Trial Outcomes & Findings for Comparison of Inhaled Oxytocin (IH) With Intramuscular (IM) Oxytocin in Pregnant Women and With Intravenous (IV) Oxytocin in Healthy Non-pregnant Women (NCT NCT02999100)

NCT ID: NCT02999100

Last Updated: 2020-03-23

Results Overview

Blood samples were collected at indicated time points to evaluate concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

• Recruitment status: TERMINATED
• Study phase: PHASE1
• Target enrollment: 31 participants
• Primary outcome timeframe: Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose Day 1
• Results posted on: 2020-03-23

Participant Flow

This is a 2 part study: Part 1 enrolled pregnant women, randomized to receive either inhaled (IH) or intramuscular (IM) oxytocin as active management of the third stage of labor. Part 2 enrolled non-pregnant women of childbearing potential and received IH oxytocin and intravenous (IV) oxytocin in a cross over design.

A total of 31 participants were enrolled in the study. This study was terminated due to inability to reliably measure plasma oxytocin levels in women in third stage labor, regardless of administration method (IH, IM or IV).

Participant milestones

Measure	400 mcg Oxytocin IH Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labor (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Contraceptives+400 mcg Oxytocin IH, Then 8.5mcg Oxytocin IV Healthy participants of childbearing potential were administered oral contraceptive along with 400 mcg oxytocin IH during Session 1 and received 8.5 mcg oxytocin IV during Session 2. Participants were followed up in-person or via telephone within 7 days and no greater than 21 days after last study drug administration.	Contraceptives+8.5mcg Oxytocin IV, Then 400 mcg Oxytocin IH Healthy participants of childbearing potential were administered oral contraceptives along with 8.5 mcg oxytocin IV during Session 1 and received 400 mcg oxytocin IH during Session 2. Participants were followed up in-person or via telephone within 7 days and no greater than 21 days after last study drug administration.	400 mcg Oxytocin IH, Then 8.5 mcg Oxytocin IV Healthy participants of childbearing potential were administered 400 mcg oxytocin IH during Session 1 and received 8.5 mcg oxytocin IV during Session 2. Participants were followed up in-person or via telephone within 7 days and no greater than 21 days after last study drug administration.	8.5 mcg Oxytocin IV, Then 400 mcg Oxytocin IH Healthy participants of childbearing potential were administered 8.5 mcg oxytocin IV during Session 1 and received 400 mcg oxytocin IH during Session 2. Participants were followed up in-person or via telephone within 7 days and no greater than 21 days after last study drug administration.
Part 1 (up to 15 Days) STARTED	9	8	0	0	0	0
Part 1 (up to 15 Days) COMPLETED	9	7	0	0	0	0
Part 1 (up to 15 Days) NOT COMPLETED	0	1	0	0	0	0
Part 2 (Day 1): Dosing Session 1 STARTED	0	0	5	3	3	3
Part 2 (Day 1): Dosing Session 1 COMPLETED	0	0	4	3	3	2
Part 2 (Day 1): Dosing Session 1 NOT COMPLETED	0	0	1	0	0	1
Part 2 (Day 14): Dosing Session 2 STARTED	0	0	4	3	3	2
Part 2 (Day 14): Dosing Session 2 COMPLETED	0	0	4	3	3	2
Part 2 (Day 14): Dosing Session 2 NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Measure	400 mcg Oxytocin IH Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labor (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Contraceptives+400 mcg Oxytocin IH, Then 8.5mcg Oxytocin IV Healthy participants of childbearing potential were administered oral contraceptive along with 400 mcg oxytocin IH during Session 1 and received 8.5 mcg oxytocin IV during Session 2. Participants were followed up in-person or via telephone within 7 days and no greater than 21 days after last study drug administration.	Contraceptives+8.5mcg Oxytocin IV, Then 400 mcg Oxytocin IH Healthy participants of childbearing potential were administered oral contraceptives along with 8.5 mcg oxytocin IV during Session 1 and received 400 mcg oxytocin IH during Session 2. Participants were followed up in-person or via telephone within 7 days and no greater than 21 days after last study drug administration.	400 mcg Oxytocin IH, Then 8.5 mcg Oxytocin IV Healthy participants of childbearing potential were administered 400 mcg oxytocin IH during Session 1 and received 8.5 mcg oxytocin IV during Session 2. Participants were followed up in-person or via telephone within 7 days and no greater than 21 days after last study drug administration.	8.5 mcg Oxytocin IV, Then 400 mcg Oxytocin IH Healthy participants of childbearing potential were administered 8.5 mcg oxytocin IV during Session 1 and received 400 mcg oxytocin IH during Session 2. Participants were followed up in-person or via telephone within 7 days and no greater than 21 days after last study drug administration.
Part 1 (up to 15 Days) Adverse Event	0	1	0	0	0	0
Part 2 (Day 1): Dosing Session 1 Withdrawal by Subject	0	0	0	0	0	1
Part 2 (Day 1): Dosing Session 1 Protocol Violation	0	0	1	0	0	0

Baseline Characteristics

Comparison of Inhaled Oxytocin (IH) With Intramuscular (IM) Oxytocin in Pregnant Women and With Intravenous (IV) Oxytocin in Healthy Non-pregnant Women

Baseline characteristics by cohort

Measure	400 mcg Oxytocin IH n=9 Participants Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labor (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM n=8 Participants Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Contraceptives+400 mcg Oxytocin IH, Then 8.5mcg Oxytocin IV n=5 Participants Healthy participants of childbearing potential were administered oral contraceptive along with 400 mcg oxytocin IH during Session 1 and received 8.5 mcg oxytocin IV during Session 2. Participants were followed up in-person or via telephone within 7 days and no greater than 21 days after last study drug administration.	Contraceptives+8.5mcg Oxytocin IV, Then 400 mcg Oxytocin IH n=3 Participants Healthy participants of childbearing potential were administered oral contraceptives along with 8.5 mcg oxytocin IV during Session 1 and received 400 mcg oxytocin IH during Session 2. Participants were followed up in-person or via telephone within 7 days and no greater than 21 days after last study drug administration.	400 mcg Oxytocin IH, Then 8.5 mcg Oxytocin IV n=3 Participants Healthy participants of childbearing potential were administered 400 mcg oxytocin IH during Session 1 and received 8.5 mcg oxytocin IV during Session 2. Participants were followed up in-person or via telephone within 7 days and no greater than 21 days after last study drug administration.	8.5 mcg Oxytocin IV, Then 400 mcg Oxytocin IH n=3 Participants Healthy participants of childbearing potential were administered 8.5 mcg oxytocin IV during Session 1 and received 400 mcg oxytocin IH during Session 2. Participants were followed up in-person or via telephone within 7 days and no greater than 21 days after last study drug administration.	Total n=31 Participants Total of all reporting groups
Age, Continuous	31.8 Years STANDARD_DEVIATION 3.49 • n=5 Participants	28.1 Years STANDARD_DEVIATION 5.84 • n=7 Participants	24.0 Years STANDARD_DEVIATION 4.53 • n=5 Participants	30.7 Years STANDARD_DEVIATION 0.58 • n=4 Participants	37.3 Years STANDARD_DEVIATION 1.53 • n=21 Participants	27.7 Years STANDARD_DEVIATION 6.66 • n=10 Participants	29.6 Years STANDARD_DEVIATION 5.55 • n=115 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	8 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=10 Participants	31 Participants n=115 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	7 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=10 Participants	25 Participants n=115 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race/Ethnicity, Customized Mixed race	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants

PRIMARY outcome

Timeframe: Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose Day 1

Population: Pharmacokinetic Population includes all participants in Safety population for whom a pharmacokinetic sample was obtained \& analysed.Safety Population includes participants who received at least one dose of study medication.Only those participants with data available at specified data points were analyzed (represented by n= X in the category titles)

Blood samples were collected at indicated time points to evaluate concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	400 mcg Oxytocin IH n=9 Participants Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM n=8 Participants Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.	Non-Combined Oral Contraceptives+400 mcg Oxytocin IH Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
Part 1: Plasma Concentration Time Profile of Oxytocin Pre-dose; n=9, 8	0.000 Picograms per milliliter Interval 0.0 to 5.32	0.000 Picograms per milliliter Interval 0.0 to 0.0	—	—	—	—
Part 1: Plasma Concentration Time Profile of Oxytocin 3 minutes post dose; n= 7, 7	0.000 Picograms per milliliter Interval 0.0 to 33.54	0.000 Picograms per milliliter Interval 0.0 to 0.0	—	—	—	—
Part 1: Plasma Concentration Time Profile of Oxytocin 5 minutes post dose; n=8, 7	1.020 Picograms per milliliter Interval 0.0 to 35.96	0.000 Picograms per milliliter Interval 0.0 to 4.35	—	—	—	—
Part 1: Plasma Concentration Time Profile of Oxytocin 10 minutes post dose; n=7, 8	0.000 Picograms per milliliter Interval 0.0 to 24.58	0.000 Picograms per milliliter Interval 0.0 to 4.5	—	—	—	—
Part 1: Plasma Concentration Time Profile of Oxytocin 15 minutes post dose; n=8, 8	0.000 Picograms per milliliter Interval 0.0 to 13.67	0.000 Picograms per milliliter Interval 0.0 to 3.61	—	—	—	—
Part 1: Plasma Concentration Time Profile of Oxytocin 20 minutes post dose; n=8, 6	0.000 Picograms per milliliter Interval 0.0 to 8.7	0.000 Picograms per milliliter Interval 0.0 to 3.19	—	—	—	—
Part 1: Plasma Concentration Time Profile of Oxytocin 30 minutes post dose; n=8, 7	0.000 Picograms per milliliter Interval 0.0 to 8.46	0.000 Picograms per milliliter Interval 0.0 to 3.53	—	—	—	—
Part 1: Plasma Concentration Time Profile of Oxytocin 1 hour post dose; n=8, 7	0.000 Picograms per milliliter Interval 0.0 to 0.0	0.000 Picograms per milliliter Interval 0.0 to 2.84	—	—	—	—
Part 1: Plasma Concentration Time Profile of Oxytocin 2 hours post dose; n=9, 7	0.000 Picograms per milliliter Interval 0.0 to 0.0	0.000 Picograms per milliliter Interval 0.0 to 0.0	—	—	—	—
Part 1: Plasma Concentration Time Profile of Oxytocin 2.5 hours post dose; n=9, 7	0.000 Picograms per milliliter Interval 0.0 to 3.54	0.000 Picograms per milliliter Interval 0.0 to 0.0	—	—	—	—
Part 1: Plasma Concentration Time Profile of Oxytocin 3 hours post dose; n=8, 7	0.000 Picograms per milliliter Interval 0.0 to 0.0	0.000 Picograms per milliliter Interval 0.0 to 0.0	—	—	—	—
Part 1: Plasma Concentration Time Profile of Oxytocin 4 hours post dose; n=8, 7	0.000 Picograms per milliliter Interval 0.0 to 0.0	0.000 Picograms per milliliter Interval 0.0 to 0.0	—	—	—	—

PRIMARY outcome

Timeframe: Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose Day 1

Population: Pharmacokinetic Population.

Blood samples were collected at indicated time points to evaluate Cmax of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	400 mcg Oxytocin IH n=9 Participants Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM n=8 Participants Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.	Non-Combined Oral Contraceptives+400 mcg Oxytocin IH Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
Part 1: Maximum Observed Plasma Concentration (Cmax) of Oxytocin	2.460 Picograms per milliliter Interval to 35.96 NA indicates that lower range could not be calculated due to high proportion of non-quantifiable \[NQ\] values (more than 50% of values were imputed i.e., NQ assigned zero concentration) which affected the calculation.	NA Picograms per milliliter Interval to 4.5 NA indicates that median and lower range could not be calculated due to high proportion of non-quantifiable \[NQ\] values (more than 50% of values were imputed i.e., NQ assigned zero concentration) which affected the calculation.	—	—	—	—

PRIMARY outcome

Timeframe: 10 minutes post dose Day 1

Population: Pharmacokinetic Population.

Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	400 mcg Oxytocin IH n=9 Participants Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM n=8 Participants Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.	Non-Combined Oral Contraceptives+400 mcg Oxytocin IH Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
Part 1: Observed Plasma Concentration (Cp) 10 of Oxytocin	NA Picogram per milliliter Interval to 24.58 NA indicates that median and lower range could not be calculated as values at specified time points (10 minutes post-dose) were below the limit of quantification.	NA Picogram per milliliter Interval to 4.5 NA indicates that median and lower range could not be calculated as values at specified time points (10 minutes post-dose) were below the limit of quantification.	—	—	—	—

PRIMARY outcome

Timeframe: 20 minutes post dose Day 1

Population: Pharmacokinetic Population.

Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	400 mcg Oxytocin IH n=9 Participants Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM n=8 Participants Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.	Non-Combined Oral Contraceptives+400 mcg Oxytocin IH Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
Part 1: Observed Plasma Concentration (Cp) 20 of Oxytocin	NA Picogram per milliliter Interval to 8.7 NA indicates that median and lower range could not be calculated as values at specified time points (20 minutes post-dose) were below the limit of quantification.	1.960 Picogram per milliliter Interval to 3.19 NA indicates that lower range could not be calculated as values at specified time points (20 minutes post-dose) were below the limit of quantification.	—	—	—	—

PRIMARY outcome

Timeframe: 30 minutes post dose Day 1

Population: Pharmacokinetic Population.

Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	400 mcg Oxytocin IH n=9 Participants Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM n=8 Participants Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.	Non-Combined Oral Contraceptives+400 mcg Oxytocin IH Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
Part 1: Observed Plasma Concentration (Cp) 30 of Oxytocin	NA Picogram per milliliter Interval to 8.46 NA indicates that median and lower range could not be calculated as values at specified time points (30 minutes post-dose) were below the limit of quantification.	NA Picogram per milliliter Interval to 3.53 NA indicates that median and lower range could not be calculated as values at specified time points (30 minutes post-dose) were below the limit of quantification.	—	—	—	—

PRIMARY outcome

Timeframe: Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose Day 1

Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at indicated time points to evaluate Tmax of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	400 mcg Oxytocin IH n=6 Participants Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM n=3 Participants Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.	Non-Combined Oral Contraceptives+400 mcg Oxytocin IH Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
Part 1: Time to Reach Maximum Observed Concentration (Tmax) of Oxytocin	0.15000 Hours Interval 0.05 to 2.5	0.25000 Hours Interval 0.1667 to 0.4833	—	—	—	—

PRIMARY outcome

Timeframe: Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose on Day 1

Population: Pharmacokinetic Population.

Blood samples were collected at indicated time points to evaluate AUC (0-t) of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	400 mcg Oxytocin IH n=9 Participants Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM n=8 Participants Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.	Non-Combined Oral Contraceptives+400 mcg Oxytocin IH Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
Part 1: Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) of Oxytocin	NA Hour*picogram per milliliter Interval to 8.1 NA indicates that median and lower range could not be calculated due to high proportion of non-quantifiable \[NQ\] values (more than 50% of values were imputed i.e., NQ assigned zero concentration) which affected the calculation.	NA Hour*picogram per milliliter Interval to 2.3 NA indicates that median and lower range could not be calculated due to high proportion of non-quantifiable \[NQ\] values (more than 50% of values were imputed i.e., NQ assigned zero concentration) which affected the calculation.	—	—	—	—

PRIMARY outcome

Timeframe: Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose on Day 1

Population: Pharmacokinetic Population.

Blood samples were collected at indicated time points to evaluate t1/2 of oxytocin.

Outcome measures

Measure	400 mcg Oxytocin IH n=9 Participants Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM n=8 Participants Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.	Non-Combined Oral Contraceptives+400 mcg Oxytocin IH Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
Part 1: Terminal Phase Half-life (t1/2) of Oxytocin	NA Hours NA indicates that data could not be calculated as all values in terminal elimination phase were below the limit of quantification.	NA Hours NA indicates that data could not be calculated as all values in terminal elimination phase were below the limit of quantification.	—	—	—	—

PRIMARY outcome

Timeframe: Up to 37 days

Population: Safety Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.

An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. As SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Safety Population includes participants who received at least one dose of study medication.

Outcome measures

Measure	400 mcg Oxytocin IH n=7 Participants Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM n=5 Participants Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion n=2 Participants Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.	Non-Combined Oral Contraceptives+400 mcg Oxytocin IH n=5 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus n=1 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion n=5 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
Part 2: Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) Any non-SAE	7 Participants	5 Participants	1 Participants	3 Participants	1 Participants	5 Participants
Part 2: Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) Any SAE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post dose

Population: Safety Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.

Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest.

Outcome measures

Measure	400 mcg Oxytocin IH n=7 Participants Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM n=5 Participants Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion n=2 Participants Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.	Non-Combined Oral Contraceptives+400 mcg Oxytocin IH n=5 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus n=1 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion n=5 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP: 5 minutes	114.0 Millimeters of mercury Standard Deviation 6.16	118.2 Millimeters of mercury Standard Deviation 9.76	103.5 Millimeters of mercury Standard Deviation 9.19	108.4 Millimeters of mercury Standard Deviation 10.71	104.0 Millimeters of mercury Standard Deviation NA NA indicates that SD could not be calculated for a single participant	110.6 Millimeters of mercury Standard Deviation 15.14
Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP: Pre-dose	107.1 Millimeters of mercury Standard Deviation 5.24	116.0 Millimeters of mercury Standard Deviation 12.73	102.0 Millimeters of mercury Standard Deviation 5.66	105.4 Millimeters of mercury Standard Deviation 10.11	99.0 Millimeters of mercury Standard Deviation NA NA indicates that standard deviation (SD) could not be calculated for a single participant	107.2 Millimeters of mercury Standard Deviation 6.61
Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP: 15 minutes	108.9 Millimeters of mercury Standard Deviation 3.29	114.6 Millimeters of mercury Standard Deviation 9.40	106.0 Millimeters of mercury Standard Deviation 5.66	106.4 Millimeters of mercury Standard Deviation 9.50	98.0 Millimeters of mercury Standard Deviation NA NA indicates that SD could not be calculated for a single participant	106.0 Millimeters of mercury Standard Deviation 10.07
Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP: 30 minutes	109.6 Millimeters of mercury Standard Deviation 4.04	111.2 Millimeters of mercury Standard Deviation 6.87	107.0 Millimeters of mercury Standard Deviation 8.49	113.2 Millimeters of mercury Standard Deviation 12.05	100.0 Millimeters of mercury Standard Deviation NA NA indicates that SD could not be calculated for a single participant	104.6 Millimeters of mercury Standard Deviation 10.95
Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP: 1 hour	104.9 Millimeters of mercury Standard Deviation 6.26	111.4 Millimeters of mercury Standard Deviation 5.37	103.5 Millimeters of mercury Standard Deviation 2.12	108.8 Millimeters of mercury Standard Deviation 8.64	98.0 Millimeters of mercury Standard Deviation NA NA indicates that SD could not be calculated for a single participant	109.0 Millimeters of mercury Standard Deviation 12.61
Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP: 4 hours	106.9 Millimeters of mercury Standard Deviation 5.11	111.4 Millimeters of mercury Standard Deviation 11.28	106.5 Millimeters of mercury Standard Deviation 3.54	102.0 Millimeters of mercury Standard Deviation 9.41	93.0 Millimeters of mercury Standard Deviation NA NA indicates that SD could not be calculated for a single participant	106.4 Millimeters of mercury Standard Deviation 3.21
Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP: Pre-dose	65.1 Millimeters of mercury Standard Deviation 5.93	62.4 Millimeters of mercury Standard Deviation 7.54	67.0 Millimeters of mercury Standard Deviation 1.41	62.0 Millimeters of mercury Standard Deviation 6.36	58.0 Millimeters of mercury Standard Deviation NA NA indicates that SD could not be calculated for a single participant	64.2 Millimeters of mercury Standard Deviation 8.29
Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP: 5 minutes	67.1 Millimeters of mercury Standard Deviation 7.67	67.0 Millimeters of mercury Standard Deviation 8.15	61.5 Millimeters of mercury Standard Deviation 7.78	65.2 Millimeters of mercury Standard Deviation 3.03	67.0 Millimeters of mercury Standard Deviation NA NA indicates that SD could not be calculated for a single participant	60.4 Millimeters of mercury Standard Deviation 5.68
Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP: 15 minutes	65.4 Millimeters of mercury Standard Deviation 5.62	64.8 Millimeters of mercury Standard Deviation 7.43	65.5 Millimeters of mercury Standard Deviation 4.95	65.6 Millimeters of mercury Standard Deviation 3.36	68.0 Millimeters of mercury Standard Deviation NA NA indicates that SD could not be calculated for a single participant	62.4 Millimeters of mercury Standard Deviation 5.77
Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP: 30 minutes	68.3 Millimeters of mercury Standard Deviation 6.07	65.2 Millimeters of mercury Standard Deviation 3.11	66.5 Millimeters of mercury Standard Deviation 4.95	69.6 Millimeters of mercury Standard Deviation 6.73	70.0 Millimeters of mercury Standard Deviation NA NA indicates that SD could not be calculated for a single participant	63.0 Millimeters of mercury Standard Deviation 5.48
Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP: 1 hour	65.9 Millimeters of mercury Standard Deviation 4.85	65.8 Millimeters of mercury Standard Deviation 3.56	69.0 Millimeters of mercury Standard Deviation 5.66	66.6 Millimeters of mercury Standard Deviation 2.41	65.0 Millimeters of mercury Standard Deviation NA NA indicates that SD could not be calculated for a single participant	66.4 Millimeters of mercury Standard Deviation 9.21
Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP: 4 hours	66.4 Millimeters of mercury Standard Deviation 7.57	61.6 Millimeters of mercury Standard Deviation 6.99	64.5 Millimeters of mercury Standard Deviation 9.19	60.0 Millimeters of mercury Standard Deviation 6.52	62.0 Millimeters of mercury Standard Deviation NA NA indicates that SD could not be calculated for a single participant	59.2 Millimeters of mercury Standard Deviation 5.07

PRIMARY outcome

Timeframe: Baseline (Day 1, pre-dose), 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post dose

Population: Safety Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.

SBP and DBP of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

Outcome measures

Measure	400 mcg Oxytocin IH n=7 Participants Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM n=5 Participants Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion n=2 Participants Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.	Non-Combined Oral Contraceptives+400 mcg Oxytocin IH n=5 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus n=1 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion n=5 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
Part 2: Change From Baseline in SBP and DBP SBP: 5 minutes	6.9 Millimeters of mercury Standard Deviation 6.47	2.2 Millimeters of mercury Standard Deviation 13.42	1.5 Millimeters of mercury Standard Deviation 3.54	3.0 Millimeters of mercury Standard Deviation 10.42	5.0 Millimeters of mercury Standard Deviation NA NA indicates that SD could not be calculated for a single participant	3.4 Millimeters of mercury Standard Deviation 10.88
Part 2: Change From Baseline in SBP and DBP SBP: 15 minutes	1.7 Millimeters of mercury Standard Deviation 3.25	-1.4 Millimeters of mercury Standard Deviation 14.67	4.0 Millimeters of mercury Standard Deviation 0.00	1.0 Millimeters of mercury Standard Deviation 11.02	-1.0 Millimeters of mercury Standard Deviation NA NA indicates that SD could not be calculated for a single participant	-1.2 Millimeters of mercury Standard Deviation 6.98
Part 2: Change From Baseline in SBP and DBP SBP: 30 minutes	2.4 Millimeters of mercury Standard Deviation 2.07	-4.8 Millimeters of mercury Standard Deviation 13.35	5.0 Millimeters of mercury Standard Deviation 2.83	7.8 Millimeters of mercury Standard Deviation 12.56	1.0 Millimeters of mercury Standard Deviation NA NA indicates that SD could not be calculated for a single participant	-2.6 Millimeters of mercury Standard Deviation 7.80
Part 2: Change From Baseline in SBP and DBP SBP: 1 hour	-2.3 Millimeters of mercury Standard Deviation 4.27	-4.6 Millimeters of mercury Standard Deviation 14.10	1.5 Millimeters of mercury Standard Deviation 3.54	3.4 Millimeters of mercury Standard Deviation 13.54	-1.0 Millimeters of mercury Standard Deviation NA NA indicates that SD could not be calculated for a single participant	1.8 Millimeters of mercury Standard Deviation 9.71
Part 2: Change From Baseline in SBP and DBP SBP: 4 hours	-0.3 Millimeters of mercury Standard Deviation 3.82	-4.6 Millimeters of mercury Standard Deviation 13.79	4.5 Millimeters of mercury Standard Deviation 2.12	-3.4 Millimeters of mercury Standard Deviation 9.29	-6.0 Millimeters of mercury Standard Deviation NA NA indicates that SD could not be calculated for a single participant	-0.8 Millimeters of mercury Standard Deviation 7.95
Part 2: Change From Baseline in SBP and DBP DBP: 5 minutes	2.0 Millimeters of mercury Standard Deviation 10.69	4.6 Millimeters of mercury Standard Deviation 3.58	-5.5 Millimeters of mercury Standard Deviation 9.19	3.2 Millimeters of mercury Standard Deviation 6.46	9.0 Millimeters of mercury Standard Deviation NA NA indicates that SD could not be calculated for a single participant	-3.8 Millimeters of mercury Standard Deviation 3.35
Part 2: Change From Baseline in SBP and DBP DBP: 15 minutes	0.3 Millimeters of mercury Standard Deviation 6.92	2.4 Millimeters of mercury Standard Deviation 7.70	-1.5 Millimeters of mercury Standard Deviation 6.36	3.6 Millimeters of mercury Standard Deviation 4.28	10.0 Millimeters of mercury Standard Deviation NA NA indicates that SD could not be calculated for a single participant	-1.8 Millimeters of mercury Standard Deviation 5.50
Part 2: Change From Baseline in SBP and DBP DBP: 30 minutes	3.1 Millimeters of mercury Standard Deviation 7.88	2.8 Millimeters of mercury Standard Deviation 8.04	-0.5 Millimeters of mercury Standard Deviation 6.36	7.6 Millimeters of mercury Standard Deviation 9.94	12.0 Millimeters of mercury Standard Deviation NA NA indicates that SD could not be calculated for a single participant	-1.2 Millimeters of mercury Standard Deviation 4.87
Part 2: Change From Baseline in SBP and DBP DBP: 1 hour	0.7 Millimeters of mercury Standard Deviation 3.35	3.4 Millimeters of mercury Standard Deviation 6.54	2.0 Millimeters of mercury Standard Deviation 7.07	4.6 Millimeters of mercury Standard Deviation 3.97	7.0 Millimeters of mercury Standard Deviation NA NA indicates that SD could not be calculated for a single participant	2.2 Millimeters of mercury Standard Deviation 2.95
Part 2: Change From Baseline in SBP and DBP DBP: 4 hours	1.3 Millimeters of mercury Standard Deviation 8.20	-0.8 Millimeters of mercury Standard Deviation 4.97	-2.5 Millimeters of mercury Standard Deviation 10.61	-2.0 Millimeters of mercury Standard Deviation 3.24	4.0 Millimeters of mercury Standard Deviation NA NA indicates that SD could not be calculated for a single participant	-5.0 Millimeters of mercury Standard Deviation 6.63

PRIMARY outcome

Timeframe: Baseline (Day 1, pre-dose), 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post dose

Population: Safety Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.

Heart rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

Outcome measures

Measure	400 mcg Oxytocin IH n=7 Participants Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM n=5 Participants Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion n=2 Participants Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.	Non-Combined Oral Contraceptives+400 mcg Oxytocin IH n=5 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus n=1 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion n=5 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
Part 2: Change From Baseline in Heart Rate 30 minutes	-1.9 Beats per minute Standard Deviation 7.29	1.2 Beats per minute Standard Deviation 11.34	1 Beats per minute Standard Deviation 1.41	-3.6 Beats per minute Standard Deviation 11.74	-9.0 Beats per minute Standard Deviation NA NA indicates that SD could not be calculated for a single participant	-0.2 Beats per minute Standard Deviation 4.09
Part 2: Change From Baseline in Heart Rate 5 minutes	2.9 Beats per minute Standard Deviation 6.99	13.8 Beats per minute Standard Deviation 11.86	19.5 Beats per minute Standard Deviation 3.54	7.4 Beats per minute Standard Deviation 13.05	-7.0 Beats per minute Standard Deviation NA NA indicates that SD could not be calculated for a single participant	13.0 Beats per minute Standard Deviation 7.52
Part 2: Change From Baseline in Heart Rate 15 minutes	2.9 Beats per minute Standard Deviation 11.51	4.4 Beats per minute Standard Deviation 9.4	7 Beats per minute Standard Deviation 7.07	2.6 Beats per minute Standard Deviation 12.44	-7.0 Beats per minute Standard Deviation NA NA indicates that SD could not be calculated for a single participant	0.6 Beats per minute Standard Deviation 3.29
Part 2: Change From Baseline in Heart Rate 1 hour	-5.9 Beats per minute Standard Deviation 7.15	2.2 Beats per minute Standard Deviation 8.56	4.5 Beats per minute Standard Deviation 6.36	-1.4 Beats per minute Standard Deviation 10.04	-10.0 Beats per minute Standard Deviation NA NA indicates that SD could not be calculated for a single participant	0.2 Beats per minute Standard Deviation 3.96
Part 2: Change From Baseline in Heart Rate 4 hours	3.1 Beats per minute Standard Deviation 6.49	5.8 Beats per minute Standard Deviation 11.5	9 Beats per minute Standard Deviation 22.63	6.2 Beats per minute Standard Deviation 5.4	-6.0 Beats per minute Standard Deviation NA NA indicates that SD could not be calculated for a single participant	5.8 Beats per minute Standard Deviation 3.49

PRIMARY outcome

Timeframe: Pre dose, 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post dose

Population: Safety Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.

Heart rate was measured in semi-supine position after 5 minutes rest

Outcome measures

Measure	400 mcg Oxytocin IH n=7 Participants Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM n=5 Participants Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion n=2 Participants Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.	Non-Combined Oral Contraceptives+400 mcg Oxytocin IH n=5 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus n=1 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion n=5 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
Part 2: Absolute Values of Heart Rate Pre dose	71.1 Beats per minute Standard Deviation 15.29	65.2 Beats per minute Standard Deviation 5.93	63.5 Beats per minute Standard Deviation 21.92	65 Beats per minute Standard Deviation 9.3	81.0 Beats per minute Standard Deviation NA NA indicates that SD could not be calculated for a single participant	63.6 Beats per minute Standard Deviation 13.46
Part 2: Absolute Values of Heart Rate 5 minutes	74.0 Beats per minute Standard Deviation 15.01	79 Beats per minute Standard Deviation 8.15	83 Beats per minute Standard Deviation 18.38	72.4 Beats per minute Standard Deviation 14.1	74.0 Beats per minute Standard Deviation NA NA indicates that SD could not be calculated for a single participant	76.6 Beats per minute Standard Deviation 18.5
Part 2: Absolute Values of Heart Rate 15 minutes	74.0 Beats per minute Standard Deviation 10.31	69.6 Beats per minute Standard Deviation 5.64	70.5 Beats per minute Standard Deviation 14.85	67.6 Beats per minute Standard Deviation 11.93	74.0 Beats per minute Standard Deviation NA NA indicates that SD could not be calculated for a single participant	64.2 Beats per minute Standard Deviation 16.3
Part 2: Absolute Values of Heart Rate 30 minutes	69.3 Beats per minute Standard Deviation 9.32	66.4 Beats per minute Standard Deviation 6.47	64.5 Beats per minute Standard Deviation 23.33	61.4 Beats per minute Standard Deviation 7.96	72.0 Beats per minute Standard Deviation NA NA indicates that SD could not be calculated for a single participant	63.4 Beats per minute Standard Deviation 13.22
Part 2: Absolute Values of Heart Rate 1 hour	65.3 Beats per minute Standard Deviation 10.59	67.4 Beats per minute Standard Deviation 4.67	68 Beats per minute Standard Deviation 15.56	63.6 Beats per minute Standard Deviation 11.24	71.0 Beats per minute Standard Deviation NA NA indicates that SD could not be calculated for a single participant	63.8 Beats per minute Standard Deviation 13.12
Part 2: Absolute Values of Heart Rate 4 hours	74.3 Beats per minute Standard Deviation 13.21	71 Beats per minute Standard Deviation 5.7	72.5 Beats per minute Standard Deviation 0.71	71.2 Beats per minute Standard Deviation 5.54	75.0 Beats per minute Standard Deviation NA NA indicates that SD could not be calculated for a single participant	69.4 Beats per minute Standard Deviation 15.11

PRIMARY outcome

Timeframe: Pre-dose, 2 minutes, 10 minutes, 20 minutes, 30 minutes, 1 hour and 4 hours post dose

Population: Safety Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.

Triplicate 12-lead electrocardiograms (ECGs) were recorded pre-dose and post-dose with participant in semi-supine position after 5 minutes rest. At each time point ECG was taken using an ECG machine that automatically measured PR interval, QRS duration, QTcB interval, and QTcF interval.

Outcome measures

Measure	400 mcg Oxytocin IH n=7 Participants Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM n=5 Participants Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion n=2 Participants Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.	Non-Combined Oral Contraceptives+400 mcg Oxytocin IH n=5 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus n=1 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion n=5 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval QTcF: 4 hours	410.4 Milliseconds Standard Deviation 10.63	409.2 Milliseconds Standard Deviation 17.63	420.5 Milliseconds Standard Deviation 2.12	408.2 Milliseconds Standard Deviation 22.92	410.0 Milliseconds Standard Deviation NA NA indicates that SD could not be calculated for a single participant	415.6 Milliseconds Standard Deviation 12.54
Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval QTcB: 2 minutes	422.3 Milliseconds Standard Deviation 30.97	453.4 Milliseconds Standard Deviation 26.42	464.4 Milliseconds Standard Deviation 8.95	443.1 Milliseconds Standard Deviation 20.62	460.9 Milliseconds Standard Deviation NA NA indicates that SD could not be calculated for a single participant	453.5 Milliseconds Standard Deviation 30.42
Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval QTcB: 1 hour	415.9 Milliseconds Standard Deviation 15.66	419.5 Milliseconds Standard Deviation 24.53	435.4 Milliseconds Standard Deviation 13.98	423.2 Milliseconds Standard Deviation 15.57	436.7 Milliseconds Standard Deviation NA NA indicates that SD could not be calculated for a single participant	419.9 Milliseconds Standard Deviation 25.24
Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval QTcF: 30 minutes	406.4 Milliseconds Standard Deviation 13.96	420.2 Milliseconds Standard Deviation 15.96	411.0 Milliseconds Standard Deviation 19.80	424.6 Milliseconds Standard Deviation 8.20	413.0 Milliseconds Standard Deviation NA NA indicates that SD could not be calculated for a single participant	417.0 Milliseconds Standard Deviation 15.25
Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval QTcF: 1 hour	408.3 Milliseconds Standard Deviation 11.90	416.0 Milliseconds Standard Deviation 20.76	422.5 Milliseconds Standard Deviation 0.71	420.2 Milliseconds Standard Deviation 5.22	418.0 Milliseconds Standard Deviation NA NA indicates that SD could not be calculated for a single participant	416.2 Milliseconds Standard Deviation 18.57
Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval QTcB: Pre-dose	413.2 Milliseconds Standard Deviation 20.41	408.8 Milliseconds Standard Deviation 24.01	413.8 Milliseconds Standard Deviation 26.37	420.4 Milliseconds Standard Deviation 16.10	441.7 Milliseconds Standard Deviation NA NA indicates that SD could not be calculated for a single participant	418.4 Milliseconds Standard Deviation 17.24
Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval PR interval: Pre-dose	150.9 Milliseconds Standard Deviation 23.67	156.0 Milliseconds Standard Deviation 22.17	146.5 Milliseconds Standard Deviation 21.92	139.8 Milliseconds Standard Deviation 23.67	127.0 Milliseconds Standard Deviation NA NA indicates that SD could not be calculated for a single participant	139.6 Milliseconds Standard Deviation 28.32
Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval PR interval: 2 minutes	144.6 Milliseconds Standard Deviation 25.36	158.4 Milliseconds Standard Deviation 24.13	146.5 Milliseconds Standard Deviation 14.85	140.0 Milliseconds Standard Deviation 27.70	125.0 Milliseconds Standard Deviation NA NA indicates that SD could not be calculated for a single participant	147.0 Milliseconds Standard Deviation 30.36
Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval PR interval: 10 minutes	150.9 Milliseconds Standard Deviation 27.90	161.6 Milliseconds Standard Deviation 24.77	143.0 Milliseconds Standard Deviation 21.21	146.2 Milliseconds Standard Deviation 28.65	128.0 Milliseconds Standard Deviation NA NA indicates that SD could not be calculated for a single participant	146.0 Milliseconds Standard Deviation 31.96
Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval PR interval: 20 minutes	152.1 Milliseconds Standard Deviation 29.59	161.2 Milliseconds Standard Deviation 26.40	143.5 Milliseconds Standard Deviation 20.51	147.4 Milliseconds Standard Deviation 28.61	125.0 Milliseconds Standard Deviation NA NA indicates that SD could not be calculated for a single participant	151.0 Milliseconds Standard Deviation 32.08
Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval PR interval: 30 minutes	151.4 Milliseconds Standard Deviation 28.96	158.8 Milliseconds Standard Deviation 25.03	147.0 Milliseconds Standard Deviation 14.14	146.0 Milliseconds Standard Deviation 24.37	128.0 Milliseconds Standard Deviation NA NA indicates that SD could not be calculated for a single participant	151.8 Milliseconds Standard Deviation 30.43
Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval PR interval: 1 hour	154.4 Milliseconds Standard Deviation 28.92	160.4 Milliseconds Standard Deviation 22.88	147.5 Milliseconds Standard Deviation 13.44	146.8 Milliseconds Standard Deviation 27.65	129.0 Milliseconds Standard Deviation NA NA indicates that SD could not be calculated for a single participant	150.0 Milliseconds Standard Deviation 28.24
Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval PR interval: 4 hours	153.1 Milliseconds Standard Deviation 23.43	155.8 Milliseconds Standard Deviation 25.80	145.5 Milliseconds Standard Deviation 16.26	141.6 Milliseconds Standard Deviation 21.09	117.0 Milliseconds Standard Deviation NA NA indicates that SD could not be calculated for a single participant	139.4 Milliseconds Standard Deviation 29.37
Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval QRS duration: Pre-dose	91.4 Milliseconds Standard Deviation 8.20	89.0 Milliseconds Standard Deviation 5.52	99.0 Milliseconds Standard Deviation 7.07	91.4 Milliseconds Standard Deviation 8.85	94.0 Milliseconds Standard Deviation NA NA indicates that SD could not be calculated for a single participant	89.0 Milliseconds Standard Deviation 9.85
Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval QRS duration: 2 minutes	92.7 Milliseconds Standard Deviation 7.11	89.4 Milliseconds Standard Deviation 5.68	104.0 Milliseconds Standard Deviation 4.24	90.4 Milliseconds Standard Deviation 9.32	91.0 Milliseconds Standard Deviation NA NA indicates that SD could not be calculated for a single participant	86.8 Milliseconds Standard Deviation 6.26
Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval QRS duration: 10 minutes	92.3 Milliseconds Standard Deviation 11.01	91.2 Milliseconds Standard Deviation 5.67	98.5 Milliseconds Standard Deviation 9.19	91.2 Milliseconds Standard Deviation 9.18	91.0 Milliseconds Standard Deviation NA NA indicates that SD could not be calculated for a single participant	89.2 Milliseconds Standard Deviation 9.58
Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval QRS duration: 20 minutes	90.7 Milliseconds Standard Deviation 8.96	87.8 Milliseconds Standard Deviation 4.15	91.0 Milliseconds Standard Deviation 18.38	90.2 Milliseconds Standard Deviation 9.55	92.0 Milliseconds Standard Deviation NA NA indicates that SD could not be calculated for a single participant	89.0 Milliseconds Standard Deviation 11.92
Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval QRS duration: 30 minutes	91.3 Milliseconds Standard Deviation 9.27	89.2 Milliseconds Standard Deviation 5.22	100.0 Milliseconds Standard Deviation 0.00	93.4 Milliseconds Standard Deviation 8.88	93.0 Milliseconds Standard Deviation NA NA indicates that SD could not be calculated for a single participant	92.2 Milliseconds Standard Deviation 10.62
Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval QRS: 1 hour	90.9 Milliseconds Standard Deviation 8.15	89.6 Milliseconds Standard Deviation 4.83	99.0 Milliseconds Standard Deviation 1.41	93.2 Milliseconds Standard Deviation 9.34	91.0 Milliseconds Standard Deviation NA NA indicates that SD could not be calculated for a single participant	89.4 Milliseconds Standard Deviation 8.88
Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval QRS: 4 hours	92.3 Milliseconds Standard Deviation 9.52	88.6 Milliseconds Standard Deviation 3.21	106.0 Milliseconds Standard Deviation 8.49	89.0 Milliseconds Standard Deviation 6.04	92.0 Milliseconds Standard Deviation NA NA indicates that SD could not be calculated for a single participant	90.0 Milliseconds Standard Deviation 6.60
Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval QTcF: Pre-dose	401.7 Milliseconds Standard Deviation 11.84	406.0 Milliseconds Standard Deviation 19.51	406.5 Milliseconds Standard Deviation 7.78	413.8 Milliseconds Standard Deviation 12.15	416.0 Milliseconds Standard Deviation NA NA indicates that SD could not be calculated for a single participant	411.6 Milliseconds Standard Deviation 9.63
Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval QTcF: 2 minutes	403.0 Milliseconds Standard Deviation 22.02	422.6 Milliseconds Standard Deviation 21.51	432.5 Milliseconds Standard Deviation 20.51	420.6 Milliseconds Standard Deviation 12.50	426.0 Milliseconds Standard Deviation NA NA indicates that SD could not be calculated for a single participant	427.4 Milliseconds Standard Deviation 19.30
Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval QTcF: 10 minutes	407.0 Milliseconds Standard Deviation 11.18	430.2 Milliseconds Standard Deviation 20.23	413.5 Milliseconds Standard Deviation 13.44	422.6 Milliseconds Standard Deviation 13.15	421.0 Milliseconds Standard Deviation NA NA indicates that SD could not be calculated for a single participant	412.8 Milliseconds Standard Deviation 8.96
Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval QTcF: 20 minutes	407.0 Milliseconds Standard Deviation 14.87	415.2 Milliseconds Standard Deviation 26.22	419.5 Milliseconds Standard Deviation 16.26	422.0 Milliseconds Standard Deviation 8.28	408.0 Milliseconds Standard Deviation NA NA indicates that SD could not be calculated for a single participant	416.6 Milliseconds Standard Deviation 16.29
Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval QTcB: 10 minutes	421.3 Milliseconds Standard Deviation 16.19	443.8 Milliseconds Standard Deviation 22.71	429.0 Milliseconds Standard Deviation 1.98	434.1 Milliseconds Standard Deviation 25.91	439.1 Milliseconds Standard Deviation NA NA indicates that SD could not be calculated for a single participant	421.7 Milliseconds Standard Deviation 18.96
Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval QTcB: 20 minutes	416.0 Milliseconds Standard Deviation 20.89	421.8 Milliseconds Standard Deviation 29.04	425.5 Milliseconds Standard Deviation 2.54	432.9 Milliseconds Standard Deviation 17.19	418.4 Milliseconds Standard Deviation NA NA indicates that SD could not be calculated for a single participant	418.9 Milliseconds Standard Deviation 21.93
Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval QTcB: 30 minutes	415.1 Milliseconds Standard Deviation 22.11	427.8 Milliseconds Standard Deviation 19.67	415.1 Milliseconds Standard Deviation 7.05	431.6 Milliseconds Standard Deviation 18.64	423.9 Milliseconds Standard Deviation NA NA indicates that SD could not be calculated for a single participant	419.6 Milliseconds Standard Deviation 27.77
Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval QTcB: 4 hours	422.4 Milliseconds Standard Deviation 13.29	415.5 Milliseconds Standard Deviation 15.04	439.0 Milliseconds Standard Deviation 7.14	421.9 Milliseconds Standard Deviation 28.51	429.3 Milliseconds Standard Deviation NA NA indicates that SD could not be calculated for a single participant	426.4 Milliseconds Standard Deviation 17.82

PRIMARY outcome

Timeframe: Up to Day 37

Population: Safety Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.

Number of participants with abnormal respiratory events has been presented

Outcome measures

Measure	400 mcg Oxytocin IH n=7 Participants Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM n=5 Participants Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion n=2 Participants Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.	Non-Combined Oral Contraceptives+400 mcg Oxytocin IH n=5 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus n=1 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion n=5 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
Part 2: Number of Participants With Abnormal Respiratory Events	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Pre dose and 1 hour post dose on Day1

Population: Safety Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 measurements were taken electronically by spirometry on Day 1. At each time point, three best measurements were recorded.

Outcome measures

Measure	400 mcg Oxytocin IH n=7 Participants Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM n=5 Participants Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion n=2 Participants Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.	Non-Combined Oral Contraceptives+400 mcg Oxytocin IH n=5 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus n=1 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion n=5 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
Part 2: Forced Expiratory Volume at 1 Minute (FEV1) Pre-dose	3.251 Liters Standard Deviation 0.3125	3.440 Liters Standard Deviation 0.3121	3.130 Liters Standard Deviation 0.0707	3.384 Liters Standard Deviation 0.3051	3.630 Liters Standard Deviation NA NA indicates that SD could not be calculated for a single participant	3.284 Liters Standard Deviation 0.3488
Part 2: Forced Expiratory Volume at 1 Minute (FEV1) 1 hour	3.184 Liters Standard Deviation 0.2769	3.374 Liters Standard Deviation 0.2964	3.110 Liters Standard Deviation 0.1980	3.306 Liters Standard Deviation 0.2874	3.380 Liters Standard Deviation NA NA indicates that SD could not be calculated for a single participant	3.190 Liters Standard Deviation 0.3768

PRIMARY outcome

Timeframe: Pre dose, 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post-dose

Population: Safety Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.

Percent oxygen in blood was measured using pulse oximetry in a semi-supine position after 5 minutes rest. Pulse oximeter is a device that measures oxygen saturation of arterial blood in participants by utilizing a sensor attached typically to a finger, toe, or ear to determine the percentage of oxyhemoglobin in blood pulsating through a network of capillaries

Outcome measures

Measure	400 mcg Oxytocin IH n=7 Participants Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM n=5 Participants Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion n=2 Participants Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.	Non-Combined Oral Contraceptives+400 mcg Oxytocin IH n=5 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus n=1 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion n=5 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
Part 2: Percent Oxygen in Blood 5 minutes	98.9 Percentage of oxygen Standard Deviation 1.21	99.0 Percentage of oxygen Standard Deviation 1.00	99.0 Percentage of oxygen Standard Deviation 1.41	98.0 Percentage of oxygen Standard Deviation 1.41	98.0 Percentage of oxygen Standard Deviation NA NA indicates that SD could not be calculated for a single participant	98.8 Percentage of oxygen Standard Deviation 1.30
Part 2: Percent Oxygen in Blood 15 minutes	98.7 Percentage of oxygen Standard Deviation 1.25	98.8 Percentage of oxygen Standard Deviation 0.84	99.5 Percentage of oxygen Standard Deviation 0.71	97.8 Percentage of oxygen Standard Deviation 1.10	98.0 Percentage of oxygen Standard Deviation NA NA indicates that SD could not be calculated for a single participant	98.4 Percentage of oxygen Standard Deviation 1.14
Part 2: Percent Oxygen in Blood 30 minutes	98.9 Percentage of oxygen Standard Deviation 0.9	98.4 Percentage of oxygen Standard Deviation 1.14	99.5 Percentage of oxygen Standard Deviation 0.71	98.2 Percentage of oxygen Standard Deviation 0.84	98.0 Percentage of oxygen Standard Deviation NA NA indicates that SD could not be calculated for a single participant	98.2 Percentage of oxygen Standard Deviation 1.10
Part 2: Percent Oxygen in Blood 1 hour	98.4 Percentage of oxygen Standard Deviation 1.27	98.2 Percentage of oxygen Standard Deviation 1.3	99.0 Percentage of oxygen Standard Deviation 1.41	98 Percentage of oxygen Standard Deviation 0.71	99.0 Percentage of oxygen Standard Deviation NA NA indicates that SD could not be calculated for a single participant	98.2 Percentage of oxygen Standard Deviation 1.10
Part 2: Percent Oxygen in Blood 4 hours	99.0 Percentage of oxygen Standard Deviation 0.82	98.4 Percentage of oxygen Standard Deviation 0.89	99.5 Percentage of oxygen Standard Deviation 0.71	97.8 Percentage of oxygen Standard Deviation 0.84	99.0 Percentage of oxygen Standard Deviation NA NA indicates that SD could not be calculated for a single participant	98.6 Percentage of oxygen Standard Deviation 1.52
Part 2: Percent Oxygen in Blood Pre dose	98.6 Percentage of oxygen Standard Deviation 1.4	99.4 Percentage of oxygen Standard Deviation 0.89	99.0 Percentage of oxygen Standard Deviation 1.41	97.2 Percentage of oxygen Standard Deviation 0.84	98.0 Percentage of oxygen Standard Deviation NA NA indicates that SD could not be calculated for a single participant	97.4 Percentage of oxygen Standard Deviation 0.89

PRIMARY outcome

Timeframe: Pre dose, 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post-dose

Population: Safety Population. Only those participants with data available at specified data points were analyzed (represented by n=X in category titles). Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.

Respiration rate was measured in semi-supine position after 5 minutes rest

Outcome measures

Measure	400 mcg Oxytocin IH n=7 Participants Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM n=5 Participants Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion n=2 Participants Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.	Non-Combined Oral Contraceptives+400 mcg Oxytocin IH n=5 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus n=1 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion n=5 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
Part 2: Absolute Values of Respiration Rate Pre dose, n=7,5,2,5,1,5	16.0 Breaths per minute Standard Deviation 1.63	15.8 Breaths per minute Standard Deviation 1.64	18.0 Breaths per minute Standard Deviation 1.41	14.8 Breaths per minute Standard Deviation 1.79	18.0 Breaths per minute Standard Deviation NA NA indicates that SD could not be calculated for a single participant	15.0 Breaths per minute Standard Deviation 2.00
Part 2: Absolute Values of Respiration Rate 5 minutes, n=7,4,2,5,1,5	15.4 Breaths per minute Standard Deviation 2.51	17.0 Breaths per minute Standard Deviation 2.16	17.0 Breaths per minute Standard Deviation 2.83	15.2 Breaths per minute Standard Deviation 1.30	14.0 Breaths per minute Standard Deviation NA NA indicates that SD could not be calculated for a single participant	16.8 Breaths per minute Standard Deviation 2.28
Part 2: Absolute Values of Respiration Rate 15 minutes, n=7,5,2,5,1,5	16.1 Breaths per minute Standard Deviation 1.86	15.6 Breaths per minute Standard Deviation 1.14	15.5 Breaths per minute Standard Deviation 0.71	15.4 Breaths per minute Standard Deviation 0.55	14.0 Breaths per minute Standard Deviation NA NA indicates that SD could not be calculated for a single participant	16.6 Breaths per minute Standard Deviation 2.70
Part 2: Absolute Values of Respiration Rate 30 minutes, n=7,5,2,5,1,5	15.6 Breaths per minute Standard Deviation 1.99	15.6 Breaths per minute Standard Deviation 1.82	14.5 Breaths per minute Standard Deviation 0.71	15.0 Breaths per minute Standard Deviation 1.87	14.0 Breaths per minute Standard Deviation NA NA indicates that SD could not be calculated for a single participant	15.6 Breaths per minute Standard Deviation 1.14
Part 2: Absolute Values of Respiration Rate 1 hour, n=7,5,2,5,1,5	15.4 Breaths per minute Standard Deviation 0.79	15.6 Breaths per minute Standard Deviation 1.14	15.0 Breaths per minute Standard Deviation 1.41	13.8 Breaths per minute Standard Deviation 2.05	14.0 Breaths per minute Standard Deviation NA NA indicates that SD could not be calculated for a single participant	15.6 Breaths per minute Standard Deviation 0.89
Part 2: Absolute Values of Respiration Rate 4 hours, n=7,5,2,5,1,5	16.0 Breaths per minute Standard Deviation 1.63	15.4 Breaths per minute Standard Deviation 1.34	17.5 Breaths per minute Standard Deviation 0.71	15.0 Breaths per minute Standard Deviation 2.00	15.0 Breaths per minute Standard Deviation NA NA indicates that SD could not be calculated for a single participant	15.6 Breaths per minute Standard Deviation 1.52

PRIMARY outcome

Timeframe: -1 hour,-30 minutes,-15 minutes pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose

Population: Pharmacokinetic Population. Only those participants with data available at specified data points were analyzed (represented by n=X in category titles). Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.

Blood samples were collected at indicated time points to evaluate concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	400 mcg Oxytocin IH n=7 Participants Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM n=5 Participants Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion n=2 Participants Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.	Non-Combined Oral Contraceptives+400 mcg Oxytocin IH n=5 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus n=1 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion n=5 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
Part 2: Plasma Concentration Time Profile of Oxytocin. 8 minutes; n=7, 2, 2, 5, 1, 4	145.500 Picograms per milliliter Interval 54.92 to 471.11	456.100 Picograms per milliliter Interval 415.88 to 496.32	554.120 Picograms per milliliter Interval 515.82 to 592.42	287.980 Picograms per milliliter Interval 173.56 to 507.98	507.620 Picograms per milliliter Interval 507.62 to 507.62	560.665 Picograms per milliliter Interval 522.35 to 899.48
Part 2: Plasma Concentration Time Profile of Oxytocin. 4 Hours; n=7, 4, 2, 5, 1, 4	0.000 Picograms per milliliter Interval 0.0 to 2.91	0.000 Picograms per milliliter Interval 0.0 to 13.36	0.000 Picograms per milliliter Interval 0.0 to 0.0	2.910 Picograms per milliliter Interval 0.0 to 4.43	0.000 Picograms per milliliter Interval 0.0 to 0.0	0.000 Picograms per milliliter Interval 0.0 to 0.0
Part 2: Plasma Concentration Time Profile of Oxytocin. -1 hour; n=7, 4, 2, 5, 1, 4	0.000 Picograms per milliliter Interval 0.0 to 0.0	0.000 Picograms per milliliter Interval 0.0 to 0.0	0.000 Picograms per milliliter Interval 0.0 to 0.0	0.000 Picograms per milliliter Interval 0.0 to 0.0	0.000 Picograms per milliliter Interval 0.0 to 0.0	0.000 Picograms per milliliter Interval 0.0 to 0.0
Part 2: Plasma Concentration Time Profile of Oxytocin. -30 minutes; n=7, 4, 2, 5, 1, 4	0.000 Picograms per milliliter Interval 0.0 to 0.0	0.000 Picograms per milliliter Interval 0.0 to 0.0	0.000 Picograms per milliliter Interval 0.0 to 0.0	0.000 Picograms per milliliter Interval 0.0 to 0.0	0.000 Picograms per milliliter Interval 0.0 to 0.0	0.000 Picograms per milliliter Interval 0.0 to 0.0
Part 2: Plasma Concentration Time Profile of Oxytocin. -15 minutes; n=7, 4, 2, 5, 1, 4	0.000 Picograms per milliliter Interval 0.0 to 0.0	0.000 Picograms per milliliter Interval 0.0 to 0.0	0.000 Picograms per milliliter Interval 0.0 to 0.0	0.000 Picograms per milliliter Interval 0.0 to 0.0	0.000 Picograms per milliliter Interval 0.0 to 0.0	0.000 Picograms per milliliter Interval 0.0 to 0.0
Part 2: Plasma Concentration Time Profile of Oxytocin. 2 minutes; n=7, 3, 2, 5, 1, 4	114.840 Picograms per milliliter Interval 31.71 to 418.11	1081.270 Picograms per milliliter Interval 954.86 to 1166.49	219.930 Picograms per milliliter Interval 36.96 to 402.9	274.840 Picograms per milliliter Interval 47.89 to 526.82	727.660 Picograms per milliliter Interval 727.66 to 727.66	284.160 Picograms per milliliter Interval 157.26 to 446.0
Part 2: Plasma Concentration Time Profile of Oxytocin. 3 minutes; n=7, 3, 2, 5, 1, 4	157.710 Picograms per milliliter Interval 50.71 to 664.51	1096.990 Picograms per milliliter Interval 910.9 to 1294.71	496.705 Picograms per milliliter Interval 349.05 to 644.36	345.610 Picograms per milliliter Interval 83.23 to 655.7	1312.740 Picograms per milliliter Interval 1312.74 to 1312.74	539.615 Picograms per milliliter Interval 440.78 to 1060.64
Part 2: Plasma Concentration Time Profile of Oxytocin. 5 minutes; n=7, 3, 2, 5, 1, 4	167.250 Picograms per milliliter Interval 57.34 to 551.96	627.240 Picograms per milliliter Interval 504.07 to 812.48	697.740 Picograms per milliliter Interval 697.69 to 697.79	364.740 Picograms per milliliter Interval 124.4 to 567.33	827.940 Picograms per milliliter Interval 827.94 to 827.94	622.175 Picograms per milliliter Interval 511.83 to 1309.51
Part 2: Plasma Concentration Time Profile of Oxytocin. 10 minutes; n=7, 4, 2, 5, 1, 4	142.900 Picograms per milliliter Interval 62.69 to 407.67	345.845 Picograms per milliliter Interval 205.24 to 410.44	422.745 Picograms per milliliter Interval 395.49 to 450.0	319.960 Picograms per milliliter Interval 189.58 to 416.07	431.980 Picograms per milliliter Interval 431.98 to 431.98	464.925 Picograms per milliliter Interval 417.84 to 584.43
Part 2: Plasma Concentration Time Profile of Oxytocin. 15 minutes; n=7, 4, 2, 5, 1, 4	131.970 Picograms per milliliter Interval 71.72 to 343.15	197.855 Picograms per milliliter Interval 157.07 to 206.02	228.795 Picograms per milliliter Interval 176.11 to 281.48	250.260 Picograms per milliliter Interval 173.25 to 366.23	266.140 Picograms per milliliter Interval 266.14 to 266.14	234.745 Picograms per milliliter Interval 213.78 to 290.64
Part 2: Plasma Concentration Time Profile of Oxytocin. 20 minutes; n=7, 4, 2, 5, 1, 4	128.510 Picograms per milliliter Interval 62.3 to 278.18	128.060 Picograms per milliliter Interval 94.91 to 139.29	146.675 Picograms per milliliter Interval 108.99 to 184.36	230.840 Picograms per milliliter Interval 163.7 to 290.43	159.500 Picograms per milliliter Interval 159.5 to 159.5	138.780 Picograms per milliliter Interval 130.76 to 176.35
Part 2: Plasma Concentration Time Profile of Oxytocin. 30 minutes; n=7, 4, 2, 5, 1, 4	100.500 Picograms per milliliter Interval 57.46 to 183.49	63.485 Picograms per milliliter Interval 50.3 to 74.87	75.630 Picograms per milliliter Interval 53.02 to 98.24	200.950 Picograms per milliliter Interval 130.12 to 211.65	80.120 Picograms per milliliter Interval 80.12 to 80.12	65.560 Picograms per milliliter Interval 60.35 to 82.21
Part 2: Plasma Concentration Time Profile of Oxytocin. 45 minutes; n=7, 4, 2, 5, 1, 4	54.400 Picograms per milliliter Interval 35.5 to 102.79	29.290 Picograms per milliliter Interval 21.05 to 32.88	34.125 Picograms per milliliter Interval 22.53 to 45.72	133.290 Picograms per milliliter Interval 91.63 to 163.78	39.220 Picograms per milliliter Interval 39.22 to 39.22	30.945 Picograms per milliliter Interval 21.41 to 33.89
Part 2: Plasma Concentration Time Profile of Oxytocin. 1 Hour; n=7, 4, 2, 5, 1, 4	32.980 Picograms per milliliter Interval 22.9 to 65.79	15.095 Picograms per milliliter Interval 11.32 to 21.81	22.145 Picograms per milliliter Interval 12.03 to 32.26	84.240 Picograms per milliliter Interval 65.27 to 112.31	21.290 Picograms per milliliter Interval 21.29 to 21.29	15.495 Picograms per milliliter Interval 14.69 to 19.35
Part 2: Plasma Concentration Time Profile of Oxytocin. 1.5 Hours; n=7, 4, 2, 5, 1, 4	16.180 Picograms per milliliter Interval 9.74 to 28.43	5.580 Picograms per milliliter Interval 4.09 to 1100.01	8.170 Picograms per milliliter Interval 4.74 to 11.6	41.270 Picograms per milliliter Interval 30.05 to 59.89	7.200 Picograms per milliliter Interval 7.2 to 7.2	5.160 Picograms per milliliter Interval 4.51 to 6.11
Part 2: Plasma Concentration Time Profile of Oxytocin. 2 Hours; n=7, 4, 2, 5, 1, 4	7.250 Picograms per milliliter Interval 3.66 to 15.4	2.885 Picograms per milliliter Interval 2.0 to 19.51	2.960 Picograms per milliliter Interval 0.0 to 5.92	19.770 Picograms per milliliter Interval 10.73 to 23.97	3.500 Picograms per milliliter Interval 3.5 to 3.5	2.460 Picograms per milliliter Interval 0.0 to 2.72
Part 2: Plasma Concentration Time Profile of Oxytocin. 2.5 Hours; n=7, 4, 2, 5, 1, 4	4.090 Picograms per milliliter Interval 0.0 to 8.86	0.000 Picograms per milliliter Interval 0.0 to 73.6	0.000 Picograms per milliliter Interval 0.0 to 0.0	9.640 Picograms per milliliter Interval 5.41 to 12.03	0.000 Picograms per milliliter Interval 0.0 to 0.0	0.000 Picograms per milliliter Interval 0.0 to 0.0
Part 2: Plasma Concentration Time Profile of Oxytocin. 3 Hours; n=7, 4, 2, 5, 1, 4	2.470 Picograms per milliliter Interval 0.0 to 5.33	0.000 Picograms per milliliter Interval 0.0 to 4.11	0.000 Picograms per milliliter Interval 0.0 to 0.0	5.740 Picograms per milliliter Interval 2.64 to 7.31	0.000 Picograms per milliliter Interval 0.0 to 0.0	0.000 Picograms per milliliter Interval 0.0 to 0.0

PRIMARY outcome

Timeframe: -1 hour,-30 minutes,-15 minutes pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose

Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed. Participants analysed (23) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.

Blood samples were collected at indicated time points to evaluate Cmax of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	400 mcg Oxytocin IH n=7 Participants Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM n=4 Participants Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion n=2 Participants Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.	Non-Combined Oral Contraceptives+400 mcg Oxytocin IH n=5 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus n=1 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion n=4 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
Part 2: Maximum Observed Plasma Concentration (Cmax) of Oxytocin	224.25 Picogram per milliliter Geometric Coefficient of Variation 92.5	838.25 Picogram per milliliter Geometric Coefficient of Variation 67.2	697.74 Picogram per milliliter Geometric Coefficient of Variation 0.0	357.38 Picogram per milliliter Geometric Coefficient of Variation 51.4	1312.74 Picogram per milliliter Geometric Coefficient of Variation NA NA indicates that Geometric Coefficient of Variation could not be calculated for a single participant	721.68 Picogram per milliliter Geometric Coefficient of Variation 42.2

PRIMARY outcome

Timeframe: 10 minutes post dose

Population: Pharmacokinetic Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.

Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	400 mcg Oxytocin IH n=7 Participants Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM n=5 Participants Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion n=2 Participants Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.	Non-Combined Oral Contraceptives+400 mcg Oxytocin IH n=5 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus n=1 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion n=5 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
Part 2: Observed Plasma Concentration (Cp)10 of Oxytocin	179.98 Picogram per milliliter Geometric Coefficient of Variation 79.6	293.00 Picogram per milliliter Geometric Coefficient of Variation 32.1	421.87 Picogram per milliliter Geometric Coefficient of Variation 9.1	292.95 Picogram per milliliter Geometric Coefficient of Variation 37.7	431.98 Picogram per milliliter Geometric Coefficient of Variation NA NA indicates that Geometric Coefficient of Variation could not be calculated for a single participant	407.99 Picogram per milliliter Geometric Coefficient of Variation 39.6

PRIMARY outcome

Timeframe: 20 minutes post dose

Population: Pharmacokinetic Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.

Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	400 mcg Oxytocin IH n=7 Participants Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM n=5 Participants Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion n=2 Participants Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.	Non-Combined Oral Contraceptives+400 mcg Oxytocin IH n=5 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus n=1 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion n=5 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
Part 2: Observed Plasma Concentration (Cp)20 of Oxytocin	131.72 Picogram per milliliter Geometric Coefficient of Variation 61.1	110.44 Picogram per milliliter Geometric Coefficient of Variation 26.0	141.75 Picogram per milliliter Geometric Coefficient of Variation 38.5	231.76 Picogram per milliliter Geometric Coefficient of Variation 22.2	159.50 Picogram per milliliter Geometric Coefficient of Variation NA NA indicates that Geometric Coefficient of Variation could not be calculated for a single participant	131.21 Picogram per milliliter Geometric Coefficient of Variation 25.8

PRIMARY outcome

Timeframe: 30 minutes post dose

Population: Pharmacokinetic Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.

Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	400 mcg Oxytocin IH n=7 Participants Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM n=5 Participants Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion n=2 Participants Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.	Non-Combined Oral Contraceptives+400 mcg Oxytocin IH n=5 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus n=1 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion n=5 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
Part 2: Observed Plasma Concentration (Cp)30 of Oxytocin	93.54 Picogram per milliliter Geometric Coefficient of Variation 49.6	56.70 Picogram per milliliter Geometric Coefficient of Variation 26.3	72.17 Picogram per milliliter Geometric Coefficient of Variation 45.8	184.71 Picogram per milliliter Geometric Coefficient of Variation 20.6	80.12 Picogram per milliliter Geometric Coefficient of Variation NA NA indicates that Geometric Coefficient of Variation could not be calculated for a single participant	63.02 Picogram per milliliter Geometric Coefficient of Variation 20.6

PRIMARY outcome

Timeframe: -1 hour,-30 minutes,-15 minutes pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose

Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed. Participants analysed (23) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.

Blood samples were collected at indicated time points to evaluate Tmax of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	400 mcg Oxytocin IH n=7 Participants Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM n=4 Participants Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion n=2 Participants Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.	Non-Combined Oral Contraceptives+400 mcg Oxytocin IH n=5 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus n=1 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion n=4 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
Part 2: Time to Reach Maximum Observed Concentration (Tmax) of Oxytocin	0.08333 Hours Interval 0.05 to 0.25	0.04167 Hours Interval 0.0333 to 0.1833	0.0833 Hours Interval 0.0833 to 0.0833	0.0833 Hours Interval 0.05 to 0.3333	0.05000 Hours Interval 0.05 to 0.05	0.08333 Hours Interval 0.0833 to 0.1333

PRIMARY outcome

Timeframe: -1 hour,-30 minutes,-15 minutes Pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose

Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed. Participants analysed (23) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.

Blood samples were collected at indicated time points to evaluate AUC (0-t) of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	400 mcg Oxytocin IH n=7 Participants Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM n=4 Participants Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion n=2 Participants Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.	Non-Combined Oral Contraceptives+400 mcg Oxytocin IH n=5 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus n=1 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion n=4 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
Part 2: Area Under the Concentration-time Curve From Time Zero Extrapolated to Time 't' (AUC[0-t]) of Oxytocin	127.58 Hour*picogram per milliliter Geometric Coefficient of Variation 58.6	161.39 Hour*picogram per milliliter Geometric Coefficient of Variation 44.1	164.46 Hour*picogram per milliliter Geometric Coefficient of Variation 15.8	247.42 Hour*picogram per milliliter Geometric Coefficient of Variation 22.3	208.37 Hour*picogram per milliliter Geometric Coefficient of Variation NA NA indicates that Geometric Coefficient of Variation could not be calculated for a single participant	171.21 Hour*picogram per milliliter Geometric Coefficient of Variation 23.9

PRIMARY outcome

Timeframe: -1 hour,-30 minutes,-15 minutes Pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose

Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed. Only IV reporting arms presented.

Blood samples were collected at indicated time points to evaluate plasma clearance of oxytocin IV bolus and infusion. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	400 mcg Oxytocin IH n=3 Participants Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM n=2 Participants Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion n=1 Participants Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.	Non-Combined Oral Contraceptives+400 mcg Oxytocin IH n=4 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
Part 2: Plasma Clearance (CL) of Oxytocin for IV Route Only	57.93 Liters per hour Geometric Coefficient of Variation 46.3	50.85 Liters per hour Geometric Coefficient of Variation 16.1	40.44 Liters per hour Geometric Coefficient of Variation NA NA indicates that Geometric Coefficient of Variation could not be calculated for a single participant	49.23 Liters per hour Geometric Coefficient of Variation 23.6	—	—

PRIMARY outcome

Timeframe: -1 hour,-30 minutes,-15 minutes Pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose

Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed. Only IV reporting arms presented.

Blood samples were collected at indicated time points to evaluate volume of distribution of oxytocin IV bolus and infusion. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	400 mcg Oxytocin IH n=3 Participants Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM n=2 Participants Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion n=1 Participants Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.	Non-Combined Oral Contraceptives+400 mcg Oxytocin IH n=4 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
Part 2: Volume of Distribution (VOD) of Oxytocin for IV Route Only	31.22 Liters Geometric Coefficient of Variation 56.5	25.50 Liters Geometric Coefficient of Variation 7.8	20.85 Liters Geometric Coefficient of Variation NA NA indicates that Geometric Coefficient of Variation could not be calculated for a single participant	23.47 Liters Geometric Coefficient of Variation 27.4	—	—

PRIMARY outcome

Timeframe: -1 hour,-30 minutes,-15 minutes pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose

Population: Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed. Participants analysed (22) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.

Blood samples were collected at indicated time points to evaluate t1/2 of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	400 mcg Oxytocin IH n=7 Participants Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM n=3 Participants Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion n=2 Participants Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.	Non-Combined Oral Contraceptives+400 mcg Oxytocin IH n=5 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus n=1 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion n=4 Participants Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
Part 2: Time to Reach Terminal Phase Half-life (t1/2) of Oxytocin	0.5523 Hours Interval 0.376 to 0.882	0.3728 Hours Interval 0.341 to 0.411	0.3525 Hours Interval 0.294 to 0.411	0.6154 Hours Interval 0.422 to 0.721	0.357 Hours Interval 0.357 to 0.357	0.3398 Hours Interval 0.26 to 0.398

SECONDARY outcome

Timeframe: Up to 15 days

Population: Safety Population includes participants who received at least one dose of study medication

An adverse event is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function.

Outcome measures

Measure	400 mcg Oxytocin IH n=9 Participants Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM n=8 Participants Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.	Non-Combined Oral Contraceptives+400 mcg Oxytocin IH Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
Part 1: Number of Participants With Non-SAEs and SAEs Any non-SAE	3 Participants	2 Participants	—	—	—	—
Part 1: Number of Participants With Non-SAEs and SAEs Any SAE	2 Participants	2 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 30 minutes and 2 hours post dose

Population: Safety Population. Only those participants with data available at specified data points were analyzed (represented by n= X in the category titles).

Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest.

Outcome measures

Measure	400 mcg Oxytocin IH n=9 Participants Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM n=8 Participants Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.	Non-Combined Oral Contraceptives+400 mcg Oxytocin IH Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
Part 1: Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP: 30 minutes; n=9, 8	114.2 Millimeters of mercury Standard Deviation 10.35	121.5 Millimeters of mercury Standard Deviation 19.65	—	—	—	—
Part 1: Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP: 2 hours; n=9, 7	111.0 Millimeters of mercury Standard Deviation 16.63	110.0 Millimeters of mercury Standard Deviation 10.21	—	—	—	—
Part 1: Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP: 30 minutes; n=9, 8	66.2 Millimeters of mercury Standard Deviation 5.31	69.9 Millimeters of mercury Standard Deviation 11.37	—	—	—	—
Part 1: Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP: 2 hours; n=9, 7	65.1 Millimeters of mercury Standard Deviation 8.48	64.0 Millimeters of mercury Standard Deviation 9.04	—	—	—	—

SECONDARY outcome

Timeframe: 30 minutes and 2 hours post dose

Population: Safety Population. Only those participants with data available at specified data points were analyzed (represented by n= X in the category titles).

Heart rate was measured in semi-supine position after 5 minutes rest

Outcome measures

Measure	400 mcg Oxytocin IH n=9 Participants Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM n=8 Participants Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.	Non-Combined Oral Contraceptives+400 mcg Oxytocin IH Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
Part 1: Absolute Values of Heart Rate 30 minutes; n= 9, 8	86.9 Beats per minute Standard Deviation 19.85	86.4 Beats per minute Standard Deviation 23.05	—	—	—	—
Part 1: Absolute Values of Heart Rate 2 hours; n= 9, 7	86.0 Beats per minute Standard Deviation 16.89	83.0 Beats per minute Standard Deviation 11.27	—	—	—	—

SECONDARY outcome

Timeframe: 30 minutes and 2 hours post dose

Population: Safety Population. Only those participants with data available at specified data points were analyzed.

Respiration rate was measured in semi-supine position after 5 minutes rest

Outcome measures

Measure	400 mcg Oxytocin IH n=9 Participants Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM n=7 Participants Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.	Non-Combined Oral Contraceptives+400 mcg Oxytocin IH Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
Part 1: Absolute Values of Respiration Rate 30 minutes	14.4 Breaths per minute Standard Deviation 2.55	14.6 Breaths per minute Standard Deviation 3.15	—	—	—	—
Part 1: Absolute Values of Respiration Rate 2 hours	14.7 Breaths per minute Standard Deviation 2.06	14.1 Breaths per minute Standard Deviation 2.19	—	—	—	—

SECONDARY outcome

Timeframe: 30 minutes and 2 hours post dose

Population: Safety Population. Only those participants with data available at specified data points were analyzed.

Body temperature was measured in semi-supine position after 5 minutes rest

Outcome measures

Measure	400 mcg Oxytocin IH n=9 Participants Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM n=7 Participants Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.	Non-Combined Oral Contraceptives+400 mcg Oxytocin IH Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
Part 1: Absolute Values of Temperature 2 hours	37.03 Degrees Celsius Standard Deviation 0.581	36.90 Degrees Celsius Standard Deviation 0.173	—	—	—	—
Part 1: Absolute Values of Temperature 30 minutes	37.29 Degrees Celsius Standard Deviation 0.699	36.69 Degrees Celsius Standard Deviation 0.135	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1, pre-dose), 30 minutes and 2 hours post dose

Population: Safety Population. Only those participants with data available at specified data points were analyzed (represented by n= X in the category titles).

SBP and DBP of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

Outcome measures

Measure	400 mcg Oxytocin IH n=9 Participants Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM n=8 Participants Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.	Non-Combined Oral Contraceptives+400 mcg Oxytocin IH Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
Part 1: Change From Baseline in SBP and DBP SBP: 30 minutes; n= 9, 8	0.1 Millimeters of mercury Standard Deviation 8.39	11.4 Millimeters of mercury Standard Deviation 17.48	—	—	—	—
Part 1: Change From Baseline in SBP and DBP SBP: 2 hours; n=9, 7	-3.1 Millimeters of mercury Standard Deviation 13.27	-0.9 Millimeters of mercury Standard Deviation 13.21	—	—	—	—
Part 1: Change From Baseline in SBP and DBP DBP: 30 minutes; n= 9, 8	-4.0 Millimeters of mercury Standard Deviation 11.14	-0.1 Millimeters of mercury Standard Deviation 13.17	—	—	—	—
Part 1: Change From Baseline in SBP and DBP DBP: 2 hours; n=9, 7	-5.1 Millimeters of mercury Standard Deviation 10.43	-6.0 Millimeters of mercury Standard Deviation 11.47	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1, pre-dose), 30 minutes and 2 hours post dose

Population: Safety Population. Only those participants with data available at specified data points were analyzed (represented by n= X in the category titles).

Heart rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

Outcome measures

Measure	400 mcg Oxytocin IH n=9 Participants Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM n=8 Participants Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.	Non-Combined Oral Contraceptives+400 mcg Oxytocin IH Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
Part 1: Change From Baseline in Heart Rate 30 minutes; n= 9, 8	0.2 Beats per minute Standard Deviation 16.41	4.8 Beats per minute Standard Deviation 22.75	—	—	—	—
Part 1: Change From Baseline in Heart Rate 2 hours; n=9, 7	-0.7 Beats per minute Standard Deviation 10.39	1.9 Beats per minute Standard Deviation 9.81	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1, pre-dose), 30 minutes and 2 hours post dose

Population: Safety Population. Only those participants with data available at specified data points were analyzed.

Respiration rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

Outcome measures

Measure	400 mcg Oxytocin IH n=9 Participants Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM n=7 Participants Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.	Non-Combined Oral Contraceptives+400 mcg Oxytocin IH Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
Part 1: Change From Baseline in Respiration Rate 30 minutes	0.3 Breaths per minute Standard Deviation 2.12	-0.3 Breaths per minute Standard Deviation 2.75	—	—	—	—
Part 1: Change From Baseline in Respiration Rate 2 hours	0.6 Breaths per minute Standard Deviation 2.24	-0.7 Breaths per minute Standard Deviation 1.89	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1, pre-dose), 30 minutes and 2 hours post dose

Population: Safety Population. Only those participants with data available at specified data points were analyzed.

Body temperature was measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

Outcome measures

Measure	400 mcg Oxytocin IH n=9 Participants Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM n=7 Participants Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.	Non-Combined Oral Contraceptives+400 mcg Oxytocin IH Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
Part 1: Change From Baseline in Body Temperature 30 minutes	0.60 Degrees Celsius Standard Deviation 0.740	-0.01 Degrees Celsius Standard Deviation 0.434	—	—	—	—
Part 1: Change From Baseline in Body Temperature 2 hours	0.34 Degrees Celsius Standard Deviation 0.623	0.20 Degrees Celsius Standard Deviation 0.277	—	—	—	—

SECONDARY outcome

Timeframe: Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours and 3 hours post dose on Day 1

Population: Pharmacokinetic Population.

Blood samples were collected at indicated time points to evaluate AUC (0-3) of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.

Outcome measures

Measure	400 mcg Oxytocin IH n=9 Participants Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM n=8 Participants Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.	Non-Combined Oral Contraceptives+400 mcg Oxytocin IH Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Three Hours (AUC ([0-3]) of Oxytocin	NA Hour*picogram per milliliter Standard Deviation NA NA indicates that data could not be calculated as all values at specified time points (up to 3 hours post-dose) were below the limit of quantification.	NA Hour*picogram per milliliter Standard Deviation NA NA indicates that data could not be calculated as all values at specified time points (up to 3 hours post-dose) were below the limit of quantification.	—	—	—	—

Adverse Events

400 mcg Oxytocin IH

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

17 mcg Oxytocin IM

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Combined Oral Contraceptives+400 mcg Oxytocin IH

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Non-Combined Oral Contraceptives+400 mcg Oxytocin IH

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	400 mcg Oxytocin IH n=9 participants at risk Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labor (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM n=8 participants at risk Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Combined Oral Contraceptives+400 mcg Oxytocin IH n=7 participants at risk Healthy participants of childbearing potential receiving oral contraceptive along with 400 mcg oxytocin IH	Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus n=5 participants at risk Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.	Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion n=2 participants at risk Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.	Non-Combined Oral Contraceptives+400 mcg Oxytocin IH n=5 participants at risk Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus n=1 participants at risk Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion n=5 participants at risk Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
General disorders Pyrexia	22.2% 2/9 • Number of events 2 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/8 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/7 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/2 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/1 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.
Blood and lymphatic system disorders Anaemia	0.00% 0/9 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	12.5% 1/8 • Number of events 1 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/7 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/2 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/1 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.
Pregnancy, puerperium and perinatal conditions Postpartum haemorrhage	0.00% 0/9 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	12.5% 1/8 • Number of events 1 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/7 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/2 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/1 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.

Other adverse events

Measure	400 mcg Oxytocin IH n=9 participants at risk Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labor (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	17 mcg Oxytocin IM n=8 participants at risk Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.	Combined Oral Contraceptives+400 mcg Oxytocin IH n=7 participants at risk Healthy participants of childbearing potential receiving oral contraceptive along with 400 mcg oxytocin IH	Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus n=5 participants at risk Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.	Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion n=2 participants at risk Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.	Non-Combined Oral Contraceptives+400 mcg Oxytocin IH n=5 participants at risk Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus n=1 participants at risk Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.	Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion n=5 participants at risk Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.
Blood and lymphatic system disorders Anaemia	11.1% 1/9 • Number of events 1 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	12.5% 1/8 • Number of events 1 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/7 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/2 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/1 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.
Nervous system disorders Headache	0.00% 0/9 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/8 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	57.1% 4/7 • Number of events 5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	80.0% 4/5 • Number of events 5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/2 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	40.0% 2/5 • Number of events 2 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/1 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	80.0% 4/5 • Number of events 5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.
Vascular disorders Flushing	0.00% 0/9 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/8 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/7 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	40.0% 2/5 • Number of events 2 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/2 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/1 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	20.0% 1/5 • Number of events 1 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.
Vascular disorders Hot flush	0.00% 0/9 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/8 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	28.6% 2/7 • Number of events 2 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	50.0% 1/2 • Number of events 1 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	20.0% 1/5 • Number of events 1 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/1 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	40.0% 2/5 • Number of events 2 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.
Cardiac disorders Sinus tachycardia	0.00% 0/9 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/8 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/7 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	40.0% 2/5 • Number of events 2 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/2 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/1 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.
General disorders Feeling hot	0.00% 0/9 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/8 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	14.3% 1/7 • Number of events 1 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	20.0% 1/5 • Number of events 1 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/2 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	40.0% 2/5 • Number of events 2 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	100.0% 1/1 • Number of events 1 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	40.0% 2/5 • Number of events 2 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.
Infections and infestations Nasopharyngitis	0.00% 0/9 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/8 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	28.6% 2/7 • Number of events 3 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/2 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/1 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.
Investigations Electrocardiogram QT prolonged	0.00% 0/9 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/8 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/7 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	40.0% 2/5 • Number of events 2 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/2 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/1 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	20.0% 1/5 • Number of events 1 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/9 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/8 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	28.6% 2/7 • Number of events 2 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	20.0% 1/5 • Number of events 1 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/2 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	20.0% 1/5 • Number of events 1 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/1 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.
Cardiac disorders Palpitations	0.00% 0/9 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/8 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/7 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/2 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/1 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	40.0% 2/5 • Number of events 2 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.
General disorders Pyrexia	0.00% 0/9 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	12.5% 1/8 • Number of events 1 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/7 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/2 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/1 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.
Infections and infestations Nipple infection	11.1% 1/9 • Number of events 1 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/8 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/7 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/2 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/1 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.
Injury, poisoning and procedural complications Perineal injury	11.1% 1/9 • Number of events 1 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/8 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/7 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/2 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/1 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/9 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	12.5% 1/8 • Number of events 1 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/7 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/2 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/1 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.
Pregnancy, puerperium and perinatal conditions Postpartum haemorrhage	11.1% 1/9 • Number of events 1 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/8 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/7 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/2 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/1 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.
Vascular disorders Hypertension	0.00% 0/9 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	12.5% 1/8 • Number of events 1 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/7 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/2 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/1 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.	0.00% 0/5 • All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2. Non-SAEs and SAEs are reported for Safety Population.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: GSKClinicalSupportHD@gsk.com

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER