Trial Outcomes & Findings for Pharmacokinetic Study for IV Allopregnanolone (NCT NCT04468360)
NCT ID: NCT04468360
Last Updated: 2026-06-02
Results Overview
Sedation levels will be assessed with the Qualitative Sedation Rating Scale. It has 5 categories: None- responds normally to verbal commands, cognitive \& coordination not impaired, ventilatory \& cardiovascular functions unaffected; Minimal- responds normally to verbal commands, unaffected ventilatory \& cardiovascular functions, mild feelings of intoxication, cognitive function \& coordination may be impaired; Moderate-responds purposefully to commands alone or with light touch, protective airway reflexes \& adequate ventilation maintained without intervention, cardiovascular function remains stable; Deep- cannot be easily aroused but responds purposefully to noxious stimulation, assistance may be needed to ensure the airway is protected \& adequate ventilation maintained, cardiovascular function is usually stable; Dissociative- trance-like cataleptic state with profound analgesia \& amnesia, airway protective reflexes, spontaneous respirations \& cardiopulmonary stability retained.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
resting pre-infusion; after loading dose at 0 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes, and 300 minutes
Results posted on
2026-06-02
Participant Flow
Participant milestones
| Measure |
PK-1 Group
Participants assigned to this group received IV allopregnanolone as a 5-minute loading dose at 1.7 mcg/kg followed by a maintenance infusion at 2.6 mcg/kg/hr over the next 4-5 hours intended to optimize resting plasma allopregnanolone + pregnanolone levels while outcomes were measured.
|
PK-2 Group
Participants assigned to this group received a 30-minute drug infusion of IV allopregnanolone at a dose of 28 mcg/kg. The IV allopregnanolone then was discontinued and only normal saline was continued for the next 4-5 hours while outcomes were measured.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
|
Overall Study
COMPLETED
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetic Study for IV Allopregnanolone
Baseline characteristics by cohort
| Measure |
PK-1 Group
n=6 Participants
Participants assigned to this group received IV allopregnanolone as a 5-minute loading dose at 1.7 mcg/kg followed by a maintenance infusion at 2.6 mcg/kg/hr over the next 4-5 hours intended to optimize resting plasma allopregnanolone + pregnanolone levels while outcomes were measured.
|
PK-2 Group
n=5 Participants
Participants assigned to this group received a 30-minute drug infusion of IV allopregnanolone at a dose of 28 mcg/kg. The IV allopregnanolone then was discontinued and only normal saline was continued for the next 4-5 hours while outcomes were measured.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
2 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
11 Participants
n=267 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
11 Participants
n=267 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
7 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
7 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=9 Participants
|
5 participants
n=27 Participants
|
11 participants
n=267 Participants
|
PRIMARY outcome
Timeframe: resting pre-infusion; after loading dose at 0 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes, and 300 minutesSedation levels will be assessed with the Qualitative Sedation Rating Scale. It has 5 categories: None- responds normally to verbal commands, cognitive \& coordination not impaired, ventilatory \& cardiovascular functions unaffected; Minimal- responds normally to verbal commands, unaffected ventilatory \& cardiovascular functions, mild feelings of intoxication, cognitive function \& coordination may be impaired; Moderate-responds purposefully to commands alone or with light touch, protective airway reflexes \& adequate ventilation maintained without intervention, cardiovascular function remains stable; Deep- cannot be easily aroused but responds purposefully to noxious stimulation, assistance may be needed to ensure the airway is protected \& adequate ventilation maintained, cardiovascular function is usually stable; Dissociative- trance-like cataleptic state with profound analgesia \& amnesia, airway protective reflexes, spontaneous respirations \& cardiopulmonary stability retained.
Outcome measures
| Measure |
PK-1 Group
n=6 Participants
Participants assigned to this group received IV allopregnanolone as a 5-minute loading dose at 1.7 mcg/kg followed by a maintenance infusion at 2.6 mcg/kg/hr over the next 4-5 hours intended to optimize resting plasma allopregnanolone + pregnanolone levels while outcomes were measured.
|
PK-2 Group
n=5 Participants
Participants assigned to this group received a 30-minute drug infusion of IV allopregnanolone at a dose of 28 mcg/kg. The IV allopregnanolone then was discontinued and only normal saline was continued for the next 4-5 hours while outcomes were measured.
|
|---|---|---|
|
Clinician Assessed Sedation Levels for Each Participant
Pre-infusion : None
|
6 Participants
|
5 Participants
|
|
Clinician Assessed Sedation Levels for Each Participant
Pre-infusion : Minimal
|
0 Participants
|
0 Participants
|
|
Clinician Assessed Sedation Levels for Each Participant
Pre-infusion : Moderate
|
0 Participants
|
0 Participants
|
|
Clinician Assessed Sedation Levels for Each Participant
Pre-infusion : Deep
|
0 Participants
|
0 Participants
|
|
Clinician Assessed Sedation Levels for Each Participant
Pre-infusion : Dissociative
|
0 Participants
|
0 Participants
|
|
Clinician Assessed Sedation Levels for Each Participant
0 minutes after loading dose: None
|
6 Participants
|
5 Participants
|
|
Clinician Assessed Sedation Levels for Each Participant
0 minutes after loading dose: Minimal
|
0 Participants
|
0 Participants
|
|
Clinician Assessed Sedation Levels for Each Participant
0 minutes after loading dose: Moderate
|
0 Participants
|
0 Participants
|
|
Clinician Assessed Sedation Levels for Each Participant
0 minutes after loading dose: Deep
|
0 Participants
|
0 Participants
|
|
Clinician Assessed Sedation Levels for Each Participant
0 minutes after loading dose: Dissociative
|
0 Participants
|
0 Participants
|
|
Clinician Assessed Sedation Levels for Each Participant
15 minutes after loading dose: None
|
6 Participants
|
5 Participants
|
|
Clinician Assessed Sedation Levels for Each Participant
15 minutes after loading dose: Minimal
|
0 Participants
|
0 Participants
|
|
Clinician Assessed Sedation Levels for Each Participant
15 minutes after loading dose: Moderate
|
0 Participants
|
0 Participants
|
|
Clinician Assessed Sedation Levels for Each Participant
15 minutes after loading dose: Deep
|
0 Participants
|
0 Participants
|
|
Clinician Assessed Sedation Levels for Each Participant
15 minutes after loading dose: Dissociative
|
0 Participants
|
0 Participants
|
|
Clinician Assessed Sedation Levels for Each Participant
30 minutes after loading dose: None
|
6 Participants
|
5 Participants
|
|
Clinician Assessed Sedation Levels for Each Participant
30 minutes after loading dose: Minimal
|
0 Participants
|
0 Participants
|
|
Clinician Assessed Sedation Levels for Each Participant
30 minutes after loading dose: Moderate
|
0 Participants
|
0 Participants
|
|
Clinician Assessed Sedation Levels for Each Participant
30 minutes after loading dose: Deep
|
0 Participants
|
0 Participants
|
|
Clinician Assessed Sedation Levels for Each Participant
30 minutes after loading dose: Dissociative
|
0 Participants
|
0 Participants
|
|
Clinician Assessed Sedation Levels for Each Participant
60 minutes after loading dose: None
|
6 Participants
|
5 Participants
|
|
Clinician Assessed Sedation Levels for Each Participant
60 minutes after loading dose: Minimal
|
0 Participants
|
0 Participants
|
|
Clinician Assessed Sedation Levels for Each Participant
60 minutes after loading dose: Moderate
|
0 Participants
|
0 Participants
|
|
Clinician Assessed Sedation Levels for Each Participant
60 minutes after loading dose: Deep
|
0 Participants
|
0 Participants
|
|
Clinician Assessed Sedation Levels for Each Participant
60 minutes after loading dose: Dissociative
|
0 Participants
|
0 Participants
|
|
Clinician Assessed Sedation Levels for Each Participant
120 minutes after loading dose: None
|
6 Participants
|
5 Participants
|
|
Clinician Assessed Sedation Levels for Each Participant
120 minutes after loading dose: Minimal
|
0 Participants
|
0 Participants
|
|
Clinician Assessed Sedation Levels for Each Participant
120 minutes after loading dose: Moderate
|
0 Participants
|
0 Participants
|
|
Clinician Assessed Sedation Levels for Each Participant
120 minutes after loading dose: Deep
|
0 Participants
|
0 Participants
|
|
Clinician Assessed Sedation Levels for Each Participant
120 minutes after loading dose: Dissociative
|
0 Participants
|
0 Participants
|
|
Clinician Assessed Sedation Levels for Each Participant
300 minutes after loading dose: None
|
6 Participants
|
5 Participants
|
|
Clinician Assessed Sedation Levels for Each Participant
300 minutes after loading dose: Minimal
|
0 Participants
|
0 Participants
|
|
Clinician Assessed Sedation Levels for Each Participant
300 minutes after loading dose: Moderate
|
0 Participants
|
0 Participants
|
|
Clinician Assessed Sedation Levels for Each Participant
300 minutes after loading dose: Deep
|
0 Participants
|
0 Participants
|
|
Clinician Assessed Sedation Levels for Each Participant
300 minutes after loading dose: Dissociative
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: resting pre-infusion; after loading dose at 0 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes, and 300 minutesAverage across participants of blood oxygen saturation levels obtained via pulse oximetry (ranging from 0% to 100%) for each time point indicated.
Outcome measures
| Measure |
PK-1 Group
n=6 Participants
Participants assigned to this group received IV allopregnanolone as a 5-minute loading dose at 1.7 mcg/kg followed by a maintenance infusion at 2.6 mcg/kg/hr over the next 4-5 hours intended to optimize resting plasma allopregnanolone + pregnanolone levels while outcomes were measured.
|
PK-2 Group
n=5 Participants
Participants assigned to this group received a 30-minute drug infusion of IV allopregnanolone at a dose of 28 mcg/kg. The IV allopregnanolone then was discontinued and only normal saline was continued for the next 4-5 hours while outcomes were measured.
|
|---|---|---|
|
Blood Oxygen Saturation
30 minutes after loading dose
|
98.3 percent oxygen saturation
Standard Deviation 1.2
|
98.4 percent oxygen saturation
Standard Deviation 1.7
|
|
Blood Oxygen Saturation
60 minutes after loading dose
|
98.5 percent oxygen saturation
Standard Deviation 1.5
|
98.4 percent oxygen saturation
Standard Deviation 1.1
|
|
Blood Oxygen Saturation
120 minutes after loading dose
|
98.5 percent oxygen saturation
Standard Deviation 0.8
|
98.8 percent oxygen saturation
Standard Deviation 1.8
|
|
Blood Oxygen Saturation
300 minutes after loading dose
|
98.2 percent oxygen saturation
Standard Deviation 1.3
|
98.6 percent oxygen saturation
Standard Deviation 1.1
|
|
Blood Oxygen Saturation
Pre-infusion
|
98.3 percent oxygen saturation
Standard Deviation 1.4
|
98.6 percent oxygen saturation
Standard Deviation 1.3
|
|
Blood Oxygen Saturation
0 minutes after loading dose
|
98.7 percent oxygen saturation
Standard Deviation 1.0
|
98.6 percent oxygen saturation
Standard Deviation 1.7
|
|
Blood Oxygen Saturation
15 minutes after loading dose
|
98.5 percent oxygen saturation
Standard Deviation 1.5
|
99 percent oxygen saturation
Standard Deviation 0.2
|
PRIMARY outcome
Timeframe: resting pre-infusion; after loading dose at 0 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes, and 300 minutesAverage across participants of respiratory rate for each time point indicated.
Outcome measures
| Measure |
PK-1 Group
n=6 Participants
Participants assigned to this group received IV allopregnanolone as a 5-minute loading dose at 1.7 mcg/kg followed by a maintenance infusion at 2.6 mcg/kg/hr over the next 4-5 hours intended to optimize resting plasma allopregnanolone + pregnanolone levels while outcomes were measured.
|
PK-2 Group
n=5 Participants
Participants assigned to this group received a 30-minute drug infusion of IV allopregnanolone at a dose of 28 mcg/kg. The IV allopregnanolone then was discontinued and only normal saline was continued for the next 4-5 hours while outcomes were measured.
|
|---|---|---|
|
Respiratory Rate
Pre-infusion
|
14.8 respirations per minute
Standard Deviation 3.0
|
14.2 respirations per minute
Standard Deviation 2.7
|
|
Respiratory Rate
0 minutes after loading dose
|
15.5 respirations per minute
Standard Deviation 2.8
|
15.2 respirations per minute
Standard Deviation 3.0
|
|
Respiratory Rate
15 minutes after loading dose
|
17.3 respirations per minute
Standard Deviation 4.1
|
16.4 respirations per minute
Standard Deviation 0.5
|
|
Respiratory Rate
30 minutes after loading dose
|
15.3 respirations per minute
Standard Deviation 2.7
|
16.4 respirations per minute
Standard Deviation 3.3
|
|
Respiratory Rate
60 minutes after loading dose
|
16.0 respirations per minute
Standard Deviation 2.8
|
14.8 respirations per minute
Standard Deviation 2.7
|
|
Respiratory Rate
120 minutes after loading dose
|
15.7 respirations per minute
Standard Deviation 2.7
|
14.8 respirations per minute
Standard Deviation 2.7
|
|
Respiratory Rate
300 minutes after loading dose
|
17.2 respirations per minute
Standard Deviation 2.7
|
14.4 respirations per minute
Standard Deviation 1.7
|
PRIMARY outcome
Timeframe: resting pre-infusion; after loading dose at 0 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes, and 300 minutesAverage across participants of pulse rate for each time point indicated.
Outcome measures
| Measure |
PK-1 Group
n=6 Participants
Participants assigned to this group received IV allopregnanolone as a 5-minute loading dose at 1.7 mcg/kg followed by a maintenance infusion at 2.6 mcg/kg/hr over the next 4-5 hours intended to optimize resting plasma allopregnanolone + pregnanolone levels while outcomes were measured.
|
PK-2 Group
n=5 Participants
Participants assigned to this group received a 30-minute drug infusion of IV allopregnanolone at a dose of 28 mcg/kg. The IV allopregnanolone then was discontinued and only normal saline was continued for the next 4-5 hours while outcomes were measured.
|
|---|---|---|
|
Pulse Rate
60 minutes after loading dose
|
70.2 number of heart beats/minute
Standard Deviation 6.9
|
68.6 number of heart beats/minute
Standard Deviation 6.6
|
|
Pulse Rate
120 minutes after loading dose
|
72.7 number of heart beats/minute
Standard Deviation 6.5
|
70.4 number of heart beats/minute
Standard Deviation 5.0
|
|
Pulse Rate
300 minutes after loading dose
|
76.8 number of heart beats/minute
Standard Deviation 8.4
|
76.0 number of heart beats/minute
Standard Deviation 4.8
|
|
Pulse Rate
Pre-infusion
|
71.7 number of heart beats/minute
Standard Deviation 9.4
|
68.8 number of heart beats/minute
Standard Deviation 5.1
|
|
Pulse Rate
0 minutes after loading dose
|
70.2 number of heart beats/minute
Standard Deviation 8.3
|
66.2 number of heart beats/minute
Standard Deviation 7.6
|
|
Pulse Rate
15 minutes after loading dose
|
75.7 number of heart beats/minute
Standard Deviation 12.9
|
65.8 number of heart beats/minute
Standard Deviation 1.3
|
|
Pulse Rate
30 minutes after loading dose
|
72.2 number of heart beats/minute
Standard Deviation 6.2
|
67.8 number of heart beats/minute
Standard Deviation 6.5
|
PRIMARY outcome
Timeframe: resting pre-infusion; after loading dose at 0 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes, and 300 minutesAverage across participants of diastolic blood pressure for each time point indicated.
Outcome measures
| Measure |
PK-1 Group
n=6 Participants
Participants assigned to this group received IV allopregnanolone as a 5-minute loading dose at 1.7 mcg/kg followed by a maintenance infusion at 2.6 mcg/kg/hr over the next 4-5 hours intended to optimize resting plasma allopregnanolone + pregnanolone levels while outcomes were measured.
|
PK-2 Group
n=5 Participants
Participants assigned to this group received a 30-minute drug infusion of IV allopregnanolone at a dose of 28 mcg/kg. The IV allopregnanolone then was discontinued and only normal saline was continued for the next 4-5 hours while outcomes were measured.
|
|---|---|---|
|
Diastolic Blood Pressure
Pre-infusion
|
79.0 mm Hg
Standard Deviation 7.4
|
74.0 mm Hg
Standard Deviation 11.3
|
|
Diastolic Blood Pressure
0 minutes after loading dose
|
73.7 mm Hg
Standard Deviation 9.2
|
70.6 mm Hg
Standard Deviation 8.2
|
|
Diastolic Blood Pressure
15 minutes after loading dose
|
78.8 mm Hg
Standard Deviation 9.3
|
74.8 mm Hg
Standard Deviation 2.4
|
|
Diastolic Blood Pressure
30 minutes after loading dose
|
77.8 mm Hg
Standard Deviation 9.1
|
71.8 mm Hg
Standard Deviation 11.7
|
|
Diastolic Blood Pressure
60 minutes after loading dose
|
76.5 mm Hg
Standard Deviation 8.1
|
68.6 mm Hg
Standard Deviation 2.8
|
|
Diastolic Blood Pressure
120 minutes after loading dose
|
78.5 mm Hg
Standard Deviation 11.2
|
72.8 mm Hg
Standard Deviation 6.6
|
|
Diastolic Blood Pressure
300 minutes after loading dose
|
74.8 mm Hg
Standard Deviation 5.7
|
68.6 mm Hg
Standard Deviation 4.9
|
PRIMARY outcome
Timeframe: resting pre-infusion; after loading dose at 0 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes, and 300 minutesAverage across participants of systolic blood pressure for each time point indicated.
Outcome measures
| Measure |
PK-1 Group
n=6 Participants
Participants assigned to this group received IV allopregnanolone as a 5-minute loading dose at 1.7 mcg/kg followed by a maintenance infusion at 2.6 mcg/kg/hr over the next 4-5 hours intended to optimize resting plasma allopregnanolone + pregnanolone levels while outcomes were measured.
|
PK-2 Group
n=5 Participants
Participants assigned to this group received a 30-minute drug infusion of IV allopregnanolone at a dose of 28 mcg/kg. The IV allopregnanolone then was discontinued and only normal saline was continued for the next 4-5 hours while outcomes were measured.
|
|---|---|---|
|
Systolic Blood Pressure
Pre-infusion
|
123.7 mmHg
Standard Deviation 14.5
|
110.0 mmHg
Standard Deviation 13.3
|
|
Systolic Blood Pressure
0 minutes after loading dose
|
113.7 mmHg
Standard Deviation 14.7
|
107.4 mmHg
Standard Deviation 9.4
|
|
Systolic Blood Pressure
15 minutes after loading dose
|
120.0 mmHg
Standard Deviation 11.1
|
114.0 mmHg
Standard Deviation 2.4
|
|
Systolic Blood Pressure
30 minutes after loading dose
|
119.2 mmHg
Standard Deviation 16.1
|
110.0 mmHg
Standard Deviation 11.4
|
|
Systolic Blood Pressure
60 minutes after loading dose
|
119.0 mmHg
Standard Deviation 17.1
|
108.0 mmHg
Standard Deviation 6.4
|
|
Systolic Blood Pressure
120 minutes after loading dose
|
116.7 mmHg
Standard Deviation 12.2
|
111.4 mmHg
Standard Deviation 9.5
|
|
Systolic Blood Pressure
300 minutes after loading dose
|
110.4 mmHg
Standard Deviation 11.9
|
105.0 mmHg
Standard Deviation 10.9
|
Adverse Events
PK-1 Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PK-2 Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ann M. Rasmusson, MD
Boston Medical Center/Boston University Chobanian and Avedisian School of Medicine
Phone: 617-358-1871
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place