Clinical trial

Individualization of Dosage Regimens in Obese Patients: Application to Acyclovir

Recruiting now · Phase 1 · 1 countries · Registry ID NCT05589688

Recruiting nowPhase 1Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 50 Years

SexAll

Healthy volunteersAccepted

ConditionObesity

Full registry criteria

Inclusion Criteria: * 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. Exclusion Criteria: * volunteers with nephrotoxic co-prescriptions and/or co-prescriptions that would modify the pharmacokinetics of acyclovir like diuretics, NSAIDs or statins, * having presented serious allergies to a drug (e.g. angioedema...), with large parenchyma insufficiencies (e.g., hepatic insufficiency, heart failure...), * with diabetes or taking anti-diabetics due to the possible deterioration of renal function in diabetic patients, * with arterial hypertension or taking antihypertensive drugs due to the possible modification of renal clearance by modification of blood flow, * drug interactions with acyclovir (H2 receptor antagonists (e.g., Cimetidine), Probenecid, Mycophenolate Mofetil, Lithium, Anti-calcineurins (Ciclosporin, Tacrolimus)), * volunteers taking anticoagulants, * hypersensitivity to acyclovir, * pregnant woman, * participation in another clinical study in the last two months * volunteers with ongoing viral HSV/VZV infection treated with acyclovir, * adults under guardianship or other legal protection, deprived of their liberty by judicial or administrative decision

Treatments and study arms

Acyclovir

Drug

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

Primary outcomes

Renal elimination clearanceDay 1

To quantify the relationship between lean body mass, measured by Dual-energy x-ray absorptiometry (DEXA), and the true absolute glomerular filtration rate (GFRa) which is estimated by the renal elimination clearance of acyclovir.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Toulouse Hospital🇫🇷 Toulouse, France

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Guillaume MARTIN BLONDEL, MDContact