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Also known as Retosiban solution for Infusion
Retosiban for Infusion · 1 trial · 1 indication
PK parameters will include: area under concentration-time curve (AUC), maximum observed concentration (Cmax), terminal phase half-life (t1/2) and clearance (CL) of retosiban
AUC, Cmax, t1/2
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Retosiban/placebo | EXPERIMENTAL | Each subject in cohort 1 will receive an intravenous (IV) bolus infusion of 6 milligrams (mg) retosiban or placebo over 5 minutes, followed by a continuous infusion of 6 milligram per hour (mg/h) retosiban or placebo for 24 h. At 24 h of dosing, an additional 6 mg retosiban or placebo will be administered over 5 minutes followed by a 12 mg/h infusion over the next 24 h, for a total time of infusion of 48 h. Subjects administered with placebo will receive an equal volume of normal saline as an IV bolus as well as an equal rate of continuous infusion of normal saline as of retosiban. |
| Cohort 2: Retosiban | EXPERIMENTAL | Each subject in cohort 2 will receive a bolus infusion of 6 mg retosiban over 5 minutes, followed by a continuous infusion of 6 mg/h retosiban for 24 h. At 24 h of dosing, an additional 6 mg retosiban will be administered over 5 minutes followed by a 12 mg/h infusion over the next 24 h, for a total time of infusion of 48 h. |
| Name | Type | Description |
|---|---|---|
| Retosiban solution for Infusion | DRUG | Retosiban will be supplied as clear, colorless IV solution for infusion in 5 mL vial with a unit dose strength of 15 milligrams per milliliter (mg/mL) (each 5 mL vial contains 75 mg retosiban), dosed at up to 300 mg over 48 h infusion |
| Placebo | DRUG | Placebo will be supplied as a clear, colorless IV solution for infusion with a unit dose strength of 0.9% sodium chloride (NaCl) normal saline |
Inclusion Criteria: * Subjects who are between 20 and 45 years and of age, inclusive at the time of signing the informed consent form. * Japanese, defined as being born in Japan, having four ethnic Japanese grandparents, holding a Japanese passport or identity papers and being able to speak Japanes...
Retosiban for Infusion is an investigational small molecule developed by GSK plc for the management of premature obstetric labour. It is a Phase 1 clinical candidate and has not been approved for marketing. The compound is also referred to as Retosiban solution for Infusion.
Retosiban for Infusion is being studied for premature obstetric labour, a condition involving the onset of labour before term. The program is in Phase 1 development, so the drug is investigational and is not yet available as a treatment outside of clinical research.
Retosiban for Infusion targets OXTR, the oxytocin receptor. It acts as an antagonist at this receptor, meaning it blocks receptor signaling rather than activating it. This target class is relevant to uterine contractility, which underlies its study in premature obstetric labour.
Retosiban for Infusion is being developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program evaluating the compound in premature obstetric labour.
Retosiban for Infusion is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulator. The program has one completed Phase 1 trial and no active trials at this time.
Retosiban for Infusion has been evaluated in one completed Phase 1 trial, NCT02377414, titled Study to Investigate the Pharmacokinetics (PK), Safety and Tolerability of Retosiban in Healthy Japanese Women. The randomized, double-blind, controlled study enrolled 32 healthy female volunteers aged 20 years and older in the United States.
Yes, Retosiban for Infusion and Retosiban solution for Infusion refer to the same investigational product from GSK plc. The two names describe the same small molecule formulation studied in premature obstetric labour, so readers searching either term are looking at the same asset.