Comparison of Nikkomycin Z Bioavailability Under Fed and Fasting Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01647256
Recruitment Status : Terminated (Insufficient # subjects available for 2nd group; evaluating alternate study site)
First Posted : July 23, 2012
Last Update Posted : September 17, 2013
Information provided by (Responsible Party):
University of Arizona

Brief Summary:
The primary purpose of this study is to evaluate if eating a high fat meal versus not eating any food affects how the study drug (Nikkomycin Z) is absorbed into the body. The second purpose is to gain further information about the safety of Nikkomycin Z in healthy adults.

Condition or disease Intervention/treatment Phase
Healthy Drug: Nikkomycin Z Phase 1

Detailed Description:
To compare the single-dose bioavailability of Nikkomycin Z 500 mg (two 250 mg capsules) under fed and fasting conditions.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Comparison of Nikkomycin Z Bioavailability After Single Dose Administration Under Fed (High Fat Meal) Compared to Fasting Conditions
Study Start Date : July 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Nikkomycin Z fed - fasting

Period 1:

  • Day 1: Nikkomycin Z 500 mg with high fat breakfast

Period 2:

  • Day 1: Nikkomycin Z 500 mg under fasted conditions
Drug: Nikkomycin Z
Capsule, 500 mg, single-dose
Experimental: Nikkomycin Z fasting - fed

Period 1:

  • Day 1: Nikkomycin Z 500 mg under fasted conditions

Period 2:

  • Day 1: Nikkomycin Z 500 mg with high fat breakfast
Drug: Nikkomycin Z
Capsule, 500 mg, single-dose

Primary Outcome Measures :
  1. Rate and extent of Nikkomycin Z absorption under fed and fasting conditions [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Extent of Nikkomycin Z urinary excretion [ Time Frame: 24 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Be at least 18 years of age and not over 40 years of age
  • Be male, or female (non childbearing potential or using adequate contraception)
  • Have a body mass index between 18 and 29 kg/m2
  • Able to understand the study and give written informed consent
  • Be determined healthy based on a medical and laboratory evaluation

Exclusion Criteria:

  • Patients under the age of 18 years or over 40 years of age
  • Current smoker or history of smoking within 3 months of participation
  • Inability to comprehend study and provide written informed consent
  • Inability to comply with the study requirements
  • History of or current evidence of major organ disease
  • Renal disease - serum creatinine > 1.5 mg/dL, significant hematuria or proteinuria, known structural abnormality or chronic kidney disease
  • Hepatic disease - active viral hepatitis, history of hepatitis B or hepatitis C, bilirubin > 2.0, ALT or AST above normal upper limit for laboratory, alcoholic liver disease, other chronic liver disease
  • CNS disease or cognitive dysfunction - any past history of epilepsy, CNS infections, stroke, CNS bleed, severe headaches, major psychiatric illness, or current mental status changes
  • Lung disease - history of severe asthma, COPD, pulmonary tuberculosis, or other major lung disease
  • Cardiac disease - history or current evidence of ischemic coronary artery disease, myocardial infarction, heart failure, or significant arrhythmia
  • Gastrointestinal disease - presence of inflammatory bowel disease, difficulty swallowing, or any gastrointestinal probably that would limit taking oral medications or that may compromise absorption of oral medications
  • Cancer - History of hematologic malignancy or solid tumor excluding basal cell carcinoma limited to the skin within the past 5 years
  • History of autoimmune or inflammatory disease such as rheumatoid arthritis and lupus
  • Immunocompromised state - solid organ transplant, cancer chemotherapy, stem cell transplant with graft versus host disease, immunosuppressive therapy, or HIV infection
  • Recent weight loss of greater than 10%
  • Any other history or evidence of disease that in the opinion of the physician would increase the risk for the subject for clinical trial participation
  • Regular use of prescription medications, over-the-counter medications, or dietary/herbal supplements within 14 days of day 1. Occasional use of acetaminophen or over-the-counter NSAID within the 14 day window may be allowed at the P.I. discretion
  • Subjects who received another investigational drug within 30 days of enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01647256

United States, Arizona
University of Arizona - Clinical and Translational Science Research Center
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
University of Arizona
Principal Investigator: Kathryn R Matthias, PharmD University of Arizona
Principal Investigator: David E Nix, PharmD University of Arizona

Responsible Party: University of Arizona Identifier: NCT01647256     History of Changes
Other Study ID Numbers: VFCE-2011-004
First Posted: July 23, 2012    Key Record Dates
Last Update Posted: September 17, 2013
Last Verified: September 2013

Keywords provided by University of Arizona:

Additional relevant MeSH terms:
Antifungal Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action