Healthy VolunteersPhase 1NCT04890561
A Study to Evaluate Lemborexant in Milk of Healthy Lactating Women
A Phase 1 study testing Lemborexant in people with Healthy Volunteers, run by Eisai Inc. at 1 site in United States.
Trial summary
The primary purpose of the study is to estimate the cumulative amount of lemborexant excreted in breast milk following a single dose administration of lemborexant 10 milligram (mg) to healthy lactating women and to estimate the relative infant dose (RID) expressed as a percent of the daily maternal dose. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Lemborexant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2021to 12 Aug 2021
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Is a healthy lactating female at least 18 years of age and willing to sign an informed consent prior to any study-related activities.
- The participant must have had a normal term pregnancy and has been actively breastfeeding or pumping for at least 5 weeks postpartum; lactation must be well-established and the mother not experiencing problems with feeding her infant breast milk. Participants planning on weaning their infants independent of study participation, who meet aforementioned requirements, will be considered for enrolment in the study.
- Is willing not to breastfeed for 11 days after the study drug administration.
- Breastfeeds an infant who is already able to feed from a bottle.
- Agrees to collect all breast milk from predose to end of the study using an electric pump provided by the sponsor.
- Is considered reliable and capable of adhering to the protocol and visit schedule according to the judgment of the investigator.
Who cannot join
- Has a positive pregnancy test at Screening or Baseline.
- Evidence of disease that may influence the outcome of the study within 4 weeks before dosing; example, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or participants who have a congenital abnormality in metabolism.
- Any history of gastrointestinal surgery that may affect pharmacokinetic (PK) profiles, example, hepatectomy, nephrectomy, digestive organ resection (but not cholecystectomy) at Screening or Baseline.
- Any clinically abnormal symptom or organ impairment found by medical history at Screening, and physical examinations, vital signs, ECG finding, or laboratory test results that require medical treatment at Screening or Baseline.
- A prolonged QT interval by Fridericia (QTcF) (QTcF greater than [>] 450 milliseconds [ms]) as demonstrated by a repeated ECG at Screening.
- Any suicidal behavior (per the Suicidal Behavior section of the Columbia-Suicide Severity Rating Scale) within 10 years of Screening.
Show all 20Show fewer
- Evidence of clinically significant disease (example, cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments.
- Exposure within the last 14 days to an individual with confirmed or probable coronavirus disease (COVID-19) or symptoms within the last 14 days that are on the most recent centers for disease control and prevention (CDC) list of COVID symptoms or any other reason to consider the participant at potential risk for an acute COVID-19 infection.
- Has mastitis or other condition that would prevent the collection of milk from one or both breasts.
- Is a smoker (>5 cigarettes, or nicotine equivalent, per day).
- Has a positive result for urine drug screening.
- Has undergone surgery (other than caesarean section) or donated blood within 8 weeks prior to the start of the study.
- Used any prescription or over-the-counter medications, which may impact plasma concentration of lemborexant, within 1 week or 5 half-lives, whichever is longer, before Screening.
- Hypersensitivity to the study drug or any of the excipients.
- History of or has concomitant medical condition(s) that in the opinion of the investigator(s) would compromise the participant's ability to safely complete the study.
- History of drug or alcohol dependency or abuse within approximately the last 2 years.
- Currently enrolled in another clinical study or used any investigational drug or device within 28 days or 5*the half-life, whichever is longer preceding informed consent.
- Known to be human immunodeficiency virus (HIV) positive at Screening.
- Active viral hepatitis (B or C) as demonstrated by positive serology at Screening.
- Has a current or prior diagnosis of narcolepsy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single Dose Study to Evaluate Lemborexant in Milk of Healthy Lactating Women
The primary purpose of the study is to estimate the cumulative amount of lemborexant excreted in breast milk following a single dose administration of lemborexant 10 milligram (mg) to healthy lactating women and to estimate the relative infant dose (RID) expressed as a percent of the daily maternal dose.
- Conditions
- Healthy Volunteers
- Being tested
- Lemborexant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LemborexantDrug
Also called E2006, Dayvigo
Lemborexant oral tablets.
| Study group | Role | What they receive |
|---|---|---|
| Lemborexant 10 mg | Experimental | Participants will receive a single dose of lemborexant 10 mg tablet, orally on Day 1. Receives: Drug: Lemborexant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ae: Cumulative Total (Unchanged) Amount of Lemborexant Excreted in Breast Milk Over the Entire Collection
Measured: 0-240 hours post-dose
Fraction (Percentage) of Dose Excreted in Breast Milk
Fraction of dose excreted will be calculated as: Ae/Administered dose.
Measured: 0-240 hours post-dose
RID: Relative Infant Dose
Relative infant dose is defined as the infant drug exposure via breast milk which is the body weight-adjusted percentage of maternal dose. Relative infant dose will be calculated by the formula: Daily infant dose milligram per kilogram (mg/kg)/maternal dose (mg/kg)*100, where estimated daily infant dose is as per the Food and Drug Administration (FDA) guidance (2019). Daily infant dose (mg/kg) = Ae/weight of infant.
Measured: 0-240 hours post-dose
Secondary outcomes (6)
Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs)
Measured: Up to 215 days
Number of Participants Reporting one or More TEAEs Based on Severity
All TEAEs will be graded on a 3-point scale (mild, moderate, and severe). The definitions are as follows: Mild (Discomfort noticed, but no disruption of normal daily activity); Moderate (Discomfort sufficient to reduce or affect normal daily activity); Severe (Incapacitating, with inability to work or to perform normal daily activity).
Measured: Up to 215 days
Number of Participants Reporting one or More TEAEs Based on Dose-relationship of Adverse Events (AEs)
Measured: Up to 215 days
Number of Participants With Clinically Significant Change in 12-lead Electrocardiogram (ECG) Findings
Measured: Up to 215 days
Number of Participants With Clinically Significant Change From Baseline in Vital Sign Values
Measured: Baseline up to 215 days
Number of Participants With Markedly Abnormal Change From Baseline in Laboratory Parameters
Measured: Baseline up to 215 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start17 May 2021
- Primary completion12 Aug 2021
- Study completion12 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890561
- Sponsor's protocol ID
- E2006-A001-010
- Status last verified
- May 2021
- First submitted
- 13 May 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Publications
Rawal S, Brimhall D, Aluri J, Cheng JY, Hall N, Moline M. Lemborexant levels in breast milk after single doses in healthy, lactating women. Br J Clin Pharmacol. 2024 Jan;90(1):158-163. doi: 10.1111/bcp.15880. Epub 2023 Aug 23.
PubMed 37565541
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single Dose Study to Evaluate Lemborexant in Milk of Healthy Lactating Women
- ClinicalTrials.gov ID
- NCT04890561
- Acronym / sponsor ID
- E2006-A001-010
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- 17 May 2021 (actual)
- Primary completion
- 12 Aug 2021 (actual)
- Study completion
- 12 Aug 2021 (actual)
- First posted
- 18 May 2021 (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.
The primary purpose of the study is to estimate the cumulative amount of lemborexant excreted in breast milk following a single dose administration of lemborexant 10 milligram (mg) to healthy lactating women and to estimate the relative infant dose (RID) expressed as a percent of the daily maternal dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lemborexant 10 mg | Experimental | Drug: LemborexantParticipants will receive a single dose of lemborexant 10 mg tablet, orally on Day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Is a healthy lactating female at least 18 years of age and willing to sign an informed consent prior to any study-related activities.
- The participant must have had a normal term pregnancy and has been actively breastfeeding or pumping for at least 5 weeks postpartum; lactation must be well-established and the mother not experiencing problems with feeding her infant breast milk. Participants planning on weaning their infants independent of study participation, who meet aforementioned requirements, will be considered for enrolment in the study.
- Is willing not to breastfeed for 11 days after the study drug administration.
- Breastfeeds an infant who is already able to feed from a bottle.
- Agrees to collect all breast milk from predose to end of the study using an electric pump provided by the sponsor.
Key exclusion criteria (20 listed)
- Has a positive pregnancy test at Screening or Baseline.
- Evidence of disease that may influence the outcome of the study within 4 weeks before dosing; example, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or participants who have a congenital abnormality in metabolism.
- Any history of gastrointestinal surgery that may affect pharmacokinetic (PK) profiles, example, hepatectomy, nephrectomy, digestive organ resection (but not cholecystectomy) at Screening or Baseline.
- Any clinically abnormal symptom or organ impairment found by medical history at Screening, and physical examinations, vital signs, ECG finding, or laboratory test results that require medical treatment at Screening or Baseline.
- A prolonged QT interval by Fridericia (QTcF) (QTcF greater than [>] 450 milliseconds [ms]) as demonstrated by a repeated ECG at Screening.
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 |
|---|---|---|
| LemborexantAlso: E2006, DayvigoLemborexant oral tablets. | Drug | Lemborexant 10 mg |
Primary outcome
Ae: Cumulative Total (Unchanged) Amount of Lemborexant Excreted in Breast Milk Over the Entire Collection
Time frame: 0-240 hours post-dose
Fraction (Percentage) of Dose Excreted in Breast Milk
Time frame: 0-240 hours post-dose
Fraction of dose excreted will be calculated as: Ae/Administered dose.
RID: Relative Infant Dose
Time frame: 0-240 hours post-dose
Relative infant dose is defined as the infant drug exposure via breast milk which is the body weight-adjusted percentage of maternal dose. Relative infant dose will be calculated by the formula: Daily infant dose milligram per kilogram (mg/kg)/maternal dose (mg/kg)*100, where estimated daily infant dose is as per the Food and Drug Administration (FDA) guidance (2019). Daily infant dose (mg/kg) = Ae/weight of infant.
6 secondary outcomes
Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 215 days
Number of Participants Reporting one or More TEAEs Based on Severity
Time frame: Up to 215 days
Number of Participants Reporting one or More TEAEs Based on Dose-relationship of Adverse Events (AEs)
Time frame: Up to 215 days
Number of Participants With Clinically Significant Change in 12-lead Electrocardiogram (ECG) Findings
Time frame: Up to 215 days
Number of Participants With Clinically Significant Change From Baseline in Vital Sign Values
Time frame: Baseline up to 215 days
Number of Participants With Markedly Abnormal Change From Baseline in Laboratory Parameters
Time frame: Baseline up to 215 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 5 Sep 2021.
- Derived from this study: PubMed 37565541Rawal S, Brimhall D, Aluri J, Cheng JY, Hall N, Moline M. Lemborexant levels in breast milk after single doses in healthy, lactating women. Br J Clin Pharmacol. 2024 Jan;90(1):158-163. doi: 10.1111/bcp.15880. Epub 2023 Aug 23.
- Individual participant dataSharing planned: Yes. Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lemborexant in people with Healthy Volunteers, run by Eisai 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 20 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 5 Sep 2021. 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?
Ae: Cumulative Total (Unchanged) Amount of Lemborexant Excreted in Breast Milk Over the Entire Collection (time frame: 0-240 hours post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04890561, which also lists 1 linked publication.
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 5 Sep 2021.