Obesity drug dosing mystery: can lean mass predict acyclovir needs?
NCT ID NCT05589688
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aims to improve how acyclovir is dosed in people with obesity. Researchers will measure lean body mass and kidney function in 20 healthy volunteers with different BMIs to see if these factors predict how the body clears the drug. The goal is to create better dosing guidelines for obese patients.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 50 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Toulouse Hospital
RECRUITINGToulouse, France
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