Limits...
Population Pharmacokinetics of Isavuconazole in Subjects with Mild or Moderate Hepatic Impairment.

Desai A, Schmitt-Hoffmann AH, Mujais S, Townsend R - Antimicrob. Agents Chemother. (2016)

Bottom Line: The mean clearance values for subjects with mild and moderate hepatic impairment decreased approximately to 1.55 liters/h (5th and 95th percentiles: 1.3 and 1.8 liters/h) and 1.32 liters/h (5th and 95th percentiles: 1.05 and 1.35), respectively.Peripheral volume of distribution increased with body mass index.After administration of the single dose, safety data for subjects with mild and moderate hepatic impairment were generally comparable to those for healthy subjects in both studies.

View Article: PubMed Central - PubMed

Affiliation: Astellas Pharma Global Development, Inc., Northbrook, Illinois, USA amit.desai@astellas.com.

No MeSH data available.


Related in: MedlinePlus

Mean simulated isavuconazole concentrations (with 95% confidence intervals) as a function of time.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC4862513&req=5

Figure 3: Mean simulated isavuconazole concentrations (with 95% confidence intervals) as a function of time.

Mentions: Monte Carlo simulations were performed by using population estimates from the best covariate model. A total of 2,000 total isavuconazole concentration-time profiles were simulated to steady state for healthy subjects and subjects with mild and moderate hepatic impairment. The BMI values were randomly added based on values found in NHANES database (2014), with subjects between the ages of 18 and 65 years selected. The concentration-time profile was simulated using the clinical dosing regimen. Simulations showed less than a 2-fold increase in mean trough isavuconazole concentrations for subjects with both mild and moderate hepatic impairment compared with healthy subjects administered the clinical dose of isavuconazole at steady state. The mean simulated trough concentrations are presented in Fig. 3, and the summary of trough concentrations is presented in Table 5.


Population Pharmacokinetics of Isavuconazole in Subjects with Mild or Moderate Hepatic Impairment.

Desai A, Schmitt-Hoffmann AH, Mujais S, Townsend R - Antimicrob. Agents Chemother. (2016)

Mean simulated isavuconazole concentrations (with 95% confidence intervals) as a function of time.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4862513&req=5

Figure 3: Mean simulated isavuconazole concentrations (with 95% confidence intervals) as a function of time.
Mentions: Monte Carlo simulations were performed by using population estimates from the best covariate model. A total of 2,000 total isavuconazole concentration-time profiles were simulated to steady state for healthy subjects and subjects with mild and moderate hepatic impairment. The BMI values were randomly added based on values found in NHANES database (2014), with subjects between the ages of 18 and 65 years selected. The concentration-time profile was simulated using the clinical dosing regimen. Simulations showed less than a 2-fold increase in mean trough isavuconazole concentrations for subjects with both mild and moderate hepatic impairment compared with healthy subjects administered the clinical dose of isavuconazole at steady state. The mean simulated trough concentrations are presented in Fig. 3, and the summary of trough concentrations is presented in Table 5.

Bottom Line: The mean clearance values for subjects with mild and moderate hepatic impairment decreased approximately to 1.55 liters/h (5th and 95th percentiles: 1.3 and 1.8 liters/h) and 1.32 liters/h (5th and 95th percentiles: 1.05 and 1.35), respectively.Peripheral volume of distribution increased with body mass index.After administration of the single dose, safety data for subjects with mild and moderate hepatic impairment were generally comparable to those for healthy subjects in both studies.

View Article: PubMed Central - PubMed

Affiliation: Astellas Pharma Global Development, Inc., Northbrook, Illinois, USA amit.desai@astellas.com.

No MeSH data available.


Related in: MedlinePlus