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Retosiban for Infusion

Phase 1

Obstetric Labour, Premature | Small molecule | Other |GSK plc|Last Updated: May 9, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02377414Study to Investigate the Pharmacokinetics (PK), Safety and Tolerability of Retosiban in Healthy Japanese WomenPHASE1 COMPLETED 32 — — Mar 2, 2015Apr 17, 2015May 9, 20171 United States
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Study Endpoints
Primary Endpoints
Composite of PK parameters of retosiban administered by intravenous infusion to healthy adult Japanese and Caucasian women of child-bearing potential: AUC, Cmax, t1/2 and clearance of retosiban
Pre-dose, 0.5 h, 1 h, 2 h, 4 h, 8 h, 12 h, 18 h, 24 h (just before dose increase), 24.5 h, 25 h, 26 h, 28 h, 36 h, 42 h, 48 h, 48.5 h, 49 h, 50 h, 52 h, 54 h, 56 h and 60 h post start of the infusion

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

Composite of PK parameters of retosiban and its major inactive metabolite (GSK2847065) in healthy adult Japanese and Caucasian women of child-bearing potential: AUC, Cmax, t1/2
Pre-dose, 0.5 h, 1 h, 2 h, 4 h, 8 h, 12 h, 18 h, 24 h (just before dose increase), 24.5 h, 25 h, 26 h, 28 h, 36 h, 42 h, 48 h, 48.5 h, 49 h, 50 h, 52 h, 54 h, 56 h and 60 h post start of the infusion

AUC, Cmax, t1/2

Secondary Endpoints
Number of subjects with adverse events (AEs) and serious adverse events (SAEs)
Up to 13 days
Composite of clinical laboratory assessments
Up to 13 days
Vital sign assessment as a measure of safety
Up to 13 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1: Retosiban/placeboEXPERIMENTALEach 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: RetosibanEXPERIMENTALEach 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.
Interventions
NameTypeDescription
Retosiban solution for InfusionDRUGRetosiban 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
PlaceboDRUGPlacebo will be supplied as a clear, colorless IV solution for infusion with a unit dose strength of 0.9% sodium chloride (NaCl) normal saline
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Eligibility Criteria
Age Range20 Years — 45 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

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...

Countries:United States
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