Comparison of Nikkomycin Z Bioavailability Under Fed and Fasting Conditions

Comparison of Nikkomycin Z Bioavailability After Single Dose Administration Under Fed (High Fat Meal) Compared to Fasting Conditions

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.

Study Overview

• Status: Terminated
• Conditions: Healthy
• Intervention / Treatment: Drug: Nikkomycin Z

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
• Enrollment (Actual): 5
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • University of Arizona - Clinical and Translational Science Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate and extent of Nikkomycin Z absorption under fed and fasting conditions	24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Extent of Nikkomycin Z urinary excretion	24 hours

Collaborators and Investigators

• Sponsor: University of Arizona
• Investigators: Principal Investigator: Kathryn R Matthias, PharmD, University of Arizona; Principal Investigator: David E Nix, PharmD, University of Arizona

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: July 16, 2012
• First Submitted That Met QC Criteria: July 18, 2012
• First Posted (Estimate): July 23, 2012

Study Record Updates

• Last Update Posted (Estimate): September 17, 2013
• Last Update Submitted That Met QC Criteria: September 16, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Bioavailability; Fasting; Fed
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antifungal Agents; Nikkomycin
• Other Study ID Numbers: VFCE-2011-004