Trial · NCT04665037
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Average concentration (Cavg) of single-dose IV POS (Panel A) | Predose, 0.25 and 24 hours post-infusion on Day 1 | The Cavg of IV POS is based on population PK analysis. |
| Primary | Maximum concentration (Cmax) of single-dose IV POS (Panel A) | Predose, 0.25 and 24 hours post-infusion on Day 1 | The Cmax of IV POS is based on population PK analysis. |
| Primary | Time to maximum concentration (Tmax) of single-dose IV POS (Panel A) | Predose, 0.25 and 24 hours post-infusion on Day 1 | The Tmax of IV POS is based on population PK analysis. |
| Primary | Area under the plasma concentration-time curve from dosing to 24 hours postdose (AUC0-24) of single-dose IV POS (Panel A) | Predose, 0.25 and 24 hours post-infusion on Day 1 | The AUC 0-24 of IV POS is based on population PK analysis. |
| Primary | Clearance (CL) of single-dose IV POS (Panel A) | Predose, 0.25 and 24 hours post-infusion on Day 1 | The clearance (CL) of IV POS is based on population PK analysis. |
| Primary | Area under the plasma concentration-time curve from dosing to infinity (AUC0-∞) of single-dose IV POS (Panel A) | Predose, 0.25 and 24 hours post-infusion on Day 1 | The AUC0-∞ of IV POS is based on population PK analysis. |
| Primary | Cavg of multiple-dose IV POS (Panel B) | Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12 | The Cavg of IV POS is based on population PK analysis. |
| Primary | Cmax of multiple-dose IV POS (Panel B) | Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12 | The Cmax of IV POS is based on population PK analysis. |
| Primary | Tmax of multiple-dose IV POS (Panel B) | Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12 | The Tmax of IV POS is based on population PK analysis. |
| Primary | AUC0-24 of multiple-dose IV POS (Panel B) | Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12 | The AUC0-24 of IV POS is based on population PK analysis. |
| Primary | CL of multiple-dose IV POS (Panel B) | Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12 | The CL of IV POS is based on population PK analysis. |
| Primary | Cavg of multiple-dose PFS POS (Panel B) | Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12 | The Cavg of PFS POS is based on population PK analysis. |
| Primary | Cmax of multiple-dose PFS POS (Panel B) | Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12 | The Cmax of PFS POS is based on population PK analysis. |
| Primary | AUC0-24 of multiple-dose PFSPOS (Panel B) | Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12 | The AUC0-24 of PFS POS is based on population PK analysis. |
| Secondary | Cavg of IV POS in neonates and infants <2 years of age compared to adults and older pediatric populations (Panel B) | Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12 | The Cavg of IV POS is based on population PK analysis. Comparisons between participants in Panel B will be made to data that was previously collected in older participants. |
| Secondary | Percentage of participants with an ≥ 1 adverse event (AE) [Panels A and B] | Up to 98 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
| Secondary | Percentage of participants who discontinued study therapy due to an AE (Panels A and B) | Up to 84 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
| Secondary | Percentage of participants with a drug-related AE (Panels A and B) | Up to 98 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
| Secondary | Percentage of participants with all-cause mortality (ACM) [Panel B] | Up to 28 days | The percentage of participants with ACM will be reported. |
| Secondary | Percentage of participants with need for systemic antifungal therapy (other than POS) during the study period (Panel B) | Up to 84 days | Percentage of participants who received additional antifungal therapy in Panel B will be reported. |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04665037/registered