Trial · NCT03487913
Registered outcomes55
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 55
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Observed Plasma Concentration (Cmax) of Lixivaptan in ADPKD Patients | Day 1 (am and pm) and Day 7 (am and pm) | The pharmacokinetic parameter Cmax, the highest concentration of lixivaptan measured in plasma after multiple doses of drug, will be calculated from the observed concentration of lixivaptan and summarized by cohort. |
| Primary | Maximum Observed Plasma Concentration (Cmax) of WAY-141624 in ADPKD Patients | Day 1 (am and pm) and Day 7 (am and pm) | The pharmacokinetic parameter Cmax, the highest concentration of WAY-141624 measured in plasma after multiple doses of drug, will be calculated from the observed concentration of WAY-141624 and summarized by cohort. |
| Primary | Maximum Observed Plasma Concentration (Cmax) of WAY-138451 in ADPKD Patients | Day 1 (am and pm) and Day 7 (am and pm) | The pharmacokinetic parameter Cmax, the highest concentration of WAY-138451 measured in plasma after multiple doses of drug, will be calculated from the observed concentration of WAY-138451 and summarized by cohort. |
| Primary | Maximum Observed Plasma Concentration (Cmax) of WAY-138758 in ADPKD Patients | Day 1 (am and pm) and Day 7 (am and pm) | The pharmacokinetic parameter Cmax, the highest concentration of WAY-138758 measured in plasma after multiple doses of drug, will be calculated from the observed concentration of WAY-138758 and summarized by cohort. |
| 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 pharmacokinetic parameter tmax, the time taken to reach the highest concentration of lixivaptan in plasma after multiple doses of drug, will be calculated from the observed concentration of lixivaptan and summarized by cohort. |
| 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 pharmacokinetic parameter tmax, the time taken to reach the highest concentration of WAY-141624 in plasma after multiple doses of drug, will be calculated from the observed concentration of WAY-141624 and summarized by cohort. |
| 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 pharmacokinetic parameter tmax, the time taken to reach the highest concentration of WAY-138451 in plasma after multiple doses of drug, will be calculated from the observed concentration of WAY-138451 and summarized by cohort. |
| 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 pharmacokinetic parameter tmax, the time taken to reach the highest concentration of WAY-138758 in plasma after multiple doses of drug, will be calculated from the observed concentration of WAY-138758 and summarized by cohort. |
| 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 pharmacokinetic parameter AUC(0-last) for lixivaptan will be calculated using the linear trapezoidal rule for increasing values and the log trapezoidal rule for decreasing values, summarized by cohort. |
| 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 pharmacokinetic parameter AUC(0-last) for WAY-141624 will be calculated using the linear trapezoidal rule for increasing values and the log trapezoidal rule for decreasing values and summarized by cohort. |
| 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 pharmacokinetic parameter AUC(0-last) for WAY-138451 will be calculated using the linear trapezoidal rule for increasing values and the log trapezoidal rule for decreasing values and summarized by cohort. |
| 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 pharmacokinetic parameter AUC(0-last) for WAY-138758 will be calculated using the linear trapezoidal rule for increasing values and the log trapezoidal rule for decreasing values and summarized by cohort. |
| Primary | Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf]) of Lixivaptan in ADPKD Patients | Day 1 (am) | The pharmacokinetic parameter AUC(0-inf) for lixivaptan will be calculated using the linear trapezoidal rule for increasing values, the log trapezoidal rule for decreasing values, and extrapolated to infinity by addition of the last quantifiable observed concentration divided by the elimination rate constant and summarized by cohort. |
| 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) | The pharmacokinetic parameter AUC(0-inf) for WAY-141624 will be calculated using the linear trapezoidal rule for increasing values, the log trapezoidal rule for decreasing values, and extrapolated to infinity by addition of the last quantifiable observed concentration divided by the elimination rate constant and summarized by cohort. |
| 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) | The pharmacokinetic parameter AUC(0-inf) for WAY-138451 will be calculated using the linear trapezoidal rule for increasing values, the log trapezoidal rule for decreasing values, and extrapolated to infinity by addition of the last quantifiable observed concentration divided by the elimination rate constant and summarized by cohort. |
| 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) | The pharmacokinetic parameter AUC(0-inf) for WAY-138758 will be calculated using the linear trapezoidal rule for increasing values, the log trapezoidal rule for decreasing values, and extrapolated to infinity by addition of the last quantifiable observed concentration divided by the elimination rate constant and summarized by cohort. |
| Primary | Terminal Elimination Phase Half-life (t1/2) of Lixivaptan in ADPKD Patients | Day 1 (am) and Day 7 (pm) | The pharmacokinetic parameter t1/2 for lixivaptan, determined as ln2/apparent terminal elimination rate constant, will be calculated and summarized by cohort. |
| Primary | Terminal Elimination Phase Half-life (t1/2) of WAY-141624 in ADPKD Patients | Day 1 (am) and Day 7 (pm) | The pharmacokinetic parameter t1/2 for WAY-141624, determined as ln2/apparent terminal elimination rate constant, will be calculated and summarized by cohort. |
| Primary | Terminal Elimination Phase Half-life (t1/2) of WAY-138451 in ADPKD Patients | Day 1 (am) and Day 7 (pm) | The pharmacokinetic parameter t1/2 for WAY-138451, determined as ln2/apparent terminal elimination rate constant, will be calculated and summarized by cohort. |
| Primary | Terminal Elimination Phase Half-life (t1/2) of WAY-138758 in ADPKD Patients | Day 1 (am) and Day 7 (pm) | The pharmacokinetic parameter t1/2 for WAY-138758, determined as ln2/apparent terminal elimination rate constant, will be calculated and summarized by cohort. |
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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