Focus of Study is on Healthy Lactating WomenPhase 1NCT05547100
Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan
A Phase 1 study testing LYBALVI in people with Focus of Study is on Healthy Lactating Women, run by Alkermes, Inc. at 1 site in United States.
Trial summary
This clinical lactation study is to provide information regarding the PK and amount of OLZ/SAM in breast milk and estimated infant exposure. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Focus of Study is on Healthy Lactating Women
- What is being tested?
- LYBALVI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2022to 19 Nov 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 post-dose
- Subject is exclusively breastfeeding and/or pumping milk, or if not exclusively breastfeeding/pumping, has an adequate milk supply as judged by the Investigator
- Subject's infant is able to bottle-feed
- Subject agrees to use contraception during the study
Who cannot join
- Subject has a history of lumpectomy, mastectomy, breast implants, breast augmentation, or breast reduction surgery
- Breastfeeding is not well-established or milk supply is low as judged by the Investigator
- Subject has mastitis or other condition that may prevent the collection of milk from one or both breasts
- Subject is pregnant or plans to become pregnant during the study
- Subject has had a clinically significant illness within 30 days or has had a serious infection (eg, pneumonia or septicemia) within the 3 months
- Subject has had any vaccination within 2 weeks prior to Screening or plans to have any vaccination during the study
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- Subject has a history of known or suspected intolerance, allergy, or hypersensitivity to olanzapine or opioid antagonists, , or any component of the study drug (eg naltrexone, naloxone)
- Subject has a history of cardiovascular disease, cerebrovascular disease, a seizure disorder, personal or family history of neuroleptic malignant syndrome, or known risk of narrow-angle glaucoma or orthostatic hypotension
- Subject has a current or anticipated need for prescribed opioid medication during the study period
- Subject has a positive urine drug screen for amphetamine, barbiturates, cannabinoids, cocaine, or opioids or positive cotinine test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan in Healthy Lactating Women
This clinical lactation study is to provide information regarding the PK and amount of OLZ/SAM in breast milk and estimated infant exposure.
- Being tested
- LYBALVI
- Keywords
- Samidorphan, Healthy Lactating Women, LYBALVI, ALKS 3831, Breast milk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LYBALVIDrug
Also called Olanzapine/samidorphan (OLZ/SAM), ALKS 3831
5 mg Olanzapine/10 mg Samidorphan dose approved for use in treatment for schizophrenia and bipolar I disorder
| Study group | Role | What they receive |
|---|---|---|
| 5mg OLZAPINE /10mg SAMIDORPHAN | Experimental | Open label, single dose 5mg OLZ/10 mg SAM Receives: Drug: LYBALVI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve from time zero to 48 hours post-dose (AUC0 48)
Measured: Up to 15 days
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Measured: Up to 15 days
Area under the concentration-time curve from time zero to infinity (AUC∞)
Measured: Up to 15 days
\Maximum observed concentration (Cmax)
Measured: Up to 15 days
Time to reach Cmax (tmax)
Measured: Up to 15 days
Terminal half-life (t½)
Measured: Up to 15 days
Secondary outcomes (5)
Total amount of drug excreted in milk (milligrams)
Measured: Up to 15 days
Relative drug excreted in milk to dose percentage
Measured: Up to 15 days
Estimated infant dose (mg/kg)
Measured: Up to 15 days
Estimated relative infant dose to the weight-adjusted maternal dose (%)
Measured: Up to 15 days
Incidence of adverse events
Measured: Up to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start14 Sep 2022
- Primary completion19 Nov 2022
- Study completion19 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus of Study is on Healthy Lactating WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alkermes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sergey Yagoda, MD, PhD, Study director, Alkermes, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547100
- Sponsor's protocol ID
- ALKS 3831-112
- Status last verified
- Feb 2023
- First submitted
- 16 Sep 2022
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan in Healthy Lactating Women
- ClinicalTrials.gov ID
- NCT05547100
- Acronym / sponsor ID
- ALKS 3831-112
- Keywords
- Samidorphan, Healthy Lactating Women, LYBALVI, ALKS 3831, Breast milk
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- 19 Nov 2022 (actual)
- Study completion
- 19 Nov 2022 (actual)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical lactation study is to provide information regarding the PK and amount of OLZ/SAM in breast milk and estimated infant exposure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 5mg OLZAPINE /10mg SAMIDORPHAN | Experimental | Drug: LYBALVIOpen label, single dose 5mg OLZ/10 mg SAM |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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 post-dose
- Subject is exclusively breastfeeding and/or pumping milk, or if not exclusively breastfeeding/pumping, has an adequate milk supply as judged by the Investigator
- Subject's infant is able to bottle-feed
Key exclusion criteria (10 listed)
- Subject has a history of lumpectomy, mastectomy, breast implants, breast augmentation, or breast reduction surgery
- Breastfeeding is not well-established or milk supply is low as judged by the Investigator
- Subject has mastitis or other condition that may prevent the collection of milk from one or both breasts
- Subject is pregnant or plans to become pregnant during the study
- Subject has had a clinically significant illness within 30 days or has had a serious infection (eg, pneumonia or septicemia) within the 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LYBALVIAlso: Olanzapine/samidorphan (OLZ/SAM), ALKS 38315 mg Olanzapine/10 mg Samidorphan dose approved for use in treatment for schizophrenia and bipolar I disorder | Drug | 5mg OLZAPINE /10mg SAMIDORPHAN |
Primary outcome
Area under the concentration-time curve from time zero to 48 hours post-dose (AUC0 48)
Time frame: Up to 15 days
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Time frame: Up to 15 days
Area under the concentration-time curve from time zero to infinity (AUC∞)
Time frame: Up to 15 days
\Maximum observed concentration (Cmax)
Time frame: Up to 15 days
Time to reach Cmax (tmax)
Time frame: Up to 15 days
Terminal half-life (t½)
Time frame: Up to 15 days
5 secondary outcomes
Total amount of drug excreted in milk (milligrams)
Time frame: Up to 15 days
Relative drug excreted in milk to dose percentage
Time frame: Up to 15 days
Estimated infant dose (mg/kg)
Time frame: Up to 15 days
Estimated relative infant dose to the weight-adjusted maternal dose (%)
Time frame: Up to 15 days
Incidence of adverse events
Time frame: Up to 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergey Yagoda, MD, PhD study director
Alkermes, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LYBALVI in people with Focus of Study is on Healthy Lactating Women, run by Alkermes, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the concentration-time curve from time zero to 48 hours post-dose (AUC0 48) (time frame: Up to 15 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.