Safety, Tolerability and Pharmacokinetics (PK) Study of Oxytocin (GR121619) Administered Via an Inhaled Route in Healthy Female Volunteers

What Was Tested

The trial (phase 1) is built around Oxytocin.

Intramuscular (IM) oxytocin is the gold standard prophylactic therapy for post partum haemorrhage (PPH).

It had two arms (groups): IM oxytocin - IH placebo/IH oxytocin (50, 200, 400, 600) (experimental) and IM oxytocin - IH placebo/IH oxytocin (50) (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 16 actual participants took part.

It was open to women only aged from 18 years up to 45 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Between 18 and 45 years of age inclusive, at the time of signing the informed consent. Physically capable of using an oral inhalation dry powder inhaler (DPI) device without physical assistance. FEV1.0 within normal range at screening.

The full record lists 5 inclusion and 27 exclusion criteria; among the exclusions: body mass index (bmi) within the range 18 - 30 kilogram (kg)/square meter (m\^2) (inclusive); postmenopausal female as defined by gynaecological history; chronic lung condition of any aetiology including adult asthma, chronic obstructive pulmonary disease (copd), emphysema and interstitial lung diseases.

How the Study Was Run

The set-up was randomized, factorial and single-blind.

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In this single-blind Oxytocin study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2015-09-14 with completion listed for 2015-12-16.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of subjects with adverse events (AEs) (time frame: Up to 16 weeks). Number of subjects with adverse respiratory events as monitored by spirometry including forced expiratory volume in 1 second (FEV1.0) and pulse oximetry as a measure of specific respiratory safety (time frame: Up to 16 weeks). Plasma concentration profile for IH oxytocin.

It also tracked 1 secondary outcome, for example Composite of PK parameters: Cmax and AUC will be compared as data permit.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Oxytocin in 16 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.