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Trial · NCT03443063

Results by group110

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Maximum Observed Plasma Concentration (Cmax) of LemborexantLemborexant: Severe Renal Impairment48.9Geometric Coefficient of Variation 41.0nanogram per milliliter (ng/mL)
Maximum Observed Plasma Concentration (Cmax) of LemborexantLemborexant: Normal Renal Function46.6Geometric Coefficient of Variation 29.2nanogram per milliliter (ng/mL)
Area Under the Plasma Concentration-Time Curve From Time Zero to 72 Hours Post Dose (AUC[0-72h]) of LemborexantLemborexant: Severe Renal Impairment419Geometric Coefficient of Variation 21.9hour*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 LemborexantLemborexant: Normal Renal Function315Geometric Coefficient of Variation 27.4hour*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 LemborexantLemborexant: Severe Renal Impairment660Geometric Coefficient of Variation 29.3h*ng/mL
Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) of LemborexantLemborexant: Normal Renal Function439Geometric Coefficient of Variation 36.9h*ng/mL
Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC[0-inf]) of LemborexantLemborexant: Severe Renal Impairment672Geometric Coefficient of Variation 19.6h*ng/mL
Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC[0-inf]) of LemborexantLemborexant: Normal Renal Function449Geometric Coefficient of Variation 38.3h*ng/mL
Maximum Observed Plasma Concentration (Cmax) of Metabolites of Lemborexant (M4, M9, and M10)Lemborexant: Severe Renal ImpairmentMetabolite M46.37Geometric Coefficient of Variation 44.8ng/mL
Maximum Observed Plasma Concentration (Cmax) of Metabolites of Lemborexant (M4, M9, and M10)Lemborexant: Normal Renal FunctionMetabolite M47.96Geometric Coefficient of Variation 39.5ng/mL
Maximum Observed Plasma Concentration (Cmax) of Metabolites of Lemborexant (M4, M9, and M10)Lemborexant: Severe Renal ImpairmentMetabolite M93.77Geometric Coefficient of Variation 44.1ng/mL
Maximum Observed Plasma Concentration (Cmax) of Metabolites of Lemborexant (M4, M9, and M10)Lemborexant: Normal Renal FunctionMetabolite M94.74Geometric Coefficient of Variation 45.9ng/mL
Maximum Observed Plasma Concentration (Cmax) of Metabolites of Lemborexant (M4, M9, and M10)Lemborexant: Severe Renal ImpairmentMetabolite M102.78Geometric Coefficient of Variation 50.5ng/mL
Maximum Observed Plasma Concentration (Cmax) of Metabolites of Lemborexant (M4, M9, and M10)Lemborexant: Normal Renal FunctionMetabolite M103.83Geometric Coefficient of Variation 48.0ng/mL
Time to Reach Maximum Plasma Concentration (Tmax) of Lemborexant and Its Metabolites (M4, M9, and M10)Lemborexant: Severe Renal ImpairmentLemborexant1.00Full Range 0.50 to 3.00hour (h)
Time to Reach Maximum Plasma Concentration (Tmax) of Lemborexant and Its Metabolites (M4, M9, and M10)Lemborexant: Normal Renal FunctionLemborexant1.00Full Range 1.00 to 1.50hour (h)
Time to Reach Maximum Plasma Concentration (Tmax) of Lemborexant and Its Metabolites (M4, M9, and M10)Lemborexant: Severe Renal ImpairmentMetabolite M43.50Full Range 1.00 to 4.00hour (h)
Time to Reach Maximum Plasma Concentration (Tmax) of Lemborexant and Its Metabolites (M4, M9, and M10)Lemborexant: Normal Renal FunctionMetabolite M42.00Full Range 1.00 to 4.00hour (h)
Time to Reach Maximum Plasma Concentration (Tmax) of Lemborexant and Its Metabolites (M4, M9, and M10)Lemborexant: Severe Renal ImpairmentMetabolite M91.00Full Range 1.00 to 4.00hour (h)
Time to Reach Maximum Plasma Concentration (Tmax) of Lemborexant and Its Metabolites (M4, M9, and M10)Lemborexant: Normal Renal FunctionMetabolite M91.25Full Range 1.00 to 2.00hour (h)

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.

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