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LYBALVI

Phase 1

Focus of Study is on Healthy Lactating Women | Small molecule | Other |Alkermes plc|Last Updated: Feb 10, 2023

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
UNCONTROLLED
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05547100Study of the Breast Milk Pharmacokinetics of Olanzapine and SamidorphanPHASE1 COMPLETED 12 — — Sep 14, 2022Nov 19, 2022Feb 10, 20231 United States
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Study Endpoints
Primary Endpoints
Area under the concentration-time curve from time zero to 48 hours post-dose (AUC0 48)
Up to 15 days
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Up to 15 days
Area under the concentration-time curve from time zero to infinity (AUC∞)
Up to 15 days
\Maximum observed concentration (Cmax)
Up to 15 days
Time to reach Cmax (tmax)
Up to 15 days
Terminal half-life (t½)
Up to 15 days
Secondary Endpoints
Total amount of drug excreted in milk (milligrams)
Up to 15 days
Relative drug excreted in milk to dose percentage
Up to 15 days
Estimated infant dose (mg/kg)
Up to 15 days
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
5mg OLZAPINE /10mg SAMIDORPHANEXPERIMENTALOpen label, single dose 5mg OLZ/10 mg SAM
Interventions
NameTypeDescription
LYBALVIDRUG5 mg Olanzapine/10 mg Samidorphan dose approved for use in treatment for schizophrenia and bipolar I disorder
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Eligibility Criteria
Age Range18 Years — 45 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Body mass index ≥18 and \<35 kg/m2 * Subject is lactating, at least 4 weeks post-partum at dosing, and is using or willing to use an electronic breast pump for sample collection * Subject is willing to temporarily discontinue breastfeeding for the duration of at least 11 days ...

Countries:United States
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