Trial · NCT03443063
Outcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| 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 |
| SECONDARY | Area Under the Plasma Concentration-Time Curve Adjusted by Unbound Fraction of Plasma (AUCu) 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. Here number analyzed signifies the participants who were evaluable for analysis for lemborexant and for specific metabolite of lemborexant for this outcome measure. | h*ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Percentage of AUC(0-inf) Based on Extrapolation (AUCex) 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. Here number analyzed signifies the participants who were evaluable for analysis for lemborexant and for specific metabolite of lemborexant for this outcome measure. | percentage of AUCex | GEOMETRIC_MEAN |
| SECONDARY | Observed Terminal Elimination Half-life (t1/2) 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. Here number analyzed signifies the participants who were evaluable for analysis for lemborexant and for specific metabolite of lemborexant for this outcome measure. | hour (h) | MEDIAN |
| SECONDARY | Observed Elimination Rate Constant (LambdaZ) 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. Here number analyzed signifies the participants who were evaluable for analysis for lemborexant and for specific metabolite of lemborexant for this outcome measure. | per hour (1/h) | GEOMETRIC_MEAN |
| SECONDARY | Apparent Body Clearance (CL/F) 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. | liter per hour (L/h) | GEOMETRIC_MEAN |
| SECONDARY | Apparent Volume of Distribution (Vz/F) Based on the Terminal Phase 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. | liter (L) | GEOMETRIC_MEAN |
| SECONDARY | Metabolite-to-Parent Ratio of AUC(0-inf), Corrected for Molecular Weights (MPR 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. | ratio | GEOMETRIC_MEAN |
| SECONDARY | Plasma Protein Unbound Fraction (Fu) 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. Here number analyzed signifies the participants who were evaluable for analysis for lemborexant and for specific metabolite of lemborexant for this outcome measure. | % unbound | GEOMETRIC_MEAN |
| SECONDARY | Apparent Clearance Relative to the Unbound Plasma Concentration (CLu/F) Based on AUCu 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. | liter per hour (L/h) | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Up to Day 11 | The safety analysis set was the group of participants who were dosed with the test drug and had at least one postdose safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03443063/outcomes