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

• Sponsor: University of Texas Southwestern Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01090141
• Collaborator: Astellas Pharma US, Inc. (Industry)
• Enrollment: 36
• Location: 1
• Arms: 2
• Duration (Months): 7
• Patients Per Site Per Month: 5.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Obesity; Nutrition Disorders; Overweight	Drug: Micafungin; Drug: Micafungin	Phase 4

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

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pharmacokinetic Analysis of Micafungin in Overweight, Obese, and Extremely Obese Volunteers
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: May 1, 2010
• Actual Study Completion Date: Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Subjects recieving 100 mg of Micafungin	Drug: Micafungin; 100 mg IV infusion over 1 hour
Active Comparator: Subjects recieving 300 mg of Micafungin	Drug: Micafungin; 300 mg IV infusion over 1 hour

Outcome Measures

Primary Outcome Measures

1. Serum Clearance of Micafungin [0-24 Hrs]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas Southwestern Medical Center	Dallas	Texas	United States	75390

Sponsors and Collaborators

• University of Texas Southwestern Medical Center
• Astellas Pharma US, Inc.

Investigators

• Principal Investigator: Tawanda Gumbo, MD, University of Texas, Southwestern Medical Center at Dallas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT01090141
• Other Study ID Numbers: BJ-07-003
• First Posted: Mar 19, 2010
• Last Update Posted: Nov 27, 2020
• Last Verified: Nov 1, 2020

• Keywords provided by University of Texas Southwestern Medical Center: Micafungin; Body Weight; Anti-Infective Agents; Signs and Symptoms; Mycoses; Therapeutic Uses; Antifungal Agents; Overnutrition; Pharmacologic Actions
• Additional relevant MeSH terms: Nutrition Disorders; Overweight; Micafungin

Study Results

Participant Flow

Pre-assignment Detail

The PI (Tawanda Gumb) has left the institution. Since May 2020, we tried to locate original PI and reached out to two PRS administrators at Baylor, Texas Tech University where we believe the original PI is, but they have informed us PI is no longer there, and they do not know where data are for this study. Further efforts were made to locate manuscript, and study team members, but were unsuccessful. No study data are available

Arm/Group Title	Subjects Recieving 100 mg of Micafungin	Subjects Recieving 300 mg of Micafungin
Arm/Group Description	Micafungin: 100 mg IV infusion over 1 hour	Micafungin: 300 mg IV infusion over 1 hour
Period Title: Overall Study
STARTED	0	0
COMPLETED	0	0
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Subjects Recieving 100 mg of Micafungin	Subjects Recieving 300 mg of Micafungin	Total
Arm/Group Description	Micafungin: 100 mg IV infusion over 1 hour	Micafungin: 300 mg IV infusion over 1 hour	Total of all reporting groups
Overall Participants	0	0	0
Age () []
Sex: Female, Male () []
Female
Male
Region of Enrollment (participants) []

Outcome Measures

1. Primary Outcome

Title	Serum Clearance of Micafungin
Time Frame	0-24 Hrs

Outcome Measure Data

Analysis Population Description

The PI (Tawanda Gumb) has left the institution. Since May 2020, we tried to locate original PI and reached out to two PRS administrators at Baylor, Texas Tech University where we believe the original PI is, but they have informed us PI is no longer there, and they do not know where data are for this study. Further efforts were made to locate manuscript, and study team members, but were unsuccessful. No study data are available

Arm/Group Title	Subjects Recieving 100 mg of Micafungin	Subjects Recieving 300 mg of Micafungin
Arm/Group Description	Micafungin: 100 mg IV infusion over 1 hour	Micafungin: 300 mg IV infusion over 1 hour
Measure Participants	0	0

Adverse Events

Adverse Event Reporting Description	The PI (Tawanda Gumb) has left the institution.Since May 2020, we tried to locate original PI and reached out to two PRS administrators at Baylor, Texas Tech University where we believe the original PI is, but they have informed us PI is no longer there, and they do not know where data are for this study. Further efforts were made to locate manuscript, and study team members, but were unsuccessful. No study data are available
Arm/Group Title	Subjects Recieving 100 mg of Micafungin		Subjects Recieving 300 mg of Micafungin
Arm/Group Description	Micafungin: 100 mg IV infusion over 1 hour		Micafungin: 300 mg IV infusion over 1 hour
All Cause Mortality
	Subjects Recieving 100 mg of Micafungin		Subjects Recieving 300 mg of Micafungin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Subjects Recieving 100 mg of Micafungin		Subjects Recieving 300 mg of Micafungin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Subjects Recieving 100 mg of Micafungin		Subjects Recieving 300 mg of Micafungin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

The PI (Tawanda Gumb) has left the institution. Since May 2020, we tried to locate original PI and reached out to two PRS administrators at Baylor, Texas Tech University where we believe the original PI is, but they have informed us PI is no longer there, and they do not know where data are for this study. Further efforts were made to locate manuscript, and study team members, but were unsuccessful. No study data are available.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.