Safety and PK of Nikkomycin Z for Coccidioides Pneumonia Treatment

NCT00614666 | Terminated Phase 1 Results DMC

• 1 other identifier: VCFE-2007-001
• Study Type: interventional
• Target: 6
• 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. 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.

Conditions

Coccidioidomycosis

Keywords

coccidioidomycosis; Valley Fever; nikkomycin Z

Outcome Measures

Primary Outcomes (2)

• Concentration of Nikkomycin Z in the Blood Over Time (AUC)

  0, 0.25, 0.5, 0.75, 1.0, 1.5, 2 , 3, 4, 6, 8 and 12 h hours post-dose on Day 1 and Day 14

• Highest Concentration of Nikkomycin Z in the Blood (Cmax)

  0, 0.25, 0.5, 0.75, 1.0, 1.5, 2 , 3, 4, 6, 8 and 12 h hours post-dose on Day 1 and Day 14

Study Arms (5)

A - First dose level (n=5)

EXPERIMENTAL

nikkomycin Z 50 mg BID x 14 days

Drug: nikkomycin Z

B - Second Dose Level (n=10)

EXPERIMENTAL

nikkomycin Z nikkomycin Z 250 mg BID x 14 days

Drug: nikkomycin Z

C - Third Dose Level (n=10)

EXPERIMENTAL

nikkomycin Z 500 mg BID x 14 days

Drug: nikkomycin Z

D - Fourth Dose Level (n=5)

EXPERIMENTAL

nikkomycin Z 750 BID x 14 days

Drug: nikkomycin Z

Placebo

PLACEBO COMPARATOR

placebo BID x 14 days

Drug: Placebo

Interventions

nikkomycin Z DRUG

Stage I: Multiple rising doses. Doses packaged on a unit dose basis in 50 and 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. * 50 mg BID (n=4) vs placebo capsule BID (n=1) * 50 mg BID (n=4) vs 250 mg BID (n=4) vs Placebo capsule BID (n=2) * 250 mg BID (n=4) vs 500 mg BID (n=4) vs Placebo capsule BID (n=2) * 500 mg BID (n=4) vs Placebo capsule BID (n=1) At least 4 subjects complete lower dose before randomization includes next higher dose. Stage II will be a single dose level selected based on pharmacodynamics and safety from Stage I for 20 additional subjects using 4:1 randomization.

A - First dose level (n=5); B - Second Dose Level (n=10); C - Third Dose Level (n=10); D - Fourth Dose Level (n=5)

Placebo DRUG

Placebo comparator

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Patients under the age of 18 years or over 50 years
• Patients with a prior history of confirmed coccidioidal infection
• 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

Sponsors & Collaborators

• University of Arizona: lead
• FDA Office of Orphan Products Development: collaborator

Study Sites (1)

Clinical & Translational Research Center - University of Arizona

Tucson, Arizona, 85721, United States

Location

Related Links

• The Valley Fever Center for Excellence

MeSH Terms

Conditions

Coccidioidomycosis

Interventions

nikkomycin

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

• Title: Dr. John Galgiani
• Organization: University of Arizona

spherule@email.arizona.edu

(520) 626-4968

Study Officials

• David E Nix, Pharm D

  University of Arizona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: January 31, 2008
• First Posted: February 13, 2008
• Study Start: September 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: April 16, 2025
• Results First Posted: April 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Study was terminated due to poor enrollment. Study report was not generated beyond safety data.
• Access Criteria: Contact Valley fever Solutions - current license for development.

Locations

US (1)