NCT05589688RecruitingPhase 1
Individualization of Dosage Regimens in Obese Patients: Application to Acyclovir
Source: ClinicalTrials.gov · Last updated 31 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 17 Oct 2022
- Start date
- 9 Apr 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- University Hospital, Toulouse
- Diseases
- Obesity
- NCT number
- NCT05589688
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 20
- From 9 Apr 2024 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- drug interactions with acyclovir (H2 receptor antagonists (e.g., Cimetidine), Probenecid, Mycophenolate Mofetil, Lithium, Anti-calcineurins (Ciclosporin, Tacrolimus)),
- volunteers with ongoing viral HSV/VZV infection treated with acyclovir,
Other illness
- 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,
- hypersensitivity to acyclovir,
Lab values
- with arterial hypertension or taking antihypertensive drugs due to the possible modification of renal clearance by modification of blood flow,
Other
- volunteers with nephrotoxic co-prescriptions and/or co-prescriptions that would modify the pharmacokinetics of acyclovir like diuretics, NSAIDs or statins,
- volunteers taking anticoagulants,
- pregnant woman,
- participation in another clinical study in the last two months
- adults under guardianship or other legal protection, deprived of their liberty by judicial or administrative decision
Who the study is looking for
- 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.
Age in the registry: 18 years to 50 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Toulouse Hospital Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.