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Individualization of Dosage Regimens in Obese Patients: Application to Acyclovir

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: t
View:

• healthy volunteers with a BMI between 18 and 39,9 kg/m2, divided into 4 groups: 5 non-obese volunteers (BMI between 18 and 24,9 kg/m2), 5 overweight volunteers (BMI between 25 and 29,9 kg/m2), 5 volunteers with grade 1 obesity (BMI between 30 and 34,9 kg/m2) and 5 volunteers with grade 2 obesity (BMI between 35 and 39,9 kg/m2),

• volunteers with a aGFR \> 50 ml/min,

• with a good venous pathway for kinetics,

• women on contraception or postmenopausal women,

• person who has given written consent and affiliated with the public health insurance.

Locations
Other Locations
France
Toulouse Hospital
RECRUITING
Toulouse
Contact Information
Primary
Sarah Baklouti, PharmD
baklouti.s@chu-toulouse.fr
05 67 69 03 83
Backup
Charline DAGUZAN
daguzan.c@chu-toulouse.fr
05 61 77 84 90
Time Frame
Start Date: 2024-04-09
Estimated Completion Date: 2026-12
Participants
Target number of participants: 20
Treatments
Experimental: acyclovir
Subjects take a single dose of 5 mg/kg infused over 1 hour.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Toulouse

This content was sourced from clinicaltrials.gov