NCT05589688 Individualization of Dosage Regimens in Obese Patients: Application to Acyclovir
| NCT ID | NCT05589688 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University Hospital, Toulouse |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-04-09 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2024-04-09 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Sarah Baklouti, PharmD
PRINCIPAL INVESTIGATOR
University Hospital, Toulouse
Frequently Asked Questions
Who can join the NCT05589688 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05589688 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05589688 currently recruiting?
Yes, NCT05589688 is actively recruiting participants. Contact the research team at baklouti.s@chu-toulouse.fr for enrollment information.
Where is the NCT05589688 trial being conducted?
This trial is being conducted at Toulouse, France.
Who is sponsoring the NCT05589688 clinical trial?
NCT05589688 is sponsored by University Hospital, Toulouse. The principal investigator is Sarah Baklouti, PharmD at University Hospital, Toulouse. The trial plans to enroll 20 participants.
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