Trial · NCT03443063
Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Normal Renal Function or With Severe Renal Impairment
NCT03443063, Phase 1, Completed, Eisai Inc.; results first posted 2020-01-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Normal Renal Function or With Severe Renal Impairment. Trials, record NCT03443063. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03443063
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Normal Renal Function or With Severe Renal Impairment
- NCT number
- NCT03443063
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 16 participants, actual
- Lead sponsor
- Eisai Inc.
- Conditions
- Renal Impairment
- Interventions
- Lemborexant
- First posted
- 2018-02-22
- Last updated
- 2020-03-12
- Results first posted
- 2020-01-18
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Observed Plasma Concentration (Cmax) of Lemborexant | Day 1: predose, 0.5 up to 240 hours postdose | |
| Primary | Area Under the Plasma Concentration-Time Curve From Time Zero to 72 Hours Post Dose (AUC[0-72h]) of Lemborexant | Day 1: predose, 0.5 up to 72 hours postdose | |
| Primary | Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) of Lemborexant | Day 1: predose, 0.5 up to 240 hours postdose | |
| Primary | Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC[0-inf]) of Lemborexant | Day 1: predose, 0.5 up to 240 hours postdose | |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of Metabolites of Lemborexant (M4, M9, and M10) | Day 1: predose, 0.5 up to 240 hours postdose | |
| Secondary | Time to Reach Maximum Plasma Concentration (Tmax) of Lemborexant and Its Metabolites (M4, M9, and M10) | Day 1: predose, 0.5 up to 240 hours postdose | |
| Secondary | 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) | Day 1: predose, 0.5 up to 8 hours postdose | |
| Secondary | 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) | Day 1: predose, 0.5 up to 72 hours postdose | |
| Secondary | 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) | Day 1: predose, 0.5 up to 240 hours postdose | |
| Secondary | Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC[0-inf]) of Metabolites of Lemborexant (M4, M9, and M10) | Day 1: predose, 0.5 up to 240 hours postdose |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Observed Plasma Concentration (Cmax) of Lemborexant | Day 1: predose, 0.5 up to 240 hours postdose | 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. | nanogram per milliliter (ng/mL) | GEOMETRIC_MEAN |
| PRIMARY | Area Under the Plasma Concentration-Time Curve From Time Zero to 72 Hours Post Dose (AUC[0-72h]) of Lemborexant | Day 1: predose, 0.5 up to 72 hours postdose | 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. | hour*nanogram per milliliter (h*ng/mL) | GEOMETRIC_MEAN |
| PRIMARY | Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) of Lemborexant | Day 1: predose, 0.5 up to 240 hours postdose | 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. | h*ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC[0-inf]) of Lemborexant | Day 1: predose, 0.5 up to 240 hours postdose | 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. | h*ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) of Metabolites of Lemborexant (M4, M9, and M10) | Day 1: predose, 0.5 up to 240 hours postdose | 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. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Time to Reach Maximum Plasma Concentration (Tmax) of Lemborexant and Its Metabolites (M4, M9, and M10) | Day 1: predose, 0.5 up to 240 hours postdose | 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. | hour (h) | MEDIAN |
| SECONDARY | 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) | Day 1: predose, 0.5 up to 8 hours postdose | 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. | h*ng/mL | GEOMETRIC_MEAN |
| SECONDARY | 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) | Day 1: predose, 0.5 up to 72 hours postdose | 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. | h*ng/mL | GEOMETRIC_MEAN |
| SECONDARY | 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) | Day 1: predose, 0.5 up to 240 hours postdose | 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. | h*ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC[0-inf]) of Metabolites of Lemborexant (M4, M9, and M10) | Day 1: predose, 0.5 up to 240 hours postdose | 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 number analyzed signifies the participants who were evaluable for analysis for specific metabolite of lemborexant for this outcome measure. | h*ng/mL | GEOMETRIC_MEAN |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group110
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Lemborexant | Lemborexant: Severe Renal Impairment | 48.9 | Geometric Coefficient of Variation 41.0 | nanogram per milliliter (ng/mL) | |
| Maximum Observed Plasma Concentration (Cmax) of Lemborexant | Lemborexant: Normal Renal Function | 46.6 | Geometric Coefficient of Variation 29.2 | nanogram per milliliter (ng/mL) | |
| Area Under the Plasma Concentration-Time Curve From Time Zero to 72 Hours Post Dose (AUC[0-72h]) of Lemborexant | Lemborexant: Severe Renal Impairment | 419 | Geometric Coefficient of Variation 21.9 | hour*nanogram per milliliter (h*ng/mL) | |
| Area Under the Plasma Concentration-Time Curve From Time Zero to 72 Hours Post Dose (AUC[0-72h]) of Lemborexant | Lemborexant: Normal Renal Function | 315 | Geometric Coefficient of Variation 27.4 | hour*nanogram per milliliter (h*ng/mL) | |
| Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) of Lemborexant | Lemborexant: Severe Renal Impairment | 660 | Geometric Coefficient of Variation 29.3 | h*ng/mL | |
| Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) of Lemborexant | Lemborexant: Normal Renal Function | 439 | Geometric Coefficient of Variation 36.9 | h*ng/mL | |
| Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC[0-inf]) of Lemborexant | Lemborexant: Severe Renal Impairment | 672 | Geometric Coefficient of Variation 19.6 | h*ng/mL | |
| Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC[0-inf]) of Lemborexant | Lemborexant: Normal Renal Function | 449 | Geometric Coefficient of Variation 38.3 | h*ng/mL | |
| Maximum Observed Plasma Concentration (Cmax) of Metabolites of Lemborexant (M4, M9, and M10) | Lemborexant: Severe Renal Impairment | Metabolite M4 | 6.37 | Geometric Coefficient of Variation 44.8 | ng/mL |
| Maximum Observed Plasma Concentration (Cmax) of Metabolites of Lemborexant (M4, M9, and M10) | Lemborexant: Normal Renal Function | Metabolite M4 | 7.96 | Geometric Coefficient of Variation 39.5 | ng/mL |
1 to 10 of 110Source ClinicalTrials.gov
See all 110 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lemborexant: Severe Renal Impairment | 8 | |
| Overall Study | STARTED | Lemborexant: Normal Renal Function | 8 | |
| Overall Study | COMPLETED | Lemborexant: Severe Renal Impairment | 8 | |
| Overall Study | COMPLETED | Lemborexant: Normal Renal Function | 8 | |
| Overall Study | NOT COMPLETED | Lemborexant: Severe Renal Impairment | 0 | |
| Overall Study | NOT COMPLETED | Lemborexant: Normal Renal Function | 0 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Chills | General disorders | Lemborexant: Severe Renal Impairment | 1 | 8 | |
| other | Chills | General disorders | Lemborexant: Normal Renal Function | 0 | 8 | |
| other | Somnolence | Nervous system disorders | Lemborexant: Severe Renal Impairment | 5 | 8 | |
| other | Somnolence | Nervous system disorders | Lemborexant: Normal Renal Function | 7 | 8 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lemborexant: Severe Renal Impairment | 0 | 8 |
| Total, all-cause mortality | Lemborexant: Normal Renal Function | 0 | 8 |
| Total, other adverse events | Lemborexant: Severe Renal Impairment | 5 | 8 |
| Total, other adverse events | Lemborexant: Normal Renal Function | 7 | 8 |
| Total, serious adverse events | Lemborexant: Severe Renal Impairment | 0 | 8 |
| Total, serious adverse events | Lemborexant: Normal Renal Function | 0 | 8 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Lemborexant: Severe Renal Impairment vs Lemborexant: Normal Renal Function: Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Parameter Values | Trial comparisons |
| Lemborexant: Severe Renal Impairment vs Lemborexant: Normal Renal Function: Number of Participants With Clinically Significant Abnormal Vital Sign Values | Trial comparisons |
| Lemborexant: Severe Renal Impairment vs Lemborexant: Normal Renal Function: Number of Participants With Clinically Significant Laboratory Abnormalities | Trial comparisons |
| Lemborexant: Severe Renal Impairment vs Lemborexant: Normal Renal Function: deaths from any cause | Trial comparisons |
| Lemborexant: Severe Renal Impairment vs Lemborexant: Normal Renal Function: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03443063
GET https://conductscience.org/api/trials/v1/NCT03443063/registered?page=2