Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05589688
PHASE1

Individualization of Dosage Regimens in Obese Patients: Application to Acyclovir

Sponsor: University Hospital, Toulouse

View on ClinicalTrials.gov

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

DRUG

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