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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

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

LYBALVI · 1 trial · 1 indication

Phase 1 1
NCT05547100Study of the Breast Milk Pharmacokinetics of Olanzapine and SamidorphanFocus of Study is on Healthy Lactating Women
COMPLETED12 Analytics
PHASE1COMPLETED
Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan
Focus of Study is on Healthy Lactating Women
NCT0554710012
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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 to 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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Frequently asked questions about LYBALVI

What is LYBALVI?

LYBALVI is a small molecule drug being developed by Alkermes plc. It is currently in Phase 1 clinical development. The focus of the study is on healthy lactating women, and the drug is being investigated for its presence in breast milk.

What does LYBALVI target?

LYBALVI is a small molecule drug. The specific molecular target or target class has not been disclosed in the available information. The ongoing clinical study focuses on the breast milk pharmacokinetics of olanzapine and samidorphan, which are components of LYBALVI.

Who makes LYBALVI?

LYBALVI is being developed by Alkermes plc, a biopharmaceutical company. Alkermes is publicly traded under the ticker symbol ALKS on the stock market.

What phase is LYBALVI in?

LYBALVI is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The drug is still in the early stages of clinical testing.

What clinical trials is LYBALVI in?

LYBALVI has one completed Phase 1 clinical trial with the identifier NCT05547100. The study, titled 'Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan', enrolled 12 healthy lactating women in the United States. The trial was uncontrolled and not randomized or double-blinded.

Is LYBALVI the same as olanzapine and samidorphan?

LYBALVI contains the components olanzapine and samidorphan. The completed clinical trial studied the breast milk pharmacokinetics of these two components. LYBALVI is the brand name for the combination of these drugs.