NCT02542813

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

Completed Phase 1 Last updated 19 October 2017

What this trial tests

Phase 1 trial testing IM oxytocin 10 IU in Postpartum Hemorrhage in 16 participants. Completed in 16 December 2015.

Timeline

14 September 2015

Primary endpoint
16 December 2015

16 December 2015

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	single
Primary purpose	treatment
Enrollment	16
Start date	14 September 2015
Primary completion	16 December 2015
Estimated completion	16 December 2015
Sites	1 location across United Kingdom

Drugs / interventions tested

• IM oxytocin 10 IU — full drug profile →
• IH oxytocin 50 mcg — full drug profile →
• IH oxytocin 200 mcg — full drug profile →
• IH oxytocin 400 mcg — full drug profile →
• IH oxytocin 600 mcg — full drug profile →
• Placebo

Conditions studied

• Postpartum Hemorrhage — all drugs for Postpartum Hemorrhage →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 45, female only, with Postpartum Hemorrhage. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Intramuscular (IM) oxytocin is the gold standard prophylactic therapy for post partum haemorrhage (PPH). However, in resource-poor settings within the developing world, the stability and therefore effectiveness of prophylactic IM oxytocin is diminished by a lack of appropriate refrigeration facilities and availability of trained health care professionals (HCPs) to administer IM injections. This study will be the first investigation of oxytocin in humans via the inhaled (IH) route and is designed to evaluate the safety and tolerability of inhaled oxytocin and the five non-pharmacologically active components in the placebo, and to establish the PK characteristics of up to four fixed escalating doses of inhaled oxytocin. In this single blind ascending dose-escalation study, the systemic exposure from up to four proposed escalating inhaled fixed-dose levels (50 micrograms \[mcg\], 200 mcg, 400 mcg and 600 mcg) will be compared with the systemic exposure following 10 international units (IU) of IM oxytocin in healthy premenopausal females.. A total of 15 subjects will be enrolled after screening sufficient number of healthy female subjects and the subjects will be assigned to one of the two treatment sequences. The total duration of this study is approximately 20 weeks.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Safety, Tolerability and Pharmacokinetics of Single Doses of Oxytocin Administered via an Inhaled Route in Healthy Females: Randomized, Single-blind, Phase 1 Study.
   Fernando D, Siederer S, Singh S, Schneider I, et al · · 2017 · cited 14× · PMID 28781129 · DOI 10.1016/j.ebiom.2017.07.020