MedDataX Logo

Drug Concentration Analysis of Micafungin in Overweight, Obese, and Extremely Obese Volunteers

NCT ID: NCT01090141

Last Updated: 2020-11-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to assess the drug concentration of Micafungin amongst healthy volunteers having different weight groups.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Nutrition Disorders Overweight

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Micafungin Body Weight Anti-Infective Agents Signs and Symptoms Mycoses Therapeutic Uses Antifungal Agents Overnutrition Pharmacologic Actions

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Subjects recieving 100 mg of Micafungin

Group Type ACTIVE_COMPARATOR

Micafungin

Intervention Type DRUG

100 mg IV infusion over 1 hour

Subjects recieving 300 mg of Micafungin

Group Type ACTIVE_COMPARATOR

Micafungin

Intervention Type DRUG

300 mg IV infusion over 1 hour

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Micafungin

100 mg IV infusion over 1 hour

Intervention Type DRUG

Micafungin

300 mg IV infusion over 1 hour

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male and female subjects
* 18 years or older
* All racial and ethnic origins
* English or Spanish speaking

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Astellas Pharma US, Inc.

INDUSTRY

Sponsor Role collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tawanda Gumbo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas, Southwestern Medical Center at Dallas

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BJ-07-003

Identifier Type: -

Identifier Source: org_study_id