Trial · NCT03487913
Outcomes55
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 55
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Observed Plasma Concentration (Cmax) of Lixivaptan in ADPKD Patients | Day 1 (am and pm) and Day 7 (am and pm) | The PKAS consisted of all 31 subjects in the Safety analysis set who received lixivaptan, underwent plasma PK sampling, and were evaluable for this PK outcome. Of these, all 31 subjects contributed to the PK data on Day 1 (am); 30 contributed data to Day 1 (pm); and 29 contributed data to Day 7 (am) and (pm). | ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Maximum Observed Plasma Concentration (Cmax) of WAY-141624 in ADPKD Patients | Day 1 (am and pm) and Day 7 (am and pm) | The PKAS consisted of all 31 subjects in the Safety analysis set who received lixivaptan, underwent plasma PK sampling, and were evaluable for this PK outcome. Missing values and substantial deviations from planned dosing interval durations meant results were excluded from subjects at various time points. | ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Maximum Observed Plasma Concentration (Cmax) of WAY-138451 in ADPKD Patients | Day 1 (am and pm) and Day 7 (am and pm) | The PKAS consisted of all 31 subjects in the Safety analysis set who received lixivaptan, underwent plasma PK sampling, and were evaluable for this PK outcome. Missing values, substantial deviations, and \<3 quantifiable postdose WAY-138451 concentrations meant results were excluded from subjects at various time points. | ng/mL | GEOMETRIC_LEAST_SQUARES_MEAN |
| PRIMARY | Maximum Observed Plasma Concentration (Cmax) of WAY-138758 in ADPKD Patients | Day 1 (am and pm) and Day 7 (am and pm) | The PKAS consisted of all 31 subjects in the Safety analysis set who received lixivaptan, underwent plasma PK sampling, and were evaluable for this PK outcome. Of these, all 31 subjects contributed to the PK data on Day 1 (am); 30 contributed data to Day 1 (pm); and 29 contributed data to Day 7 (am) and (pm). Substantial deviations from planned dosing interval durations meant additional results were excluded from subjects at various time points. | ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Time to Reach Maximum Plasma Concentration (Tmax) of Lixivaptan in ADPKD Patients | Day 1 (am and pm) and Day 7 (am and pm) | The PKAS consisted of all 31 subjects in the Safety analysis set who received lixivaptan, underwent plasma PK sampling, and were evaluable for this PK outcome. Of these, all 31 subjects contributed to the PK data on Day 1 (am); 30 contributed data to Day 1 (pm); and 29 contributed data to Day 7 (am) and (pm). Substantial deviations from planned dosing interval durations meant results were excluded from subjects at various time points. | hours | MEDIAN |
| PRIMARY | Time to Reach Maximum Plasma Concentration (Tmax) of WAY-141624 in ADPKD Patients | Day 1 (am and pm) and Day 7 (am and pm) | The PKAS consisted of all 31 subjects in the Safety analysis set who received lixivaptan, underwent plasma PK sampling, and were evaluable for this PK outcome. Missing values and substantial deviations from planned dosing interval durations meant results were excluded from subjects at various time points. | hours | MEDIAN |
| PRIMARY | Time to Reach Maximum Plasma Concentration (Tmax) of WAY-138451 in ADPKD Patients | Day 1 (am and pm) and Day 7 (am and pm) | The PKAS consisted of all 31 subjects in the Safety analysis set who received lixivaptan, underwent plasma PK sampling, and were evaluable for this PK outcome. Missing values, substantial deviations from planned dosing interval durations, and \<3 quantifiable postdose WAY-138451 concentrations meant results were excluded from subjects at various time points. | hours | MEDIAN |
| PRIMARY | Time to Reach Maximum Plasma Concentration (Tmax) of WAY-138758 in ADPKD Patients | Day 1 (am and pm) and Day 7 (am and pm) | The PKAS consisted of all 31 subjects in the Safety analysis set who received lixivaptan, underwent plasma PK sampling, and were evaluable for this PK outcome. All 31 subjects in the PKAS contributed to the PK data on Day 1 (am); 30 contributed data to Day 1 (pm); and 29 contributed data to Day 7 (am) and (pm). Substantial deviations from planned dosing interval durations and missing values meant results were excluded from subjects at various time points. | hours | MEDIAN |
| PRIMARY | Area Under the Concentration-time Curve From Time 0 Until the Last Quantifiable Concentration (AUC[0-last]) of Lixivaptan in ADPKD Patients | Day 1 (am and pm) and Day 7 (am and pm) | The PKAS consisted of all 31 subjects in the Safety analysis set who received lixivaptan, underwent plasma PK sampling, and were evaluable for this PK outcome. All 31 subjects in the PKAS contributed to the PK data on Day 1 (am); 30 contributed data to Day 1 (pm); 29 contributed data to Day 7 (am), and 27 contributed data to Day 7 (pm). Substantial deviations from planned dosing interval durations and missing values meant results were excluded from subjects at various time points. | ng*hour/mL | GEOMETRIC_MEAN |
| PRIMARY | Area Under the Concentration-time Curve From Time 0 Until the Last Quantifiable Concentration (AUC[0-last]) of WAY-141624 in ADPKD Patients | Day 1 (am and pm) and Day 7 (am and pm) | The PKAS consisted of all 31 subjects in the Safety analysis set who received lixivaptan, underwent plasma PK sampling, and were evaluable for this PK outcome. Missing values and substantial deviations from planned dosing interval durations meant results were excluded from subjects at various time points. | ng*hour/mL | GEOMETRIC_MEAN |
| PRIMARY | Area Under the Concentration-time Curve From Time 0 Until the Last Quantifiable Concentration (AUC[0-last]) of WAY-138451 in ADPKD Patients | Day 1 (am and pm) and Day 7 (am and pm) | The PKAS consisted of all 31 subjects in the Safety analysis set who received lixivaptan, underwent plasma PK sampling, and were evaluable for this PK outcome. Missing values, substantial deviations from planned dosing interval durations, and \<3 quantifiable postdose WAY-138451 concentrations meant results were excluded from subjects at various time points. | ng*hour/mL | GEOMETRIC_MEAN |
| PRIMARY | Area Under the Concentration-time Curve From Time 0 Until the Last Quantifiable Concentration (AUC[0-last]) of WAY-138758 in ADPKD Patients | Day 1 (am and pm) and Day 7 (am and pm) | The PKAS consisted of all 31 subjects in the Safety analysis set who received lixivaptan, underwent plasma PK sampling, and were evaluable for this PK outcome. Missing values and substantial deviations from planned dosing interval durations meant results were excluded from subjects at various time points. | ng*hour/mL | GEOMETRIC_MEAN |
| PRIMARY | Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf]) of Lixivaptan in ADPKD Patients | Day 1 (am) | Upon final PK data analysis, it was evident based upon Day 7 PM profiles (sampled out to 96 hours) that lixivaptan did not appear to have concentration-time data in the terminal phase for Day 1 (AM) or Day 7 AM due to the limited time frame of the dosing intervals of 10 hours. Therefore, the terminal slope-related PK parameter of AUC(0-inf), planned in the protocol/SAP for Day 1 AM, was unable to be calculated due to insufficient sampling duration prior to the PM dose. | ||
| PRIMARY | Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf]) of WAY-141624 in ADPKD Patients | Day 1 (am) | Upon final PK data analysis, it was evident based upon Day 7 PM profiles (sampled out to 96 hours) that WAY-141624 did not appear to have concentration-time data in the terminal phase for Day 1 (AM) or Day 7 AM due to the limited time frame of the dosing intervals of 10 hours. Therefore, the terminal slope-related PK parameter of AUC(0-inf), planned in the protocol/SAP for Day 1 AM, was unable to be calculated due to insufficient sampling duration prior to the PM dose. | ||
| PRIMARY | Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf]) of WAY-138451 in ADPKD Patients | Day 1 (am) | Upon final PK data analysis, it was evident based upon Day 7 PM profiles (sampled out to 96 hours) that WAY-138451 did not appear to have concentration-time data in the terminal phase for Day 1 (AM) or Day 7 AM due to the limited time frame of the dosing intervals of 10 hours. Therefore, the terminal slope-related PK parameter of AUC(0-inf), planned in the protocol/SAP for Day 1 AM, was unable to be calculated due to insufficient sampling duration prior to the PM dose. | ||
| PRIMARY | Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf]) of WAY-138758 in ADPKD Patients | Day 1 (am) | Upon final PK data analysis, it was evident based upon Day 7 PM profiles (sampled out to 96 hours) that WAY-138758 did not appear to have concentration-time data in the terminal phase for Day 1 (AM) or Day 7 AM due to the limited time frame of the dosing intervals of 10 hours. Therefore, the terminal slope-related PK parameter of AUC(0-inf), planned in the protocol/SAP for Day 1 AM, was unable to be calculated due to insufficient sampling duration prior to the PM dose. | ||
| PRIMARY | Terminal Elimination Phase Half-life (t1/2) of Lixivaptan in ADPKD Patients | Day 1 (am) and Day 7 (pm) | Upon final PK data analysis, it was evident based upon Day 7 (pm) profiles that lixivaptan did not have concentration-time data in the terminal phase for Day 1 (am) due to the limited time frame of the dosing intervals of 10 hours. Therefore, t1/2, planned for Day 1 (am), was unable to be calculated due to insufficient sampling duration prior to the PM dose. Missing values and substantial deviations meant results were excluded from subjects at various time points. | hours | GEOMETRIC_MEAN |
| PRIMARY | Terminal Elimination Phase Half-life (t1/2) of WAY-141624 in ADPKD Patients | Day 1 (am) and Day 7 (pm) | Upon final PK data analysis, it was evident based upon Day 7 (pm) profiles that WAY-141624 did not have concentration-time data in the terminal phase for Day 1 (am) due to the limited time frame of the dosing intervals of 10 hours. Therefore, t1/2, planned for Day 1 AM, was unable to be calculated due to insufficient sampling duration prior to the PM dose. Missing values and substantial deviations meant results were excluded from subjects at various time points. | hours | GEOMETRIC_MEAN |
| PRIMARY | Terminal Elimination Phase Half-life (t1/2) of WAY-138451 in ADPKD Patients | Day 1 (am) and Day 7 (pm) | It was evident WAY-138451 did not have concentration-time data in the terminal phase for D1(am) due to the limited time frame of the 10-hour dosing intervals. t1/2, planned for Day 1 AM, was unable to be calculated due to insufficient sampling duration prior to the PM dose. Missing values, substantial deviations and \<3 quantifiable postdose WAY-138451 concentrations meant some results were excluded; also, t1/2 could not be calculated for the 2 participants in the low dose lixivaptan/CKD3 cohort. | hours | GEOMETRIC_MEAN |
| PRIMARY | Terminal Elimination Phase Half-life (t1/2) of WAY-138758 in ADPKD Patients | Day 1 (am) and Day 7 (pm) | Upon final PK data analysis, it was evident based upon Day 7 (pm) profiles that WAY-138758 did not appear to have concentration-time data in the terminal phase for Day 1 (am) due to the limited time frame of the dosing intervals of 10 hours. Therefore, t1/2, planned for Day 1 (am), was unable to be calculated due to insufficient sampling duration prior to the PM dose. Missing values and substantial deviations meant additional results were excluded from subjects at various time points. | hours | GEOMETRIC_MEAN |
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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