Trial · NCT03443063
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| 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 | |
| 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 | 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). |
| 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 | 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. |
| 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 | 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. |
| 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 | Estimated by linear regression through at least three data points (not including tmax) in the terminal phase of the log concentration-time profile. |
| Secondary | Apparent Body Clearance (CL/F) of Lemborexant | Day 1: predose, 0.5 up to 240 hours postdose | 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. |
| 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 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 /(\[ λz\]\*\[AUC0-inf\]). |
| 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 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. |
| 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 | 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. |
| 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 | Unbound fraction of drug in plasma was calculated as 100% - mean percent of Lemborexant bound to plasma protein for each participant. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Up to Day 11 |
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.
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GET https://conductscience.org/api/trials/v1/NCT03443063/registered