Clinical Research Directory
Browse clinical research sites, groups, and studies.
Individualization of Dosage Regimens in Obese Patients: Application to Acyclovir
Sponsor: University Hospital, Toulouse
Summary
The number of obese people will reach 50% of the world population by 2035. Obesity is a chronic disease. For obese patients, dosage regimens have been determined for patients with a "normal" BMI between 20-30 kg/m2. Based on plasma and urine concentrations, a pharmacokinetic model will be performed to study in healthy volunteers, the predictive character of lean mass, measured by DEXA, on renal elimination and therefore on acyclovir exposure. The main objective of this study is to evaluate, in 4 volunteers groups representative of (1) non-obese (18-24.9 kg/m2), (2) overweight (25-29.9 kg/m2), (3) grade 1 obesity (30-34.9 kg/m2) and (4) grade 2 obesity (35-39.9 kg/m2), the predictive nature of lean mass, measured by DEXA, on renal elimination and therefore on acyclovir exposure.
Key Details
Gender
All
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2024-04-09
Completion Date
2026-12
Last Updated
2025-12-31
Healthy Volunteers
Yes
Conditions
Interventions
Acyclovir
Subjects will receive a single dose of 5 mg/kg infused over 1 hour. Then, 13 blood samples after placement of a catheter, and 4 urine samples will be taken over the 12 hours following the start of administration
Locations (1)
Toulouse Hospital
Toulouse, France