Renal ImpairmentPhase 1NCT03443063

Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Normal Renal Function or With Severe Renal Impairment

A Phase 1 study testing Lemborexant in people with Renal Impairment, run by Eisai Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study will be conducted to assess the effect of severe renal impairment on the pharmacokinetics of lemborexant after a single-dose administration. Read more about this study

Who is it for?: Ages 18 to 79 yearsHealthy volunteers can take part
Conditions the study is for: Renal Impairment
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: 16 participants
Where: 2 sitesUnited States
Study dates: 7 Feb 2018to 24 Aug 2018
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 79 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male or female participants, ages 18 to 79 years, inclusive, at the time of informed consent.
Body Mass Index between 18 and 40 kilograms per meters squared (kg/m^2), inclusive, at Screening.
Voluntary agreement to provide written informed consent, and the willingness and ability to comply with all aspects of the protocol.
Nonsmokers or smokers who smoke 20 cigarettes or less per day.
Participants with normal liver function.
Additional Inclusion Criteria for Healthy Participants:

Show all 9Show fewer

Estimated glomerular filtration rate (eGFR) is ≥ 90 mL/min/1.73 m^2, as determined by the Modification of Diet in Renal Disease (MDRD) formula.
Additional Inclusion Criteria for Participants with Renal Impairment:
Diagnosis of severe renal impairment (eGFR is 15 to 29 mL/min/1.73 m^2, as determined by the MDRD formula) that has been stable (without any change in disease status) for 60 days prior to study Screening and is confirmed on Day -1, as determined by the investigator by MDRD formula. If the renal function classification for the participant changed from screening to Day -1, eGFR should be repeated once within 24 to 48 hours. If eGFR variability across these scheduled and repeat time points indicates the participant does not consistently meet the criteria for one renal category group, participant enrollment into a renal category group will be at the discretion of the medical monitor and investigator, in consultation with the Sponsor.

Who cannot join

Females who are breastfeeding or pregnant at Screening or Baseline.
Females of childbearing potential who did not use a highly effective method of contraception within 28 days before study entry, or who did not agree to use an approved method of contraception from 28 days before study entry, throughout the entire study period, and for 28 days after study drug discontinuation.
Intake of food supplements (including herbal preparations), foods or beverages that may affect cytochrome P450 (CYP) 3A4 (CYP3A4) enzyme (e.g., alcohol, grapefruit, grapefruit juice, grapefruit-containing beverages, apple or orange juice, vegetables from the mustard green family [e.g., kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, mustard] and charbroiled meats) within 2 weeks before dosing until study discharge.
Use of an herbal preparation containing Saint John's Wort within 4 weeks before dosing until study discharge.
Known to be positive for human immunodeficiency virus.
Presence of acute and active liver disease, or acute liver injury, as indicated by (1) an abnormal liver function test, or (2) clinical or laboratory signs of acute, active viral hepatitis (including B and C as demonstrated by positive serology at Screening). Participants with stable, chronic, inactive viral hepatitis B or C may be enrolled based on investigator's opinion.

Show all 24Show fewer

Corrected QT interval for heart rate on electrocardiograms (ECGs) by Fridericia's formula (QTcF) >480 milliseconds (msec) at Screening or Day -1. Before excluding a participant with QTcF >480 msec at Screening, ECG should be repeated once to confirm.
A known or suspected history of drug or alcohol abuse disorder within 6 months prior to Screening.
A positive urine drug test or a positive breathalyzer alcohol test at Screening or Day -1.
Participation in another interventional clinical trial within 4 weeks, or 5 times the half-life of the investigational drug (whichever is longer), of lemborexant administration.
Engaged in heavy/strenuous physical exercise within 2 weeks prior to check-in on Day -1 (e.g., marathon runners, weight lifters).
Unwilling to abide by the study requirements, or in the opinion of the investigator, is not likely to complete the study.
History of clinically significant drug or food allergies, or is presently experiencing significant seasonal allergies.
Recent weight change that is considered clinically significant by the Investigator.
Clinically significant findings revealed by physical examination, assessment of vital signs, ECG, or clinical laboratory testing.
Use of any prohibited prescription or over-the-counter medication within 2 weeks or 5 half-lives (whichever is longer) before Screening, or plans to use any such treatment during the study. For participants with renal impairment, chronic stable administration of medications necessary for maintaining the clinical status of the participant may be permitted after consultation with the Medical Monitor.
Additional Exclusion Criteria for Healthy Participants:
Presence of clinically significant illness requiring treatment or that may influence the outcome of the study (e.g., psychiatric disorders, disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system), a history of myocardial infraction, or a congenital abnormality.
Receipt or donation of blood or blood products within 4 to 8 weeks prior to study drug administration.
Additional Exclusion Criteria for Participants With Renal Impairment:
Any history of renal transplant.
Any known significant bleeding diathesis (e.g., history of recent bleeding from esophageal varices), which could preclude multiple venipuncture or deep intramuscular injections.
New significant illness that onset within 2 weeks prior to study drug administration.
Current clinically relevant disease other than the renal impairment (e.g., cardiac, hepatic, gastrointestinal disorder, or a condition which may impact drug absorption), as determined by the investigator. Participants with a history of Type I or Type II diabetes may be eligible, providing that, in the investigator's opinion, the disease has been stable. Participants receiving insulin therapy may be eligible provided they have been on a stable (i.e., dose has not changed) treatment for at least 2 weeks prior to study enrollment and will continue the treatment throughout the study.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Clinical Pharmacology of Miami, LLC
Miami, Florida, 33014
Orlando Clinical Research Center
Orlando, Florida, 32809

Other trials in United States

About this study

Official title: An Open-label, Parallel-Group Study to Evaluate the Pharmacokinetics of Lemborexant and Its Metabolites in Subjects With Normal Renal Function or With Severe Renal Impairment

This study will be conducted to assess the effect of severe renal impairment on the pharmacokinetics of lemborexant after a single-dose administration.

Conditions: Renal Impairment
Being tested: Lemborexant
Keywords: severe renal impairment, lemborexant, normal renal function, healthy participants, metabolites, E2006, pharmacokinetics
Medical subject headings: Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LemborexantDrug
Also called E2006
oral tablet

Study groups in NCT03443063
Study group	Role	What they receive
Group 1: Severe Renal Impairment	Experimental	Participants with severe renal impairment (estimated glomerular filtration rate [eGFR] 15 to 29 milliliters per minute (mL/min/1.73 square meter [m^2]) and not on dialysis) will receive a single dose of 10 milligrams (mg) lemborexant (oral tablet) in the morning after an overnight fast. Receives: Drug: Lemborexant
Group 2: Normal Renal Function	Experimental	Participants with normal renal function (eGFR ≥90 mL/min/1.73 m^2) demographically matched to participants in Group 1 will receive a single dose of 10 mg lemborexant (oral tablet) in the morning after an overnight fast. Receives: Drug: Lemborexant

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Plasma Concentration (Cmax) of Lemborexant
Measured: Day 1: predose, 0.5 up to 240 hours postdose
Area Under the Plasma Concentration-Time Curve From Time Zero to 72 Hours Post Dose (AUC[0-72h]) of Lemborexant
Measured: Day 1: predose, 0.5 up to 72 hours postdose
Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) of Lemborexant
Measured: Day 1: predose, 0.5 up to 240 hours postdose
Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC[0-inf]) of Lemborexant
Measured: Day 1: predose, 0.5 up to 240 hours postdose

Secondary outcomes (19)

Maximum Observed Plasma Concentration (Cmax) of Metabolites of Lemborexant (M4, M9, and M10)
Measured: Day 1: predose, 0.5 up to 240 hours postdose
Time to Reach Maximum Plasma Concentration (Tmax) of Lemborexant and Its Metabolites (M4, M9, and M10)
Measured: Day 1: predose, 0.5 up to 240 hours postdose
Area Under the Plasma Concentration-Time Curve From Time Zero to 8 Hours Post Dose (AUC[0-8h]) of Lemborexant and Its Metabolites (M4, M9, and M10)
Measured: Day 1: predose, 0.5 up to 8 hours postdose
Area Under the Plasma Concentration-Time Curve From Time Zero to 72 Hours Post Dose (AUC[0-72h]) of Metabolites of Lemborexant (M4, M9, and M10)
Measured: Day 1: predose, 0.5 up to 72 hours postdose
Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) of Metabolites of Lemborexant (M4, M9, and M10)
Measured: Day 1: predose, 0.5 up to 240 hours postdose
Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC[0-inf]) of Metabolites of Lemborexant (M4, M9, and M10)
Measured: Day 1: predose, 0.5 up to 240 hours postdose
Area Under the Plasma Concentration-Time Curve Adjusted by Unbound Fraction of Plasma (AUCu) of Lemborexant and Its Metabolites (M4, M9, and M10)
AUCu was defined as the AUC(0-inf) adjusted by unbound fraction in plasma, and calculated by multiplying the value of AUC(0-inf) with Plasma protein unbound fraction (fu).
Measured: Day 1: predose, 0.5 up to 240 hours postdose
Percentage of AUC(0-inf) Based on Extrapolation (AUCex) of Lemborexant and Its Metabolites (M4, M9, and M10)
AUCex was calculated by dividing the difference of (AUC(0-inf) and AUC(0-t)) by value of AUC(0-inf) and then multiplying the value by 100.
Measured: Day 1: predose, 0.5 up to 240 hours postdose
Observed Terminal Elimination Half-life (t1/2) of Lemborexant and Its Metabolites (M4, M9, and M10)
Terminal plasma half-life is the time required for plasma/blood concentration to decrease by 50%. This is not the time required to eliminate half the administered dose.
Measured: Day 1: predose, 0.5 up to 240 hours postdose
Observed Elimination Rate Constant (LambdaZ) of Lemborexant and Its Metabolites (M4, M9, and M10)
Estimated by linear regression through at least three data points (not including tmax) in the terminal phase of the log concentration-time profile.
Measured: Day 1: predose, 0.5 up to 240 hours postdose
Apparent Body Clearance (CL/F) of Lemborexant
CL/F is the clearance for parent Lemborexant only and was calculated as Dose/[AUC0-inf]. Blood samples were analyzed for the amount of Lemborexant in the plasma.
Measured: Day 1: predose, 0.5 up to 240 hours postdose
Apparent Volume of Distribution (Vz/F) Based on the Terminal Phase of Lemborexant
The apparent volume of distribution gives information about the amount of Lemborexant distributed in body tissue rather than the blood/plasma. Vz/F for parent Lemborexant only was calculated as Dose /([ λz]*[AUC0-inf]).
Measured: Day 1: predose, 0.5 up to 240 hours postdose
Metabolite-to-Parent Ratio of AUC(0-inf), Corrected for Molecular Weights (MPR AUC[0-inf]) of Metabolites of Lemborexant (M4, M9, and M10)
The AUC metabolite to parent ratio (MPR) is the ratio of AUC(0-inf) of the individual metabolite to AUC(0-inf) of lemborexant, corrected for molecular weights.
Measured: Day 1: predose, 0.5 up to 240 hours postdose
Plasma Protein Unbound Fraction (Fu) of Lemborexant and Its Metabolites (M4, M9, and M10)
Unbound fraction of drug in plasma was calculated as 100% minus (-) mean percent of Lemborexant and Its Metabolites M4. M9. M10 bound to plasma protein for each participant.
Measured: Day 1: predose, 0.5 up to 240 hours postdose
Apparent Clearance Relative to the Unbound Plasma Concentration (CLu/F) Based on AUCu of Lemborexant
Unbound fraction of drug in plasma was calculated as 100% - mean percent of Lemborexant bound to plasma protein for each participant.
Measured: Day 1: predose, 0.5 up to 240 hours postdose
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured: Up to Day 11
Number of Participants With Clinically Significant Laboratory Abnormalities
Measured: Up to Day 11
Number of Participants With Clinically Significant Abnormal Vital Sign Values
Measured: Up to Day 11
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Parameter Values
Measured: Up to Day 11

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Feb 201824 Aug 2018

First posted22 Feb 2018
Study start7 Feb 2018
Primary completion24 Aug 2018
Study completion24 Aug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Renal ImpairmentStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03443063
Sponsor's protocol ID: E2006-A001-105
Status last verified: Jul 2018
First submitted: 16 Feb 2018
Last updated: 12 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant

All Renal Impairment trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Parallel-Group Study to Evaluate the Pharmacokinetics of Lemborexant and Its Metabolites in Subjects With Normal Renal Function or With Severe Renal Impairment
ClinicalTrials.gov ID: NCT03443063
Acronym / sponsor ID: E2006-A001-105
Conditions: Renal Impairment
Keywords: severe renal impairment, lemborexant, normal renal function, healthy participants, metabolites, E2006, pharmacokinetics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Eisai Inc.Industry (pharma, biotech, devices)
Collaborators: Purdue Pharma LP
Study start: 7 Feb 2018 (actual)
Primary completion: 24 Aug 2018 (actual)
Study completion: 24 Aug 2018 (actual)
First posted: 22 Feb 2018 (actual)
Results: Posted 18 Jan 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will be conducted to assess the effect of severe renal impairment on the pharmacokinetics of lemborexant after a single-dose administration.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group 1: Severe Renal Impairment	Experimental	Drug: LemborexantParticipants with severe renal impairment (estimated glomerular filtration rate [eGFR] 15 to 29 milliliters per minute (mL/min/1.73 square meter [m^2]) and not on dialysis) will receive a single dose of 10 milligrams (mg) lemborexant (oral tablet) in the morning after an overnight fast.
Group 2: Normal Renal Function	Experimental	Drug: LemborexantParticipants with normal renal function (eGFR ≥90 mL/min/1.73 m^2) demographically matched to participants in Group 1 will receive a single dose of 10 mg lemborexant (oral tablet) in the morning after an overnight fast.

Who may qualify

Ages: 18 to 79 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Male or female participants, ages 18 to 79 years, inclusive, at the time of informed consent.
Body Mass Index between 18 and 40 kilograms per meters squared (kg/m^2), inclusive, at Screening.
Voluntary agreement to provide written informed consent, and the willingness and ability to comply with all aspects of the protocol.
Nonsmokers or smokers who smoke 20 cigarettes or less per day.
Participants with normal liver function.

Key exclusion criteria (24 listed)

Females who are breastfeeding or pregnant at Screening or Baseline.
Females of childbearing potential who did not use a highly effective method of contraception within 28 days before study entry, or who did not agree to use an approved method of contraception from 28 days before study entry, throughout the entire study period, and for 28 days after study drug discontinuation.
Intake of food supplements (including herbal preparations), foods or beverages that may affect cytochrome P450 (CYP) 3A4 (CYP3A4) enzyme (e.g., alcohol, grapefruit, grapefruit juice, grapefruit-containing beverages, apple or orange juice, vegetables from the mustard green family [e.g., kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, mustard] and charbroiled meats) within 2 weeks before dosing until study discharge.
Use of an herbal preparation containing Saint John's Wort within 4 weeks before dosing until study discharge.
Known to be positive for human immunodeficiency virus.

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: E2006oral tablet	Drug	Group 1: Severe Renal Impairment, Group 2: Normal Renal Function

Primary outcome

Maximum Observed Plasma Concentration (Cmax) of Lemborexant
Time frame: Day 1: predose, 0.5 up to 240 hours postdose
Area Under the Plasma Concentration-Time Curve From Time Zero to 72 Hours Post Dose (AUC[0-72h]) of Lemborexant
Time frame: Day 1: predose, 0.5 up to 72 hours postdose
Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) of Lemborexant
Time frame: Day 1: predose, 0.5 up to 240 hours postdose
Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC[0-inf]) of Lemborexant
Time frame: Day 1: predose, 0.5 up to 240 hours postdose

19 secondary outcomes

Maximum Observed Plasma Concentration (Cmax) of Metabolites of Lemborexant (M4, M9, and M10)
Time frame: Day 1: predose, 0.5 up to 240 hours postdose
Time to Reach Maximum Plasma Concentration (Tmax) of Lemborexant and Its Metabolites (M4, M9, and M10)
Time frame: Day 1: predose, 0.5 up to 240 hours postdose
Area Under the Plasma Concentration-Time Curve From Time Zero to 8 Hours Post Dose (AUC[0-8h]) of Lemborexant and Its Metabolites (M4, M9, and M10)
Time frame: Day 1: predose, 0.5 up to 8 hours postdose
Area Under the Plasma Concentration-Time Curve From Time Zero to 72 Hours Post Dose (AUC[0-72h]) of Metabolites of Lemborexant (M4, M9, and M10)
Time frame: Day 1: predose, 0.5 up to 72 hours postdose
Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) of Metabolites of Lemborexant (M4, M9, and M10)
Time frame: Day 1: predose, 0.5 up to 240 hours postdose
Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC[0-inf]) of Metabolites of Lemborexant (M4, M9, and M10)
Time frame: Day 1: predose, 0.5 up to 240 hours postdose
Area Under the Plasma Concentration-Time Curve Adjusted by Unbound Fraction of Plasma (AUCu) of Lemborexant and Its Metabolites (M4, M9, and M10)
Time frame: Day 1: predose, 0.5 up to 240 hours postdose
Percentage of AUC(0-inf) Based on Extrapolation (AUCex) of Lemborexant and Its Metabolites (M4, M9, and M10)
Time frame: Day 1: predose, 0.5 up to 240 hours postdose
Observed Terminal Elimination Half-life (t1/2) of Lemborexant and Its Metabolites (M4, M9, and M10)
Time frame: Day 1: predose, 0.5 up to 240 hours postdose
Observed Elimination Rate Constant (LambdaZ) of Lemborexant and Its Metabolites (M4, M9, and M10)
Time frame: Day 1: predose, 0.5 up to 240 hours postdose
Apparent Body Clearance (CL/F) of Lemborexant
Time frame: Day 1: predose, 0.5 up to 240 hours postdose
Apparent Volume of Distribution (Vz/F) Based on the Terminal Phase of Lemborexant
Time frame: Day 1: predose, 0.5 up to 240 hours postdose
Metabolite-to-Parent Ratio of AUC(0-inf), Corrected for Molecular Weights (MPR AUC[0-inf]) of Metabolites of Lemborexant (M4, M9, and M10)
Time frame: Day 1: predose, 0.5 up to 240 hours postdose
Plasma Protein Unbound Fraction (Fu) of Lemborexant and Its Metabolites (M4, M9, and M10)
Time frame: Day 1: predose, 0.5 up to 240 hours postdose
Apparent Clearance Relative to the Unbound Plasma Concentration (CLu/F) Based on AUCu of Lemborexant
Time frame: Day 1: predose, 0.5 up to 240 hours postdose
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Up to Day 11
Number of Participants With Clinically Significant Laboratory Abnormalities
Time frame: Up to Day 11
Number of Participants With Clinically Significant Abnormal Vital Sign Values
Time frame: Up to Day 11
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Parameter Values
Time frame: Up to Day 11

Results and safety

Results posted to the registry on 18 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lemborexant: Severe Renal Impairment	8	8
Lemborexant: Normal Renal Function	8	8

Primary outcome: Maximum Observed Plasma Concentration (Cmax) of Lemborexant

Time frame: Day 1: predose, 0.5 up to 240 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram per milliliter (ng/mL)

Measure	Lemborexant: Severe Renal Impairment n = 8	Lemborexant: Normal Renal Function n = 8
Value	48.9 (41.0)	46.6 (29.2)

Lemborexant: Severe Renal Impairment vs Lemborexant: Normal Renal Function: Percent (%) ratio of geometric means: 104.83 (90% CI 77.41 to 141.97)

Population analysed: The pharmacokinetic (PK) analysis set was the group of participants who were dosed with the test drug and had sufficient PK data to derive at least one PK parameter.

Primary outcome: Area Under the Plasma Concentration-Time Curve From Time Zero to 72 Hours Post Dose (AUC[0-72h]) of Lemborexant

Time frame: Day 1: predose, 0.5 up to 72 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: hour*nanogram per milliliter (h*ng/mL)

Measure	Lemborexant: Severe Renal Impairment n = 8	Lemborexant: Normal Renal Function n = 8
Value	419 (21.9)	315 (27.4)

Lemborexant: Severe Renal Impairment vs Lemborexant: Normal Renal Function: Percent (%) ratio of geometric means: 133.03 (90% CI 107.30 to 164.93)

Population analysed: The PK analysis set was the group of participants who were dosed with the test drug and had sufficient PK data to derive at least one PK parameter.

Primary outcome: Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) of Lemborexant

Time frame: Day 1: predose, 0.5 up to 240 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: h*ng/mL

Measure	Lemborexant: Severe Renal Impairment n = 8	Lemborexant: Normal Renal Function n = 8
Value	660 (29.3)	439 (36.9)

Lemborexant: Severe Renal Impairment vs Lemborexant: Normal Renal Function: Percent (%) ratio of geometric means: 150.53 (90% CI 113.16 to 200.26)

Population analysed: The PK analysis set was the group of participants who were dosed with the test drug and had sufficient PK data to derive at least one PK parameter.

Primary outcome: Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC[0-inf]) of Lemborexant

Time frame: Day 1: predose, 0.5 up to 240 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: h*ng/mL

Measure	Lemborexant: Severe Renal Impairment n = 7	Lemborexant: Normal Renal Function n = 7
Value	672 (19.6)	449 (38.3)

Lemborexant: Severe Renal Impairment vs Lemborexant: Normal Renal Function: Percent (%) ratio of geometric means: 149.84 (90% CI 113.06 to 198.58)

Population analysed: The PK analysis set was the group of participants who were dosed with the test drug and had sufficient PK data to derive at least one PK parameter. Here "overall number of participants analyzed" signifies the participants who were evaluable for analysis for this outcome measure.

19 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Day 11. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lemborexant: Severe Renal Impairment	0 of 8 (0%)	5 of 8 (62.5%)	0 of 8
Lemborexant: Normal Renal Function	0 of 8 (0%)	7 of 8 (87.5%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Renal Impairment

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant

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.

2 sites 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 Renal Impairment, run by Eisai Inc. at 2 sites 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 9 inclusion and 24 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 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Yes. Results are posted in the registry (first posted 18 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Maximum Observed Plasma Concentration (Cmax) of Lemborexant (time frame: Day 1: predose, 0.5 up to 240 hours postdose). The study lists 4 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 NCT03443063.

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 12 Mar 2020.