Trial Outcomes & Findings for A Pharmacokinetic Study of Intravenous and Intranasal Oxytocin in Healthy Subjects (NCT NCT05672667)

Results Overview

Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

25 participants

Primary outcome timeframe

2 minutes after oxytocin infusion initiated

Results posted on

2025-02-17

Participant Flow

Subjects were enrolled between February, 2023 and August, 2023, and were recruited by IRB approved advertisements in the local community as well as direct contacting in a list of subjects who requested they be contacted regarding new research studies.

Participant milestones

Participant milestones
Measure	Oxytocin Administration (Intravenous, Then Intranasal) Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.
Overall Study STARTED	25
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Oxytocin Administration (Intravenous, Then Intranasal) Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.
Overall Study Vasovagal reaction with IV cannulation. Oxytocin was not infused and subject was withdrawn.	1

Baseline Characteristics

A Pharmacokinetic Study of Intravenous and Intranasal Oxytocin in Healthy Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oxytocin Administration (Intravenous, Then Intranasal) n=25 Participants Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	40 years STANDARD_DEVIATION 18 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 minutes after oxytocin infusion initiated

Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration

Outcome measures

Outcome measures
Measure	Oxytocin Administration (Intravenous, Then Intranasal) n=24 Participants Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.
Plasma Oxytocin Concentration 2 Minutes After Infusion Initiated	105 picograms/ml of oxytocin Standard Deviation 47

PRIMARY outcome

Timeframe: 5 minutes after oxytocin infusion initiated

Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration

Outcome measures

Outcome measures
Measure	Oxytocin Administration (Intravenous, Then Intranasal) n=24 Participants Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.
Plasma Oxytocin Concentration 5 Minutes After Infusion Initiated	257 picograms/ml of oxytocin Standard Deviation 80

PRIMARY outcome

Timeframe: 10 minutes after oxytocin infusion initiated

Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration

Outcome measures

Outcome measures
Measure	Oxytocin Administration (Intravenous, Then Intranasal) n=24 Participants Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.
Plasma Oxytocin Concentration 10 Minutes After Infusion Initiated	365 picograms/ml of oxytocin Standard Deviation 77

PRIMARY outcome

Timeframe: 20 minutes after oxytocin infusion initiated

Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration

Outcome measures

Outcome measures
Measure	Oxytocin Administration (Intravenous, Then Intranasal) n=24 Participants Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.
Plasma Oxytocin Concentration 20 Minutes After Infusion Initiated	452 picograms/ml of oxytocin Standard Deviation 89

PRIMARY outcome

Timeframe: 30 minutes after oxytocin infusion initiated

Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration

Outcome measures

Outcome measures
Measure	Oxytocin Administration (Intravenous, Then Intranasal) n=24 Participants Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.
Plasma Oxytocin Concentration 30 Minutes After Infusion Initiated	462 picograms/ml of oxytocin Standard Deviation 139

PRIMARY outcome

Timeframe: 40 minutes after oxytocin infusion initiated

Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration

Outcome measures

Outcome measures
Measure	Oxytocin Administration (Intravenous, Then Intranasal) n=24 Participants Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.
Plasma Oxytocin Concentration 40 Minutes After Infusion Initiated	193 picograms/ml of oxytocin Standard Deviation 79

PRIMARY outcome

Timeframe: 50 minutes after oxytocin infusion initiated

Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration

Outcome measures

Outcome measures
Measure	Oxytocin Administration (Intravenous, Then Intranasal) n=24 Participants Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.
Plasma Oxytocin Concentration 50 Minutes After Infusion Initiated	118 picograms/ml of oxytocin Standard Deviation 73

PRIMARY outcome

Timeframe: 65 minutes after oxytocin infusion initiated

Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration

Outcome measures

Outcome measures
Measure	Oxytocin Administration (Intravenous, Then Intranasal) n=24 Participants Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.
Plasma Oxytocin Concentration 65 Minutes After Infusion Initiated	51 picograms/ml of oxytocin Standard Deviation 21

PRIMARY outcome

Timeframe: 90 minutes after oxytocin infusion initiated

Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration

Outcome measures

Outcome measures
Measure	Oxytocin Administration (Intravenous, Then Intranasal) n=24 Participants Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.
Plasma Oxytocin Concentration 90 Minutes After Infusion Initiated	23 picograms/ml of oxytocin Standard Deviation 10

PRIMARY outcome

Timeframe: 120 minutes after oxytocin infusion initiated

Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration

Outcome measures

Outcome measures
Measure	Oxytocin Administration (Intravenous, Then Intranasal) n=24 Participants Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.
Plasma Oxytocin Concentration 120 Minutes After Infusion Initiated	11 picograms/ml of oxytocin Standard Deviation 6

PRIMARY outcome

Timeframe: 1 minute after intranasal oxytocin administration

Population: Samples were obtained from 24 subjects, but only 9 had oxytocin concentrations above the limit of detection of the assay (2 pg/mL).

Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration

Outcome measures

Outcome measures
Measure	Oxytocin Administration (Intravenous, Then Intranasal) n=9 Participants Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.
Plasma Oxytocin Concentration 1 Minute After First Intranasal Puffs	3.4 picograms/ml of oxytocin Standard Deviation 1.1

PRIMARY outcome

Timeframe: 2 minutes after intranasal oxytocin administration

Population: Samples were obtained from 24 subjects, but only 14 had oxytocin concentrations above the limit of detection of the assay (2 pg/mL).

Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration

Outcome measures

Outcome measures
Measure	Oxytocin Administration (Intravenous, Then Intranasal) n=14 Participants Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.
Plasma Oxytocin Concentration 2 Minutes After First Intranasal Puffs	11.7 picograms/ml of oxytocin Standard Deviation 6.6

PRIMARY outcome

Timeframe: 5 minutes after intranasal oxytocin administration

Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration

Outcome measures

Outcome measures
Measure	Oxytocin Administration (Intravenous, Then Intranasal) n=24 Participants Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.
Plasma Oxytocin Concentration 5 Minutes After First Intranasal Puffs	14.2 picograms/ml of oxytocin Standard Deviation 11.5

PRIMARY outcome

Timeframe: 7 minutes after intranasal oxytocin administration

Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration

Outcome measures

Outcome measures
Measure	Oxytocin Administration (Intravenous, Then Intranasal) n=24 Participants Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.
Plasma Oxytocin Concentration 7 Minutes After First Intranasal Puffs	23.5 picograms/ml of oxytocin Standard Deviation 15.7

PRIMARY outcome

Timeframe: 10 minutes after intranasal oxytocin administration

Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration

Outcome measures

Outcome measures
Measure	Oxytocin Administration (Intravenous, Then Intranasal) n=24 Participants Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.
Plasma Oxytocin Concentration 10 Minutes After First Intranasal Puffs	26.5 picograms/ml of oxytocin Standard Deviation 15.3

PRIMARY outcome

Timeframe: 15 minutes after intranasal oxytocin administration

Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration

Outcome measures

Outcome measures
Measure	Oxytocin Administration (Intravenous, Then Intranasal) n=24 Participants Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.
Plasma Oxytocin Concentration 15 Minutes After First Intranasal Puffs	24.5 picograms/ml of oxytocin Standard Deviation 17.5

PRIMARY outcome

Timeframe: 20 minutes after intranasal oxytocin administration

Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration

Outcome measures

Outcome measures
Measure	Oxytocin Administration (Intravenous, Then Intranasal) n=24 Participants Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.
Plasma Oxytocin Concentration 20 Minutes After First Intranasal Puffs	21 picograms/ml of oxytocin Standard Deviation 15.5

PRIMARY outcome

Timeframe: 25 minutes after intranasal oxytocin administration

Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration

Outcome measures

Outcome measures
Measure	Oxytocin Administration (Intravenous, Then Intranasal) n=24 Participants Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.
Plasma Oxytocin Concentration 25 Minutes After First Intranasal Puffs	18.6 picograms/ml of oxytocin Standard Deviation 14.8

PRIMARY outcome

Timeframe: 35 minutes after intranasal oxytocin administration

Population: Samples were obtained from 24 subjects, but only 23 had oxytocin concentrations above the limit of detection of the assay (2 pg/mL).

Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration

Outcome measures

Outcome measures
Measure	Oxytocin Administration (Intravenous, Then Intranasal) n=23 Participants Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.
Plasma Oxytocin Concentration 35 Minutes After First Intranasal Puffs	20.1 picograms/ml of oxytocin Standard Deviation 32.4

PRIMARY outcome

Timeframe: 45 minutes after intranasal oxytocin administration

Population: Samples were obtained from 24 subjects, but only 22 had oxytocin concentrations above the limit of detection of the assay (2 pg/mL).

Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration

Outcome measures

Outcome measures
Measure	Oxytocin Administration (Intravenous, Then Intranasal) n=22 Participants Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.
Plasma Oxytocin Concentration 45 Minutes After First Intranasal Puffs	10.8 picograms/ml of oxytocin Standard Deviation 8.0

PRIMARY outcome

Timeframe: 60 minutes after intranasal oxytocin administration

Population: Samples were obtained from 24 subjects, but only 21 had oxytocin concentrations above the limit of detection of the assay (2 pg/mL).

Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration

Outcome measures

Outcome measures
Measure	Oxytocin Administration (Intravenous, Then Intranasal) n=21 Participants Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.
Plasma Oxytocin Concentration 60 Minutes After First Intranasal Puffs	7.2 picograms/ml of oxytocin Standard Deviation 5.1

Adverse Events

Intravenous Oxytocin Infusion Study Day

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Intranasal Oxytocin Spray Study Day

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intravenous Oxytocin Infusion Study Day n=24 participants at risk Oxytocin 14 micrograms infusion over 30 minutes on first study day.	Intranasal Oxytocin Spray Study Day n=24 participants at risk Oxytocin 102 micrograms by intranasal spray on second study day.
General disorders Feeling of warmth after intravenous oxytocin	12.5% 3/24 • Number of events 3 • 1 week after intravenous oxytocin and 1 week after intranasal oxytocin.	0.00% 0/24 • 1 week after intravenous oxytocin and 1 week after intranasal oxytocin.
Vascular disorders Red face after intravenous oxytocin	4.2% 1/24 • Number of events 1 • 1 week after intravenous oxytocin and 1 week after intranasal oxytocin.	0.00% 0/24 • 1 week after intravenous oxytocin and 1 week after intranasal oxytocin.
General disorders Rhinorrhea after intranasal oxytocin	0.00% 0/24 • 1 week after intravenous oxytocin and 1 week after intranasal oxytocin.	8.3% 2/24 • Number of events 2 • 1 week after intravenous oxytocin and 1 week after intranasal oxytocin.
General disorders Sternutation after intranasal oxytocin	0.00% 0/24 • 1 week after intravenous oxytocin and 1 week after intranasal oxytocin.	8.3% 2/24 • Number of events 2 • 1 week after intravenous oxytocin and 1 week after intranasal oxytocin.

Additional Information

Dr. James Eisenach

Wake Forest University School of Medicine

Phone: 336-716-4182

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place