Safety and PK of Nikkomycin Z in Healthy Subjects

NCT00834184 | Completed Phase 1 DMC

• 1 other identifier: VFCE-2008-002
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if nikkomycin Z is safe when administered at different dose levels for 14 days. The study will also determine blood levels and urinary excretion of nikkomycin Z in relation to dose administered. Healthy patients will be eligible to participate and will be allocated to receive nikkomycin Z (various doses) or a placebo.

Conditions

Healthy

Keywords

nikkomycin Z; pharmacokinetics; toxicity

Outcome Measures

Primary Outcomes (1)

• Determine safety and tolerance of nikkomycin Z in healthy subjects following administration of multiple doses.

  four weeks

Secondary Outcomes (1)

• Evaluate the multiple dose pharmacokinetics of nikkomycin Z in healthy subjects

  two weeks

Study Arms (4)

A

EXPERIMENTAL

nikkomycin Z 250 mg BID versus placebo BID x 14 days

Drug: nikkomycin Z

B

EXPERIMENTAL

nikkomycin Z 500 mg BID versus placebo BID x 14 days

Drug: nikkomycin Z

C

EXPERIMENTAL

nikkomycin Z 750 mg BID versus placebo BID x 14 days

Drug: nikkomycin Z

D

EXPERIMENTAL

nikkomycin Z 750 mg TID versus placebo TID x 14 days

Drug: nikkomycin Z

Interventions

nikkomycin Z DRUG

Multiple rising doses. Doses packaged on a unit dose basis in 250 mg capsules. Subjects take 1-3 capsules per dosing block for 14 days unless ADE or study withdrawal. Dose escalation unless a dose-limiting adverse effect is noted. Subjects assigned to BID dosing will receive 28 doses and subjects assigned to TID dosing will receive 42 doses. 250 mg BID (n=6) vs Placebo capsule BID (n=2), 500 mg BID (n=6) vs Placebo capsule BID (n=2), 750 mg BID (n=6) vs Placebo capsule BID (n=2), 750 mg TID (n=6) vs Placebo capsule TID (n=2) At least 4 subjects complete lower dose before randomization includes next higher dose, thus there are 4 arms for active intervention and corresponding placebos.

A; B; C; D

Eligibility Criteria

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

You may qualify if:

• Age \>= 18 years and \<= 40 years
• Male or Female (if female, must have a negative pregnancy test and agrees to use an acceptable contraception method)
• Able to understand 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
• 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 including:
• 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, significant arrhythmia
• Gastrointestinal disease - presence of inflammatory bowel disease, difficulty swallowing, or any gastrointestinal problem 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
• 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
• Immunocompromised state - solid organ transplant, cancer chemotherapy, BMT 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)

Clinical & Translational Research Center - University of Arizona

Tucson, Arizona, 85721, United States

Location

MeSH Terms

Interventions

nikkomycin

Study Officials

• David E Nix, Pharm D

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2009
• First Posted: February 3, 2009
• Study Start: October 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: November 23, 2020

Record last verified: 2020-11

Locations

US (1)