Trial · NCT03487913
Outcomes55
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
21 to 40 of 55
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Apparent Terminal Elimination Rate Constant (λZ) 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 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, λZ, 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. | 1/hour | GEOMETRIC_MEAN |
| PRIMARY | Apparent Terminal Elimination Rate Constant (λZ) 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 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, λZ, 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. | 1/hour | GEOMETRIC_MEAN |
| PRIMARY | Apparent Terminal Elimination Rate Constant (λZ) of WAY-138451 in ADPKD Patients | Day 1 (am) and Day 7 (pm) | It was evident WAY-138451 did not appear to have concentration-time data in the terminal phase for D1(am) due to the limited time frame of the dosing intervals of 10 hours. λZ, planned for D1(am), was unable to be calculated due to insufficient sampling duration prior to the pm dose. Missing values, deviations, and \<3 quantifiable postdose WAY-138451 concentrations meant results were excluded; also, λZ could not be calculated for the 2 participants in the low dose lixivaptan/CKD3 cohort. | 1/hour | GEOMETRIC_MEAN |
| PRIMARY | Apparent Terminal Elimination Rate Constant (λZ) 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, λZ, 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. | 1/hour | GEOMETRIC_MEAN |
| PRIMARY | Apparent Systemic Clearance After Extravascular Dosing (CL/F) of Lixivaptan in ADPKD Patients | Day 1 (am) and Day 7 (am) | Upon final PK data analysis, it was evident based upon Day 7 (pm) profiles that lixivaptan 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, CL/F, 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. | L/hour | GEOMETRIC_MEAN |
| PRIMARY | Volume of Distribution After Extravascular Dosing (VZ/F) of Lixivaptan in ADPKD Patients | Day 1 (am) and Day 7 (am) | Upon final data analysis, it was evident based upon Day (D) 7(pm) profiles that lixivaptan 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. Therefore, VZ/F, planned for D1(am), was unable to be calculated due to insufficient sampling duration prior to the pm dose, and values for the D7(am) time point were not presented. Instead, VZ/F24H was determined and presented as an Other Pre-specified Outcome Measure. | L | GEOMETRIC_MEAN |
| PRIMARY | Accumulation Ratio for Cmax (RCmax) of Lixivaptan in ADPKD Patients | Day 7 (am) | Of the 31 subjects in the PKAS, 29 contributed data to Day 7 (am). | Ratio | GEOMETRIC_MEAN |
| PRIMARY | Accumulation Ratio for AUC(0-last) (RAUC[0-last]) of Lixivaptan in ADPKD Patients | Day 7 (am) | Of the 31 subjects in the PKAS, 29 contributed data to Day 7 (am). | Ratio | GEOMETRIC_MEAN |
| PRIMARY | Area Under the Concentration-time Curve From Time 0 Until 14 Hours Postdose (AUC[0-14]) of Lixivaptan in ADPKD Patients | Day 7 (pm) | Of the 31 subjects in the PKAS, 29 contributed data to Day 7 (pm). | ng*h/mL | GEOMETRIC_MEAN |
| PRIMARY | Area Under the Concentration-time Curve From Time 0 Until 14 Hours Postdose (AUC[0-14]) of WAY-141624 in ADPKD Patients | Day 7 (pm) | Of the 31 subjects in the PKAS, 29 contributed data to Day 7 (pm). | ng*h/mL | GEOMETRIC_MEAN |
| PRIMARY | Area Under the Concentration-time Curve From Time 0 Until 14 Hours Postdose (AUC[0-14]) of WAY-138451 in ADPKD Patients | Day 7 (pm) | Of the 31 subjects in the PKAS, 29 contributed data to Day 7 (pm). | ng*h/mL | GEOMETRIC_MEAN |
| PRIMARY | Area Under the Concentration-time Curve From Time 0 Until 14 Hours Postdose (AUC[0-14]) of WAY-138758 in ADPKD Patients | Day 7 (pm) | Of the 31 subjects in the PKAS, 29 contributed data to Day 7 (pm). | ng*h/mL | GEOMETRIC_MEAN |
| PRIMARY | Ratio of WAY-141624 Cmax to Parent Lixivaptan Cmax (MRCmax) in ADPKD Patients | Day 7 (pm) | Of the 31 subjects in the PKAS, 29 contributed data to Day 7 (pm). | Ratio | GEOMETRIC_MEAN |
| PRIMARY | Ratio of WAY-138451 Cmax to Parent Lixivaptan Cmax (MRCmax) in ADPKD Patients | Day 7 (pm) | Of the 31 subjects in the PKAS, 29 contributed data to Day 7 (pm). | Ratio | GEOMETRIC_MEAN |
| PRIMARY | Ratio of WAY-138758 Cmax to Parent Lixivaptan Cmax (MRCmax) in ADPKD Patients | Day 7 (pm) | Of the 31 subjects in the PKAS, 29 contributed data to Day 7 (pm). | Ratio | GEOMETRIC_MEAN |
| PRIMARY | Ratio of Metabolite AUC(0-14) to Parent Lixivaptan AUC(0-14) (MRAUC[0-14]) of WAY-141624 in ADPKD Patients | Day 7 (pm) | Of the 31 subjects in the PKAS, 29 contributed data to Day 7 (pm). | Ratio | GEOMETRIC_MEAN |
| PRIMARY | Ratio of Metabolite AUC(0-14) to Parent Lixivaptan AUC(0-14) (MRAUC[0-14]) of WAY-138451 in ADPKD Patients | Day 7 (pm) | Of the 31 subjects in the PKAS, 29 contributed data to Day 7 (pm). | Ratio | GEOMETRIC_MEAN |
| PRIMARY | Ratio of Metabolite AUC(0-14) to Parent Lixivaptan AUC(0-14) (MRAUC[0-14]) of WAY-138758 in ADPKD Patients | Day 7 (pm) | Of the 31 subjects in the PKAS, 29 contributed data to Day 7 (pm). | Ratio | GEOMETRIC_MEAN |
| PRIMARY | Number of Study Participants With Treatment-emergent Adverse Events | 35 days | Results are presented based on the Safety Analysis Set, which included all subjects who received at least 1 dose of study medication, and were analyzed according to treatment received. The Safety Analysis Set included all 31 subjects who were enrolled in the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Study Participants With Clinically Significant Physical Examination Findings | 35 days | Results are presented based on the Safety Analysis Set, which included all subjects who received at least 1 dose of study medication, and were analyzed according to treatment received. The Safety Analysis Set included all 31 subjects who were enrolled in the study. | 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.
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