Trial · NCT01430169
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | AUX-I Cmax After Injection 1 | 15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1) | Pharmacokinetic (PK) population (N=19). Two subjects were excluded from the analysis due to bioanalytical reasons (ELISA interference) | ng/mL | MEAN |
| PRIMARY | AUX-II Cmax After Injection 1 | 15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1) | Pharmacokinetic (PK) population (N=19). | ng/mL | MEAN |
| PRIMARY | AUX-I AUC0-tlast After Injection 1 | 15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1) | Pharmacokinetic population (N=19). Two subjects were excluded from the analysis due to bioanalytical reasons (ELISA interference) | ng*h/mL | MEAN |
| PRIMARY | AUX-II AUC0-tlast After Injection 1 | 15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1) | Pharmacokinetic (PK) population (N=19) | ng*h/mL | MEAN |
| PRIMARY | AUX-I Tmax After Injection 1 | 15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1) | Pharmacokinetic (PK) population (N=19). For 3 subjects Tmax was considered missing if concentration was BLQ for all time points at that injection and 2 subjects were excluded from the analysis due to bioanalytical reasons (ELISA interference) | hours | MEAN |
| PRIMARY | AUX-II Tmax After Injection 1 | 15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1) | Pharmacokinetic (PK) population (N=19) One subject was excluded from AUX-II PK analyses due to insufficient quantities of plasma for bioanalysis. Of the 38 AUX-II profiles, 23 had no quantifiable plasma concentrations at any time point through 24 hours post injection. | hours | MEAN |
| PRIMARY | AUX-I Cmax After Injection 2 | 15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2) | Pharmacokinetic (PK) population (N=19). Two subjects were excluded from the analysis due to bioanalytical reasons (ELISA interference) | ng/mL | MEAN |
| PRIMARY | AUX-II Cmax After Injection 2 | 15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2) | Pharmacokinetic (PK) population (N=19) | ng/mL | MEAN |
| PRIMARY | AUX-I AUC0-tlast After Injection 2 | 15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2) | Pharmacokinetic (PK) population (N=19). Two subjects were excluded from the analysis due to bioanalytical reasons (ELISA interference) | ng*h/mL | MEAN |
| PRIMARY | AUX-II AUC0-tlast After Injection 2 | 15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2) | Pharmacokinetic (PK) population (N=19) | ng*h/mL | MEAN |
| PRIMARY | AUX-I Tmax After Injection 2 | 15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2) | Pharmacokinetic (PK) population (N=19). In addition, 2 subjects have been excluded from the analysis due to ELISA interference.~Of the 38 AUX-I profiles, 7 had no quantifiable plasma concentrations through 24 hours post injection. | hour | MEAN |
| PRIMARY | AUX-II Tmax After Injection 2 | 15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2) | Pharmacokinetic (PK) population (N=19) In addition, 2 subjects have been excluded from the analysis due to ELISA interference. Of the 38 AUX-II profiles,23 had no quantifiable plasma concentrations at any time point through 24 hours post injection. | hours | 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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Read this list from software.
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