| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE with onset on or after the start of study drug infusion, or any worsening of a pre-existing medical condition/AE with onset on or after the start of study drug infusion. | The safety set included all participants administered study drug. | Posted | | Count of Participants | | Participants | | From first dose of study drug up to end of follow-up period (up to Day 30) | | | | ID | Title | Description |
|---|
| OG000 | Double-Blind Phase: Placebo | Participants received a 60-hour single continuous IV infusion of brexanolone-matching placebo, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study. | | OG001 | Double-Blind Phase: Brexanolone | Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study. | | OG002 | Open-Label Phase: Brexanolone | Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during open-label phase of the study. |
| | | Title | Denominators | Categories |
|---|
| | |
| |
| Secondary | Area Under the Concentration-Time Curve (AUC) From Time Zero to 60 Hours (AUC0-60) | | The pharmacokinetic (PK) set included participants in the safety set for whom at least one evaluable post-baseline PK sample with a measurable brexanolone concentration was available. | Posted | | Mean | Standard Deviation | hours*nanograms per milliliter(hr*ng/mL) | | Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion) | | | | ID | Title | Description |
|---|
| OG000 | Double-Blind Phase: Brexanolone | Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study. | | OG001 | Open-Label Phase: Brexanolone | Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during open-label phase of the study. |
| |
| Secondary | AUC From Time Zero to Infinity (AUCinf) | | The PK set included participants in the safety set for whom at least one evaluable post-baseline PK sample with a measurable brexanolone concentration was available. | Posted | | Mean | Standard Deviation | hr*ng/mL | | Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion) | | | | ID | Title | Description |
|---|
| OG000 | Double-Blind Phase: Brexanolone | Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study. | | OG001 | Open-Label Phase: Brexanolone | Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during open-label phase of the study. |
| |
| Secondary | Maximum (Peak) Plasma Concentration (Cmax) | | The PK set included participants in the safety set for whom at least one evaluable post-baseline PK sample with a measurable brexanolone concentration was available. | Posted | | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | | Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion) | | | | ID | Title | Description |
|---|
| OG000 | Double-Blind Phase: Brexanolone | Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study. | | OG001 | Open-Label Phase: Brexanolone | Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during open-label phase of the study. |
| |
| Secondary | Time at Maximum (Peak) Plasma Concentration (Tmax) | | The PK set included participants in the safety set for whom at least one evaluable post-baseline PK sample with a measurable brexanolone concentration was available. | Posted | | Median | Full Range | hour (hr) | | Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion) | | | | ID | Title | Description |
|---|
| OG000 | Double-Blind Phase: Brexanolone | Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study. | | OG001 | Open-Label Phase: Brexanolone | Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during open-label phase of the study. |
| |
| Secondary | Steady-State Drug Concentration in the Plasma During Constant-Rate Infusion (Css) | Given that brexanolone is infused to steady-state plasma concentrations, the model-predicted steady-state drug concentration in the plasma during constant-rate infusion value also represents the predicted maximum plasma concentration at the highest infused dose (90 ug/kg/h). | The PK set included participants in the safety set for whom at least one evaluable post-baseline PK sample with a measurable brexanolone concentration was available. | Posted | | Number | | ng/mL | | Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion) | | | | ID | Title | Description |
|---|
| OG000 | Double-Blind Phase: Brexanolone | Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study. | | OG001 | Open-Label Phase: Brexanolone | Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during open-label phase of the study. |
|
| Secondary | Average Drug Concentration in Plasma at Steady State During a Dosing Interval (Cavg) | Cavg was evaluated as the time-weighted average plasma concentrations of brexanolone over the interval. | The PK set included participants in the safety set for whom at least one evaluable post-baseline PK sample with a measurable brexanolone concentration was available. | Posted | | Mean | Standard Deviation | ng/mL | | Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion) | | | | ID | Title | Description |
|---|
| OG000 | Double-Blind Phase: Brexanolone | Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study. | | OG001 | Open-Label Phase: Brexanolone | Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during open-label phase of the study. |
| |
| Secondary | Half-Life of First Elimination Phase of Brexanolone (Thalf) | Half-life is the time required for half of the drug to be eliminated from the serum. | The PK set included participants in the safety set for whom at least one evaluable post-baseline PK sample with a measurable brexanolone concentration was available. | Posted | | Mean | Standard Deviation | hour | | Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion) | | | | ID | Title | Description |
|---|
| OG000 | Double-Blind Phase: Brexanolone | Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study. | | OG001 | Open-Label Phase: Brexanolone | Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during open-label phase of the study. |
| |
| Secondary | Clearance of Brexanolone (CL/F) | Clearance is defined as the volume of plasma from which a substance is completely removed per unit time. | The PK set included participants in the safety set for whom at least one evaluable post-baseline PK sample with a measurable brexanolone concentration was available. | Posted | | Mean | Standard Deviation | liters per hour (L/hr) | | Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion) | | | | ID | Title | Description |
|---|
| OG000 | Double-Blind Phase: Brexanolone | Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study. | | OG001 | Open-Label Phase: Brexanolone | Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during open-label phase of the study. |
| |
| Secondary | Steady-State of Volume of Distribution (Vss) | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. | The PK set included participants in the safety set for whom at least one evaluable post-baseline PK sample with a measurable brexanolone concentration was available. | Posted | | Mean | Standard Deviation | liters (L) | | Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion) | | | | ID | Title | Description |
|---|
| OG000 | Double-Blind Phase: Brexanolone | Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study. | | OG001 | Open-Label Phase: Brexanolone | Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during open-label phase of the study. |
| |