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

PHASE1CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

September 14, 2015

Primary Completion Date

December 16, 2015

Study Completion Date

December 16, 2015

Conditions
Postpartum Hemorrhage
Interventions
DRUG

IM oxytocin 10 IU

IM oxytocin 10 IU is a colourless and clear sterile solution in a 1 mL ampoule containing 10 IU of oxytocin, which is administered intramuscularly

DRUG

IH oxytocin 50 mcg

IH oxytocin 50 mcg is a powder blend for inhalation in a hard capsule containing 50 mcg of oxytocin, which is administered by oral inhalation.

DRUG

IH oxytocin 200 mcg

IH oxytocin 200 mcg is a powder blend for inhalation in a hard capsule containing 200 mcg of oxytocin, which is administered by oral inhalation.

DRUG

IH oxytocin 400 mcg

IH oxytocin 400 mcg is a powder blend for inhalation in a hard capsule containing 400 mcg of oxytocin, which is administered by oral inhalation.

DRUG

IH oxytocin 600 mcg

IH oxytocin 600 mcg is a powder blend for inhalation in a hard capsule containing 600 mcg of oxytocin, which is administered by oral inhalation.

DRUG

Placebo

Placebo is a powder blend for inhalation in a hard capsule containing five inactive components, which is administered by oral inhalation.

Trial Locations (1)

CB2 2GG

GSK Investigational Site, Cambridge

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT02542813 - Safety, Tolerability and Pharmacokinetics (PK) Study of Oxytocin (GR121619) Administered Via an Inhaled Route in Healthy Female Volunteers | Biotech Hunter | Biotech Hunter