Comparison of Nikkomycin Z Bioavailability Under Fed and Fasting Conditions

NCT01647256 | Terminated Phase 1

• 1 other identifier: VFCE-2011-004
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Bioavailability; Fed; Fasting

Outcome Measures

Primary Outcomes (1)

• Rate and extent of Nikkomycin Z absorption under fed and fasting conditions

  24 hours

Secondary Outcomes (1)

• Extent of Nikkomycin Z urinary excretion

  24 hours

Study Arms (2)

Nikkomycin Z fed - fasting

EXPERIMENTAL

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

Nikkomycin Z fasting - fed

EXPERIMENTAL

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

Interventions

Nikkomycin Z DRUG

Capsule, 500 mg, single-dose

Nikkomycin Z fasting - fed; Nikkomycin Z fed - fasting

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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%

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona - Clinical and Translational Science Research Center

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Lecithin Cholesterol Acyltransferase Deficiency; Fasting

Interventions

nikkomycin

Condition Hierarchy (Ancestors)

Hypoalphalipoproteinemias; Hypolipoproteinemias; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Feeding Behavior; Behavior

Study Officials

• Kathryn R Matthias, PharmD

  University of Arizona

  PRINCIPAL INVESTIGATOR

• David E Nix, PharmD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2012
• First Posted: July 23, 2012
• Study Start: July 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: June 1, 2013
• Last Updated: September 17, 2013

Record last verified: 2013-09

Locations

US (1)