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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 being developed for the treatment of premature obstetric labour. It is intended to address preterm labour, a condition where contractions begin before the full term of pregnancy. The drug is currently in clinical development and has not been approved for use.
Retosiban for Infusion is being developed by GSK plc, a global pharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety, tolerability, and pharmacokinetics in the target population.
Retosiban for Infusion is in Phase 1 of clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and pharmacological properties in humans.
Retosiban for Infusion has one completed clinical trial, NCT02377414, which investigated its pharmacokinetics, safety, and tolerability in healthy Japanese women. The study enrolled 32 participants and was conducted in the United States. It was a randomized, double-blind, controlled trial.
Retosiban for Infusion is a formulation of the drug retosiban, specifically designed for intravenous administration. The term 'for Infusion' indicates the route of delivery, distinguishing it from other potential formulations. The active ingredient remains retosiban, and the drug is being studied for the same indication.