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Antifungal

Fluconazole for Vascular Response in Healthy Subjects

Phase 4
Recruiting
Led By Jeremy M Kellawan, PhD
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Individuals free of cardiovascular disease and metabolic disease
Women that are premenopausal with a regular menstrual cycle (26-30 days)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 hours
Awards & highlights

Study Summary

This trial is testing whether or not a certain kind of molecule contributes to how our veins and arteries respond to increased activity of the sympathetic nervous system. This could help explain why some diseases are characterized by increased sympathetic nerve activity and poor health outcomes, and potentially lead to new ways to treat these diseases.

Who is the study for?
This trial is for healthy individuals with a BMI under 30, no cardiovascular or metabolic diseases, premenopausal women with regular cycles, and normal blood pressure. It excludes pregnant people, those on certain medications like Amiodarone or S-warfarin, hormone replacement therapy users, smokers/tobacco users within the last 6 months, and anyone on cardiometabolic meds.Check my eligibility
What is being tested?
The study tests if Fluconazole (150 mg) affects how blood vessels respond to increased nerve activity that causes them to narrow. This response will be observed at rest and during exercise using a technique called lower body negative pressure in healthy participants.See study design
What are the potential side effects?
Fluconazole can cause headaches, nausea, stomach pain, dizziness and sometimes more serious effects like liver problems or allergic reactions. The likelihood of side effects varies from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have heart or metabolic diseases.
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I am a premenopausal woman with a regular menstrual cycle.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Near-Infrared Spectroscopy
Transcranial Doppler Ultrasound
Secondary outcome measures
Finger photoplethysmography
Wireless electrocardiogram

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: fluconazoleExperimental Treatment1 Intervention
fluconazole tablet/pill 150 mg, single acute dose
Group II: PlaceboPlacebo Group1 Intervention
250 mg pill microcrystalline Cellulose, single acute dose

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor
455 Previous Clinical Trials
97,583 Total Patients Enrolled
Jeremy M Kellawan, PhDPrincipal InvestigatorUniversity of Oklahoma
1 Previous Clinical Trials

Media Library

Fluconazole (Antifungal) Clinical Trial Eligibility Overview. Trial Name: NCT05176379 — Phase 4
Healthy Subjects Research Study Groups: Placebo, fluconazole
Healthy Subjects Clinical Trial 2023: Fluconazole Highlights & Side Effects. Trial Name: NCT05176379 — Phase 4
Fluconazole (Antifungal) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05176379 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the eligibility requirements for participation in this clinical trial?

"The enrolment criteria for this trial demands that healthy subjects aged 18 - 30 should have no autonomic dysfunction, cardiovascular disease, or metabolic illness. Additionally, female applicants must be premenopausal with a typical menstrual cycle (26-30 days) and body mass index of under 30 kg/m²."

Answered by AI

Is the age requirement for this research study restricted to individuals aged 18 or older?

"To be accepted into this trial, patients must fall between the ages of 18 to 30. Subsequently, there are 51 studies accommodating people under 18 and 379 trials for elderly individuals over 65 years old."

Answered by AI

Are there any available spaces for prospective participants in this clinical experiment?

"Affirmative. According to information on clinicaltrials.gov, this research is still in search of participants that it initially posted for recruitment on February 19th 2022 and recently updated on May 16th 2022. 30 people are needed from 1 centre."

Answered by AI

What health hazards have been linked to Fluconazole 150 mg dosages?

"The Fluconazole 150 mg was rated a 3 on our 1 to 3 scale, indicating its approval and the existence of prior data that supports its safety."

Answered by AI

In what medical circumstances is Fluconazole 150 mg typically recommended?

"Fluconazole 150 mg is traditionally prescribed to treat bone marrow transplantation, but it can also be used therapeutically for conditions such as candida intertrigo, HIV and candidiasis."

Answered by AI

Could you tell me the capacity of participants for this clinical investigation?

"Yes, the information on clinicaltrials.gov indicates that this trial is actively enrolling participants. The research was posted online on February 19th 2022 and last modified May 16th of the same year. This study requires 30 test subjects from one medical facility to participate."

Answered by AI

Is this the inaugural attempt at conducting such a clinical trial?

"Fluconazole 150 mg has been the subject of numerous studies since its initial trial in 2019, which was sponsored by Gilead Sciences. After successful completion of Phase 2 & 3 trials, 10 active clinical experiments are now taking place throughout 11 nations and 24 cities."

Answered by AI

Who else is applying?

What site did they apply to?
Department of Health and Exercise Science
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Endothelial Derived Hyperpolarization Factor and Vascular Control
Jeremy Mikhail Kellawan 2022. "Endothelial Derived Hyperpolarization Factor and Vascular Control". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05176379.
~1 spots leftby Jun 2024
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