Individualization of Dosage Regimens in Obese Patients: Application to Acyclovir

NCT05589688 | Recruiting Phase 1

• 1 other identifier: RC31/21/0610
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Renal elimination clearance

  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.

  Day 1

Secondary Outcomes (3)

• the interindividual variability of acyclovir exposure : lean mass

  Day 1

• the interindividual variability of acyclovir exposure : glomerular filtration rate

  Day 1

• the qualitative compilation of adverse events associated with acyclovir infusion observed and reported by the volunteer.

  Day 1, Day 2

Study Arms (1)

acyclovir

EXPERIMENTAL

Subjects take a single dose of 5 mg/kg infused over 1 hour.

Drug: Acyclovir

Interventions

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

acyclovir

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Toulouse Hospital

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Acyclovir

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sarah Baklouti, PharmD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Baklouti, PharmD

CONTACT

05 67 69 03 83; baklouti.s@chu-toulouse.fr

Charline DAGUZAN

CONTACT

05 61 77 84 90; daguzan.c@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 21, 2022
• Study Start: April 9, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)