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Atypical Antipsychotic

LYBALVI for Healthy Lactating Women

Phase 1
Waitlist Available
Research Sponsored by Alkermes, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 days
Awards & highlights

Study Summary

This trial is to study the amount of a drug that passes into breastmilk, and how much an infant is exposed to when they breastfeed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the concentration-time curve from time zero to 48 hours post-dose (AUC0 48)
Area under the concentration-time curve from time zero to infinity (AUC∞)
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
+3 more
Secondary outcome measures
Estimated infant dose (mg/kg)
Estimated relative infant dose to the weight-adjusted maternal dose (%)
Incidence of adverse events
+2 more

Side effects data

From 2016 Phase 4 trial • 8 Patients • NCT01833897
38%
sedation
25%
headache
13%
phosphenes
13%
hypomania
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ketamine and DCS Treatment

Trial Design

1Treatment groups
Experimental Treatment
Group I: 5mg OLZAPINE /10mg SAMIDORPHANExperimental Treatment1 Intervention
Open label, single dose 5mg OLZ/10 mg SAM

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Alkermes, Inc.Lead Sponsor
114 Previous Clinical Trials
26,804 Total Patients Enrolled
Sergey Yagoda, MD, PhDStudy DirectorAlkermes, Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this clinical experiment still accessible?

"Clinicaltrials.gov confirms that the trial, which debuted on September 14th 2022, is actively recruiting patients and has recently been updated on October 7th 2022."

Answered by AI

What criteria must be met in order to participate in this research?

"To be eligible to join, participants of this clinical trial must be lactating women between the ages 18 and 45 years old. Currently, 12 patients are being enrolled into the study."

Answered by AI

Do participants need to exceed a certain age threshold in order to be considered for this trial?

"This trial's enrollment parameters stipulate that participants must be at least 18 years of age and not exceed 45."

Answered by AI

How many participants has the research team recruited for this study?

"Affirmative. Clinicaltrials.gov data suggests that this experiment is actively seeking participants, with the initial listing being posted on September 14th 2022 and its most recent update occurring October 7th 2022. The trial will be enrolling 12 patients at a single site."

Answered by AI

Is there a substantial risk associated with the usage of LYBALVI?

"With limited data available on LYBALVI's both efficacy and safety, our team at Power gave this drug a score of 1."

Answered by AI

Who else is applying?

What state do they live in?
Utah
What site did they apply to?
Alkermes Investigator Site
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan
2022. "Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05547100.
~5 spots leftby Apr 2025
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