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

NCT01090141 | Completed Phase 4 Results DMC

• 1 other identifier: BJ-07-003
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity; Nutrition Disorders; Overweight

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Serum Clearance of Micafungin

  0-24 Hrs

Study Arms (2)

Subjects recieving 100 mg of Micafungin

ACTIVE COMPARATOR

Drug: Micafungin

Subjects recieving 300 mg of Micafungin

ACTIVE COMPARATOR

Drug: Micafungin

Interventions

Micafungin DRUG

100 mg IV infusion over 1 hour

Subjects recieving 100 mg of Micafungin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Obesity; Nutrition Disorders; Overweight; Body Weight; Signs and Symptoms; Mycoses; Overnutrition

Interventions

Micafungin

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Pathological Conditions, Signs and Symptoms; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Echinocandins; Peptides, Cyclic

Limitations and 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.

Results Point of Contact

• Title: Tawanda Gumbo
• Organization: Unknown

Unknown@utsouthwestern.edu

Study Officials

• Tawanda Gumbo, MD

  University of Texas, Southwestern Medical Center at Dallas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2010
• First Posted: March 19, 2010
• Study Start: November 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: June 1, 2010
• Last Updated: November 27, 2020
• Results First Posted: November 27, 2020

Record last verified: 2020-11

Locations

US (1)