Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
oxytocin · 1 trial · 1 indication
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Hematology assessments will be performed for the following parameters: platelet count, red blood cell (RBC) count, hemoglobin, hematocrit, white blood cells (WBC) (absolute), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), neutrophils, lymphocytes, monocytes, eosinophils, and basophils.
Clinical chemistry assessments will be performed for the following parameters: blood urea nitrogen (BUN), creatinine, glucose, potassium, sodium, calcium, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total and direct bilirubin, total protein, and albumin.
Dipstick method will be used to measure pH, glucose, protein, blood and ketones.
Three readings of blood pressure will be taken at screening (single readings at all other time-points).
Three readings of pulse rate will be taken at screening (single readings at all other time-points).
Absolute values and changes over time of heart rate from pre-dose values as a measure of safety and tolerability.
Triplicate 12-lead ECGs will be obtained screening and predose (predose IM oxytocin), and single 12-lead ECGs at all other time-points during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals.
FEV1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. Pulse oximetry is a procedure used to measure the oxygen level (or oxygen saturation) in the blood.
Blood samples will be withdrawn from subjects at pre dose, 3 minutes (mins), 5 mins, 10 mins, 20 mins, 0.5h, 0.75h, 1 hour (h), 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 8 h, and 24 h (24 h post dose assessments only applicable to Dosing Session 1, Group 1 and the first 3 subjects at each new dose level \[Dosing Sessions 2 -4\]).
Blood samples will be withdrawn from subjects at pre dose, 3 mins, 5 mins, 10 mins, 20 mins, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, and 8 h.
Blood samples will be withdrawn from subjects at pre dose, 3 mins, 5 mins, 10 mins, 20 mins, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 8 h, and 24 h (24 h post dose assessments only applicable to Dosing Session 1, Group 1 and the first 3 subjects at each new dose level \[Dosing Sessions 2 -4\]).
Blood samples will be withdrawn from subjects at pre dose, 3 mins, 5 mins, 10 mins, 20 mins, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, and 8 h.
| Arm | Type | Description |
|---|---|---|
| IM oxytocin - IH placebo/IH oxytocin (50, 200, 400, 600) | EXPERIMENTAL | Subjects will receive IM oxytocin, IH placebo/IH oxytocin at doses of 50, 200, 400, 600 mcg. |
| IM oxytocin - IH placebo/IH oxytocin (50) | EXPERIMENTAL | Subjects will receive IM oxytocin and IH placebo and/or IH oxytocin at 50 mcg. |
| Name | Type | Description |
|---|---|---|
| IM oxytocin 10 IU | DRUG | 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 |
| IH oxytocin 50 mcg | DRUG | 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. |
| IH oxytocin 200 mcg | DRUG | 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. |
| IH oxytocin 400 mcg | DRUG | 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. |
| IH oxytocin 600 mcg | DRUG | 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. |
| Placebo | DRUG | Placebo is a powder blend for inhalation in a hard capsule containing five inactive components, which is administered by oral inhalation. |
Inclusion Criteria: * Between 18 and 45 years of age inclusive, at the time of signing the informed consent. * Premenopausal women on an oestrogen-containing oral contraceptive pill (OCP) for a 12 month minimum period and to continue their current OCP schedule for the duration of the clinical study...
Oxytocin is being developed for the prevention or treatment of postpartum hemorrhage, a condition of heavy bleeding after childbirth. The program described here is an inhaled formulation of oxytocin studied in healthy female volunteers. It is an investigational product in clinical development and is not described as approved for this use.
Oxytocin targets OXTR, the oxytocin receptor, and acts as an agonist at that receptor. Agonist activity at OXTR is the mechanism underlying the drug's intended effect in postpartum hemorrhage. The candidate described here is a small molecule formulation of oxytocin developed by GSK.
GSK plc, which trades under the ticker GSK, is the developer of this oxytocin program. The inhaled oxytocin candidate is referred to in company materials as GR121619. GSK is a global pharmaceutical company, and this asset sits within its hematology pipeline for postpartum hemorrhage.
Oxytocin in this inhaled formulation is in Phase 1 development. The single listed trial was a Phase 1 study, and it has been completed. Because the program remains in early clinical development, it is investigational and has not been described as FDA approved for postpartum hemorrhage.
One trial is listed for this oxytocin program: NCT02542813, titled a safety, tolerability and pharmacokinetics study of oxytocin (GR121619) administered via an inhaled route in healthy female volunteers. It was a completed Phase 1 trial with 16 enrolled participants, conducted in the United Kingdom, and it enrolled healthy female volunteers aged 18 years and older.