score | CFB at 2 Hours | 0.0 score on a scale | Standard Deviation 0.41 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Stanford Sleepiness Scale (SSS) Score | CFB at 12 Hours | -0.0 score on a scale | Standard Deviation 0.89 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Stanford Sleepiness Scale (SSS) Score | CFB at 4 Hours | 0.1 score on a scale | Standard Deviation 0.53 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Stanford Sleepiness Scale (SSS) Score | CFB at 10 Hours | 0.2 score on a scale | Standard Deviation 0.93 |
| Stage 1: Placebo | Stage 1: Change From Baseline in Stanford Sleepiness Scale (SSS) Score | CFB at 6 Hours | 0.1 score on a scale | Standard Deviation 0.83 |
Secondary
Stage 1: Change From Baseline in The Essential Tremor Rating Scale (TETRAS) Using Performance Subscale (PS) Part 4 Upper-Limb Total Scores
The TETRAS PS total score was calculated as the sum of items 4 (upper-limb), 6 (Archimedes spiral), 7 (handwriting), and 8 (dot approximation). TETRAS PS upper-limb total score was calculated as the sum of the 6 separate upper-limb maneuvers assessed by the clinician: forward-outstretched postural tremor \[right\], forward outstretched postural tremor \[left\], lateral wing-beating postural tremor \[right\], lateral wing-beating postural tremor \[left\], kinetic tremor \[right\], kinetic tremor \[left\], each on a 0 (no tremor) to 4 (maximum tremor) severity scale in 0.5-point increments. TETRAS Part 4 score for both upper limbs ranged from 0 to 24, higher scores indicated more severe tremor. A negative change from baseline indicated less tremor. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Stage 1 Days 1 and 10: Pre-infusion (Baseline) and 2, 4, 6, 8, 10 and 12 hours and 12-hour follow-up post-infusion
Population: Efficacy population was defined as all participants in the safety population who completed ≥12 hours of infusion and had efficacy evaluations through the 12-hour visits in both Treatment Periods 1 and 2 of Stage 1.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in The Essential Tremor Rating Scale (TETRAS) Using Performance Subscale (PS) Part 4 Upper-Limb Total Scores | Pre-infusion | 9.48 score on a scale | Standard Deviation 3.917 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in The Essential Tremor Rating Scale (TETRAS) Using Performance Subscale (PS) Part 4 Upper-Limb Total Scores | CFB at 2 Hours | -2.10 score on a scale | Standard Deviation 2.309 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in The Essential Tremor Rating Scale (TETRAS) Using Performance Subscale (PS) Part 4 Upper-Limb Total Scores | CFB at 4 Hours | -2.06 score on a scale | Standard Deviation 2.205 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in The Essential Tremor Rating Scale (TETRAS) Using Performance Subscale (PS) Part 4 Upper-Limb Total Scores | CFB at 6 Hours | -2.94 score on a scale | Standard Deviation 2.007 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in The Essential Tremor Rating Scale (TETRAS) Using Performance Subscale (PS) Part 4 Upper-Limb Total Scores | CFB at 8 Hours | -2.94 score on a scale | Standard Deviation 2.682 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in The Essential Tremor Rating Scale (TETRAS) Using Performance Subscale (PS) Part 4 Upper-Limb Total Scores | CFB at 10 Hours | -2.94 score on a scale | Standard Deviation 2.505 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in The Essential Tremor Rating Scale (TETRAS) Using Performance Subscale (PS) Part 4 Upper-Limb Total Scores | CFB at 12 Hours | -3.48 score on a scale | Standard Deviation 2.632 |
| Stage 1: SAGE-547 | Stage 1: Change From Baseline in The Essential Tremor Rating Scale (TETRAS) Using Performance Subscale (PS) Part 4 Upper-Limb Total Scores | CFB at 12-hour Follow-up | -1.38 score on a scale | Standard Deviation 1.943 |
| Stage 1: Placebo | Stage 1: Change From Baseline in The Essential Tremor Rating Scale (TETRAS) Using Performance Subscale (PS) Part 4 Upper-Limb Total Scores | CFB at 12-hour Follow-up | -1.70 score on a scale | Standard Deviation 1.507 |
| Stage 1: Placebo | Stage 1: Change From Baseline in The Essential Tremor Rating Scale (TETRAS) Using Performance Subscale (PS) Part 4 Upper-Limb Total Scores | Pre-infusion | 9.72 score on a scale | Standard Deviation 3.199 |
| Stage 1: Placebo | Stage 1: Change From Baseline in The Essential Tremor Rating Scale (TETRAS) Using Performance Subscale (PS) Part 4 Upper-Limb Total Scores | CFB at 8 Hours | -2.74 score on a scale | Standard Deviation 1.943 |
| Stage 1: Placebo | Stage 1: Change From Baseline in The Essential Tremor Rating Scale (TETRAS) Using Performance Subscale (PS) Part 4 Upper-Limb Total Scores | CFB at 2 Hours | -2.10 score on a scale | Standard Deviation 1.86 |
| Stage 1: Placebo | Stage 1: Change From Baseline in The Essential Tremor Rating Scale (TETRAS) Using Performance Subscale (PS) Part 4 Upper-Limb Total Scores | CFB at 12 Hours | -2.46 score on a scale | Standard Deviation 2.031 |
| Stage 1: Placebo | Stage 1: Change From Baseline in The Essential Tremor Rating Scale (TETRAS) Using Performance Subscale (PS) Part 4 Upper-Limb Total Scores | CFB at 4 Hours | -2.72 score on a scale | Standard Deviation 2.107 |
| Stage 1: Placebo | Stage 1: Change From Baseline in The Essential Tremor Rating Scale (TETRAS) Using Performance Subscale (PS) Part 4 Upper-Limb Total Scores | CFB at 10 Hours | -2.60 score on a scale | Standard Deviation 1.898 |
| Stage 1: Placebo | Stage 1: Change From Baseline in The Essential Tremor Rating Scale (TETRAS) Using Performance Subscale (PS) Part 4 Upper-Limb Total Scores | CFB at 6 Hours | -1.84 score on a scale | Standard Deviation 1.553 |
Secondary
Stage 1: Clearance (CL) of SAGE-547
Clearance is defined as the volume of plasma from which a substance is completely removed per unit time.
Time frame: Stage 1: Pre-infusion and after the start of infusion at 30 and 40 minutes and at 1, 1.5, 2, 4, 6, 8, 10, 12, 12.5, 12.75, 13, 13.5, 14, 16 and 24 hours
Population: PK population was defined as all safety population participants who completed at least 12 hours of SAGE-547 infusion in Treatment Period 1 or Treatment Period 2 of Stage 1 with sufficient plasma concentrations for PK evaluation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Clearance (CL) of SAGE-547 | 1.09 liters per hour per kilogram (L/h/kg) | Standard Deviation 0.41 |
Secondary
Stage 1: Maximum Peak Plasma Concentration (Cmax) of SAGE-547
Time frame: Stage 1: Pre-infusion and after the start of infusion at 30 and 40 minutes and at 1, 1.5, 2, 4, 6, 8, 10, 12, 12.5, 12.75, 13, 13.5, 14, 16 and 24 hours
Population: Pharmacokinetic (PK) population was defined as all safety population participants who completed at least 12 hours of SAGE-547 infusion in Treatment Period 1 or Treatment Period 2 of Stage 1 with sufficient plasma concentrations for PK evaluation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Maximum Peak Plasma Concentration (Cmax) of SAGE-547 | 84.3 nanograms per milliliter (ng/mL) | Standard Deviation 28.2 |
Secondary
Stage 1: Terminal Half-Life (t½) of SAGE-547
Terminal half-life is defined as the time required to divide the plasma concentration by two after reaching pseudo-equilibrium.
Time frame: Stage 1: Pre-infusion and after the start of infusion at 30 and 40 minutes and at 1, 1.5, 2, 4, 6, 8, 10, 12, 12.5, 12.75, 13, 13.5, 14, 16 and 24 hours
Population: PK population was defined as all safety population participants who completed at least 12 hours of SAGE-547 infusion in Treatment Period 1 or Treatment Period 2 of Stage 1 with sufficient plasma concentrations for PK evaluation.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Terminal Half-Life (t½) of SAGE-547 | 5.6 hours |
Secondary
Stage 1: Time to Maximum Peak Plasma Concentration (Cmax) of SAGE-547
Time frame: Stage 1: Pre-infusion and after the start of infusion at 30 and 40 minutes and at 1, 1.5, 2, 4, 6, 8, 10, 12, 12.5, 12.75, 13, 13.5, 14, 16 and 24 hours
Population: PK population was defined as all safety population participants who completed at least 12 hours of SAGE-547 infusion in Treatment Period 1 or Treatment Period 2 of Stage 1 with sufficient plasma concentrations for PK evaluation.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Stage 1: SAGE-547 | Stage 1: Time to Maximum Peak Plasma Concentration (Cmax) of SAGE-547 | 10 hours |
Secondary
Stage 2: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of SAGE-547
Time frame: Stage 2: Pre-infusion and at 30, 60, 90 and 120 minutes and at 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 10.5, 10.75, 11, 11.5, 12, 14, 16 and 24 hours after start of the infusion
Population: PK population was participants from safety population, who completed at least 12 hours of SAGE-547 infusion in Treatment Period 1 or Treatment Period 2 with sufficient plasma concentrations for PK evaluation, who received study drug in Stage 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of SAGE-547 | 1380 ng*h/mL | Standard Deviation 300 |
Secondary
Stage 2: Area Under the Plasma Concentration Time Curve up to the Time of the Last Quantifiable Sample (AUClast) of SAGE-547
Time frame: Day 1: Pre-infusion and at 30, 60, 90 and 120 minutes and at 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 10.5, 10.75, 11, 11.5, 12, 14, 16 and 24 hours after start of the infusion
Population: PK population was participants from safety population, who completed at least 12 hours of SAGE-547 infusion in Treatment Period 1 or Treatment Period 2 with sufficient plasma concentrations for PK evaluation, who received study drug in Stage 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Area Under the Plasma Concentration Time Curve up to the Time of the Last Quantifiable Sample (AUClast) of SAGE-547 | 1310 ng*h/mL | Standard Deviation 300 |
Secondary
Stage 2: Change From Baseline in Accelerometer Total Score Response
Accelerometer total score response was defined as ≥30% decrease from baseline to each time point in accelerometer total score. Accelerometer total score is sum of forward outstretched postural tremor, lateral wing beating postural tremor, and kinetic tremor scores across both sides of the body (i.e., right and left). Accelerometer was used for transducer measurement of tremor amplitude. Participants wore wireless ring motion sensor. It measured linear acceleration and angular velocity (i.e., kinesia score). Information from motion sensor data was correlated to symptoms of tremor. Kinesia (accelerometer) scores ranged from 0 to 4 in 0.5 step increments. The total score ranges from 0 to 24, higher scores indicating more severe tremors. Negative change from baseline indicated decrease in tremor. Baseline is defined as the pre-infusion value in each period/stage.
Time frame: Stage 2 Day 1: Baseline and 2, 3, 4, 6, 8, 10, 12, 14 and 24 hours
Population: Efficacy population was participants from safety population, who completed ≥12 hours of infusion and had efficacy evaluations through the 12-hour visits in both Treatment Periods 1 and 2, who received study drug in Stage 2. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Accelerometer Total Score Response | Baseline | 6.96 score on a scale | Standard Deviation 4.901 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Accelerometer Total Score Response | CFB at 2 Hours | -1.37 score on a scale | Standard Deviation 2.202 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Accelerometer Total Score Response | CFB at 3 Hours | -1.25 score on a scale | Standard Deviation 1.89 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Accelerometer Total Score Response | CFB at 4 Hours | -1.57 score on a scale | Standard Deviation 2.186 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Accelerometer Total Score Response | CFB at 6 Hours | -1.44 score on a scale | Standard Deviation 2.553 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Accelerometer Total Score Response | CFB at 8 Hours | -2.06 score on a scale | Standard Deviation 2.942 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Accelerometer Total Score Response | CFB at 10 Hours | -1.16 score on a scale | Standard Deviation 1.809 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Accelerometer Total Score Response | CFB at 12 Hours | -0.89 score on a scale | Standard Deviation 1.845 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Accelerometer Total Score Response | CFB at 14 Hours | -0.35 score on a scale | Standard Deviation 1.78 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Accelerometer Total Score Response | CFB at 24 Hours | 0.18 score on a scale | Standard Deviation 2.033 |
Secondary
Stage 2: Change From Baseline in Stanford Sleepiness Scale (SSS) Score
SSS is a participant-rated scale designed to quickly assess how alert a participant was feeling. Degrees of sleepiness and alertness were rated on a scale of 1 to 7, where the lowest score of '1' indicated the participant was 'feeling active, vital, alert, or wide awake' and the highest score of '7' indicated the participant was 'no longer fighting sleep, sleep onset soon; having dream-like thoughts'. Baseline is defined as the pre-infusion value in each period. A negative change from baseline indicated less sleepiness.
Time frame: Stage 2 Day 1: Baseline and at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours
Population: Efficacy population was participants from safety population who completed ≥12 hours of infusion and had efficacy evaluations through the 12-hour visits in both Treatment Periods 1 and 2, who received study drug in Stage 2. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Stanford Sleepiness Scale (SSS) Score | CFB at 4 Hours | 3.1 score on a scale | Standard Deviation 1.81 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Stanford Sleepiness Scale (SSS) Score | Baseline | 1.5 score on a scale | Standard Deviation 0.62 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Stanford Sleepiness Scale (SSS) Score | CFB at 1 Hour | 0.4 score on a scale | Standard Deviation 1.12 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Stanford Sleepiness Scale (SSS) Score | CFB at 2 Hours | 1.4 score on a scale | Standard Deviation 1.09 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Stanford Sleepiness Scale (SSS) Score | CFB at 3 Hours | 2.5 score on a scale | Standard Deviation 2.1 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Stanford Sleepiness Scale (SSS) Score | CFB at 5 Hours | 3.3 score on a scale | Standard Deviation 2.02 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Stanford Sleepiness Scale (SSS) Score | CFB at 6 Hours | 3.3 score on a scale | Standard Deviation 1.91 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Stanford Sleepiness Scale (SSS) Score | CFB at 7 Hours | 2.6 score on a scale | Standard Deviation 1.79 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Stanford Sleepiness Scale (SSS) Score | CFB at 8 Hours | 2.4 score on a scale | Standard Deviation 1.86 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Stanford Sleepiness Scale (SSS) Score | CFB at 9 Hours | 2.3 score on a scale | Standard Deviation 1.91 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Stanford Sleepiness Scale (SSS) Score | CFB at 10 Hours | 2.0 score on a scale | Standard Deviation 1.97 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Stanford Sleepiness Scale (SSS) Score | CFB at 11 Hours | 0.1 score on a scale | Standard Deviation 0.85 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Stanford Sleepiness Scale (SSS) Score | CFB at 12 Hours | -0.3 score on a scale | Standard Deviation 0.86 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Stanford Sleepiness Scale (SSS) Score | CFB at 14 Hours | 0.3 score on a scale | Standard Deviation 1.44 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in Stanford Sleepiness Scale (SSS) Score | CFB at 24 Hours | -0.3 score on a scale | Standard Deviation 0.86 |
Secondary
Stage 2: Change From Baseline in TETRAS Using PS Part 4 Upper-Limb Total Scores
The TETRAS PS total score was calculated as the sum of items 4 (upper-limb), 6 (Archimedes spiral), 7 (handwriting), and 8 (dot approximation). TETRAS PS upper-limb total score was calculated as the sum of the 6 separate upper-limb maneuvers assessed by the clinician: forward-outstretched postural tremor \[right\], forward outstretched postural tremor \[left\], lateral wing-beating postural tremor \[right\], lateral wing-beating postural tremor \[left\], kinetic tremor \[right\], kinetic tremor \[left\], each on a 0 (no tremor) to 4 (maximum tremor) severity scale in 0.5-point increments. TETRAS Part 4 score for both upper limbs ranged from 0 to 24, higher scores indicated more severe tremor. A negative change from baseline indicated less tremor.
Time frame: Stage 2 Day 1: Baseline and at 2, 3, 4, 6, 8, 10, 12, 14 and 24 hours
Population: Efficacy population was participants from safety population, who completed ≥12 hours of infusion and had efficacy evaluations through the 12-hour visits in both Treatment Periods 1 and 2, who received study drug in Stage 2. Number analyzed = Number of participants with data available at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in TETRAS Using PS Part 4 Upper-Limb Total Scores | Baseline | 9.24 score on a scale | Standard Deviation 1.977 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in TETRAS Using PS Part 4 Upper-Limb Total Scores | CFB at 2 Hours | -1.66 score on a scale | Standard Deviation 2.173 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in TETRAS Using PS Part 4 Upper-Limb Total Scores | CFB at 3 Hours | -2.44 score on a scale | Standard Deviation 2.542 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in TETRAS Using PS Part 4 Upper-Limb Total Scores | CFB at 4 Hours | -3.25 score on a scale | Standard Deviation 2.55 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in TETRAS Using PS Part 4 Upper-Limb Total Scores | CFB at 6 Hours | -2.66 score on a scale | Standard Deviation 2.612 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in TETRAS Using PS Part 4 Upper-Limb Total Scores | CFB at 8 Hours | -3.16 score on a scale | Standard Deviation 2.809 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in TETRAS Using PS Part 4 Upper-Limb Total Scores | CFB at 10 Hours | -2.19 score on a scale | Standard Deviation 1.642 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in TETRAS Using PS Part 4 Upper-Limb Total Scores | CFB at 12 Hours | -1.25 score on a scale | Standard Deviation 1.602 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in TETRAS Using PS Part 4 Upper-Limb Total Scores | CFB at 14 Hours | -0.66 score on a scale | Standard Deviation 1.091 |
| Stage 1: SAGE-547 | Stage 2: Change From Baseline in TETRAS Using PS Part 4 Upper-Limb Total Scores | CFB at 24 Hours | -0.84 score on a scale | Standard Deviation 1.85 |
Secondary
Stage 2: Clearance (CL) of SAGE-547
Clearance is defined as the volume of plasma from which a substance is completely removed per unit time.
Time frame: Stage 2: Pre-infusion and at 30, 60, 90 and 120 minutes and at 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 10.5, 10.75, 11, 11.5, 12, 14, 16 and 24 hours after start of the infusion
Population: PK population was participants from safety population, who completed at least 12 hours of SAGE-547 infusion in Treatment Period 1 or Treatment Period 2 with sufficient plasma concentrations for PK evaluation, who received study drug in Stage 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Clearance (CL) of SAGE-547 | 1.07 L/h/kg | Standard Deviation 0.28 |
Secondary
Stage 2: Maximum Peak Plasma Concentration (Cmax) of SAGE-547
Time frame: Stage 2: Pre-infusion and at 30, 60, 90 and 120 minutes and at 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 10.5, 10.75, 11, 11.5, 12, 14, 16 and 24 hours after start of the infusion
Population: PK population was participants from safety population, who completed at least 12 hours of SAGE-547 infusion in Treatment Period 1 or Treatment Period 2 with sufficient plasma concentrations for PK evaluation, who received study drug in Stage 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Maximum Peak Plasma Concentration (Cmax) of SAGE-547 | 152 ng/mL | Standard Deviation 36 |
Secondary
Stage 2: Terminal Half-Life (t½) of SAGE-547
Terminal half-life is defined as the time required to divide the plasma concentration by two after reaching pseudo-equilibrium.
Time frame: Stage 2: Pre-infusion and at 30, 60, 90 and 120 minutes and at 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 10.5, 10.75, 11, 11.5, 12, 14, 16 and 24 hours after start of the infusion
Population: PK population was defined as all safety population participants who completed at least 12 hours of SAGE-547 infusion in Treatment Period 1 or Treatment Period 2 of Stage 1 with sufficient plasma concentrations for PK evaluation.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Terminal Half-Life (t½) of SAGE-547 | 7.6 hours |
Secondary
Stage 2: Time to Maximum Peak Plasma Concentration (Cmax) of SAGE-547
Time frame: Stage 2: Pre-infusion and at 30, 60, 90 and 120 minutes and at 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 10.5, 10.75, 11, 11.5, 12, 14, 16 and 24 hours after start of the infusion
Population: PK population was participants from safety population, who completed at least 12 hours of SAGE-547 infusion in Treatment Period 1 or Treatment Period 2 with sufficient plasma concentrations for PK evaluation, who received study drug in Stage 2.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Stage 1: SAGE-547 | Stage 2: Time to Maximum Peak Plasma Concentration (Cmax) of SAGE-547 | 6 hours |