ObesityPhase 4MicafunginNCT01090141
Drug Concentration Analysis of Micafungin in Overweight, Obese, and Extremely Obese Volunteers
A Phase 4 study testing Micafungin in people with Obesity and Nutrition Disorders, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to assess the drug concentration of Micafungin amongst healthy volunteers having different weight groups. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Nutrition Disorders, Overweight
- What is being tested?
- Micafungin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Jun 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects
- 18 years or older
- All racial and ethnic origins
- English or Spanish speaking
Who cannot join
- Pregnant or nursing or unwilling to use a reliable contraception method during the study. The effects of micafungin on pregnancy are unknown. In addition, the metabolic changes that accompany pregnancy may alter the concentration-time profile of micafungin, so that the pregnancy and post-partum state would be a confounding variable.
- Abnormal liver function tests: transaminases>10 times upper limit of normal, Alkaline phosphatase>5 times upper limit of normal, total bilirubin>5 times upper limit of normal.
- Creatinine Clearance < 70 ml/min as estimated by the Cockcroft-Gault equation
- History of allergies to echinocandins
- Echinocandins are contraindicated for any reason
- Volunteers unwilling to comply with study procedures.
- Suspected or documented systemic fungal infection.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: Pharmacokinetic Analysis of Micafungin in Overweight, Obese, and Extremely Obese Volunteers
The purpose of this study is to assess the drug concentration of Micafungin amongst healthy volunteers having different weight groups.
Read the detailed description
This is a single center study. A total of 36 adult volunteers will be consented for the study. Volunteers will be admitted for an overnight stay. Half will be female and half male. Twelve volunteers will have a body mass index (BMI) less than 25 kg/m2, 12 will have a BMI 25-40 kg/m2, and 12 will have a BMI greater than 40 kg/m2. Volunteers will have height and weight measured after they have consented to participate. Exactly half the volunteers in each category will received a single dose of intravenous micafungin of 100 mg, while the other half will receive 300 mg as determined by a coin flip. The volunteers will have blood drawn via an intravenous catheter just prior to the dose, and then at 1, 4, 8, 12, 16, and 24h after the drug dose. The intravenous catheter is then removed after the 24h blood draw, and the volunteer discharged from the study. Compensation will be provided to the participants for their time.
- Conditions
- Obesity, Nutrition Disorders, Overweight
- Being tested
- Micafungin
- Keywords
- Micafungin, Body Weight, Anti-Infective Agents, Signs and Symptoms, Mycoses, Therapeutic Uses, Antifungal Agents, Overnutrition, Pharmacologic Actions
- Medical subject headings
- Obesity, Nutrition Disorders, Overweight, Body Weight, Signs and Symptoms, Mycoses, Overnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicafunginDrug
100 mg IV infusion over 1 hour
MicafunginDrug
300 mg IV infusion over 1 hour
| Study group | Role | What they receive |
|---|---|---|
| Subjects recieving 100 mg of Micafungin | Active comparator | Not described Receives: Drug: Micafungin |
| Subjects recieving 300 mg of Micafungin | Active comparator | Not described Receives: Drug: Micafungin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Clearance of Micafungin
Measured: 0-24 Hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2010 (estimated)
- Study startNov 2009
- Primary completionMay 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma US, Inc.
- Responsible party
- Sponsor
- Investigators
- Tawanda Gumbo, MD, Principal investigator, University of Texas, Southwestern Medical Center at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01090141
- Sponsor's protocol ID
- BJ-07-003
- Acronym
- Micafungin
- Status last verified
- Nov 2020
- First submitted
- 17 Mar 2010
- Last updated
- 27 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Analysis of Micafungin in Overweight, Obese, and Extremely Obese Volunteers
- ClinicalTrials.gov ID
- NCT01090141
- Acronym / sponsor ID
- Micafungin / BJ-07-003
- Conditions
- Obesity, Nutrition Disorders, Overweight
- Keywords
- Micafungin, Body Weight, Anti-Infective Agents, Signs and Symptoms, Mycoses, Therapeutic Uses, Antifungal Agents, Overnutrition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Astellas Pharma US, Inc.
- Study start
- Nov 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 19 Mar 2010 (estimated)
- Results
- Posted 27 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the drug concentration of Micafungin amongst healthy volunteers having different weight groups.
Detailed description
This is a single center study. A total of 36 adult volunteers will be consented for the study. Volunteers will be admitted for an overnight stay. Half will be female and half male. Twelve volunteers will have a body mass index (BMI) less than 25 kg/m2, 12 will have a BMI 25-40 kg/m2, and 12 will have a BMI greater than 40 kg/m2. Volunteers will have height and weight measured after they have consented to participate. Exactly half the volunteers in each category will received a single dose of intravenous micafungin of 100 mg, while the other half will receive 300 mg as determined by a coin flip. The volunteers will have blood drawn via an intravenous catheter just prior to the dose, and then at 1, 4, 8, 12, 16, and 24h after the drug dose. The intravenous catheter is then removed after the 24h blood draw, and the volunteer discharged from the study. Compensation will be provided to the participants for their time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects recieving 100 mg of Micafungin | Active comparator | Drug: Micafungin |
| Subjects recieving 300 mg of Micafungin | Active comparator | Drug: Micafungin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female subjects
- 18 years or older
- All racial and ethnic origins
- English or Spanish speaking
Key exclusion criteria (7 listed)
- Pregnant or nursing or unwilling to use a reliable contraception method during the study. The effects of micafungin on pregnancy are unknown. In addition, the metabolic changes that accompany pregnancy may alter the concentration-time profile of micafungin, so that the pregnancy and post-partum state would be a confounding variable.
- Creatinine Clearance < 70 ml/min as estimated by the Cockcroft-Gault equation
- History of allergies to echinocandins
- Echinocandins are contraindicated for any reason
- Volunteers unwilling to comply with study procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micafungin100 mg IV infusion over 1 hour | Drug | Subjects recieving 100 mg of Micafungin |
| Micafungin300 mg IV infusion over 1 hour | Drug | Subjects recieving 300 mg of Micafungin |
Primary outcome
Serum Clearance of Micafungin
Time frame: 0-24 Hrs
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tawanda Gumbo, MD principal investigator
University of Texas, Southwestern Medical Center at Dallas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Micafungin in people with Obesity and Nutrition Disorders, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Clearance of Micafungin (time frame: 0-24 Hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2020.