Blood samples for serum concentration analysis of LY3022855 were collected pre-dose on: Cycle 1 days 1, 8, 22, and 36; Cycle 2 day 1; Cycle 3 days 1, 8, and 22; Cycle 5 Day 1. Post-dose samples were collected at 1, 4, 24, and 48 hours on Cycle 1 Day 1 and Cycle 3 Day 1. Serum samples were analyzed for LY3022855 using a validated ELISA method at Covance Laboratories Inc. located in Chantilly, Virginia, USA. The lower limit of quantification was 1562.5 ng/mL, and the upper limit of quantification was 50,000 ng/mL. The inter-assay accuracy (% relative error) during validation ranged from −11.9% to 5.2%. The inter-assay precision (% relative standard deviation) during validation ranged from 6.8% to 17.5%. LY3022855 was stable for up to 558 days when stored at −70°C. Pharmacokinetic analyses were conducted on patients who had received ≥1 dose of LY3022855 and had venous blood samples collected. Pharmacokinetic parameters for LY3022855 were computed by standard non-compartmental methods of analysis using Phoenix WinNonlin® Version 8.
Phoenix winnonlin version 8
Manufactured by Phoenix Pharmaceuticals
Phoenix WinNonlin® Version 8 is a software product for pharmacokinetic and pharmacodynamic analysis. It provides tools for modeling and simulation of drug and biological molecule concentrations over time.
Automatically generated - may contain errors
Lab products found in correlation
2 protocols using phoenix winnonlin version 8
1
Pharmacokinetics of LY3022855 in Patients
2
Pharmacokinetic and Safety Study
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This was an exploratory study. The numbers of subjects per cohort are consistent with common practice for this study type and were considered suitable to achieve the study objectives. Descriptive statistics for safety data are presented as cases (%). PK parameters, Cmax, AUC, t1/2, CL or CL/F, Vd(area), and F are presented as arithmetic means with standard deviation (SD). Tmax is expressed as the median (range). Subject disposition (age and BMI) is presented as median (range). All statistical analyses were performed using SAS version 9.4 or higher (SAS Institute, Cary, North Carolina), and/or Phoenix WinNonlin version 8 software.
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