Safety and PK of Nikkomycin Z for Coccidioides Pneumonia Treatment

Brief Title

Safety and PK of Nikkomycin Z for Coccidioides Pneumonia Treatment

Official Title

Phase I/II Evaluation of the Safety, Pharmacokinetics, and Preliminary Effectiveness of Nikkomycin Z in the Treatment of Patients With Uncomplicated Coccidioides Pneumonia

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. Patients with mild forms of
      Valley Fever pneumonia will be eligible to participate and will be allocated to receive
      treatment with nikkomycin Z (various doses) or a placebo. A secondary goal of this study is
      to evaluate the effectiveness and dose response of nikkomycin Z in an exploratory analysis.
    

Detailed Description

      Every year there are 50,000 new U.S. cases of coccidioidomycosis (Valley Fever). The majority
      of these illnesses occur as a result of endemic exposure in Arizona and California. The
      benefits of antifungal therapy for uncomplicated disease are not currently established.
      Current therapies for serious and complicated forms of coccidioidomycosis are only partially
      effective and in themselves are unable to eradicate the fungus from sites of infection,
      commonly resulting in breakthrough infection and/or relapse. Nikkomycin Z is effective in the
      mouse model and results in improved microbiological response over fluconazole.

      The goals of this study include: 1) Evaluating the safety and tolerance of nikkomycin Z
      following administration of multiple doses (50 mg Q 12 h to 750 mg Q 8 h) for two week and 2)
      Evaluating the pharmacokinetics of nikkomycin Z after single and multiple doses in
      relationship to dose. The study will include patients with uncomplicated Coccidioides
      pneumonia (mild illness) which will allow exploratory analysis of efficacy and dose response
      based on biomarkers.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Evaluate the multiple dose pharmacokinetics of nikkomycin Z in patients with uncomplicated coccidioidal pneumonia

Condition

Coccidioidomycosis

Intervention

nikkomycin Z

Study Arms / Comparison Groups

 A
Description:  nikkomycin Z 50 mg BID versus placebo BID x 14 days

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

6

Start Date

September 2007

Completion Date

September 2009

Primary Completion Date

September 2009

Eligibility Criteria

        Inclusion Criteria:

          -  Age >= 18 years and <= 50 years

          -  Male or Female (if female, must have a negative pregnancy test and agree to use an
             acceptable contraception method)

          -  Able to understand study and give written informed consent

          -  Have a respiratory illness with at least one of the following: Cough, chest pain
             dyspnea or tachypnea, sputum production, or fever/chills/night sweats

          -  Have a new or suspected new pulmonary infiltrate on Chest X-ray

          -  Have a positive coccidioidal serology by EIA or immunodiffusion

        Exclusion Criteria:

          -  Patients under the age of 18 years or over 50 years

          -  Patients with a history of confirmed coccidioidal infection

          -  Laboratory diagnosis of another etiology for the inclusion-defining illness

          -  Inability to comprehend study and provide informed consent

          -  History of or current evidence of major organ disease

          -  Concomitant use of prednisone and other corticosteroids not permitted

          -  Concomitant immunosuppressive therapy is not permitted

          -  Concomitant antibacterial therapy is not permitted
      

Gender

All

Ages

18 Years - 50 Years

Accepts Healthy Volunteers

No

Contacts

David E Nix, Pharm D, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00614666

Organization ID

VCFE-2007-001


Responsible Party

Sponsor

Study Sponsor

University of Arizona

Collaborators

 FDA Office of Orphan Products Development

Study Sponsor

David E Nix, Pharm D, Principal Investigator, University of Arizona


Verification Date

August 2009