CoccidioidomycosisPhase 1/2NCT00614666
Safety and PK of Nikkomycin Z for Coccidioides Pneumonia Treatment
A Phase 1/2 study testing nikkomycin Z in people with Coccidioidomycosis, run by University of Arizona at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Coccidioidomycosis
- What is being tested?
- nikkomycin Z
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Sep 2009
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Patients under the age of 18 years or over 50 years
- Patients with a prior 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical & Translational Research Center - University of Arizona
Tucson, Arizona, 85721
About this study
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
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.
Read the 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.
- Conditions
- Coccidioidomycosis
- Being tested
- nikkomycin Z, Placebo
- Keywords
- coccidioidomycosis, Valley Fever, nikkomycin Z
- Medical subject headings
- Coccidioidomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nikkomycin ZDrug
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.
PlaceboDrug
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| A - First dose level (n=5) | Experimental | nikkomycin Z 50 mg BID x 14 days Receives: Drug: nikkomycin Z |
| B - Second Dose Level (n=10) | Experimental | nikkomycin Z nikkomycin Z 250 mg BID x 14 days Receives: Drug: nikkomycin Z |
| C - Third Dose Level (n=10) | Experimental | nikkomycin Z 500 mg BID x 14 days Receives: Drug: nikkomycin Z |
| D - Fourth Dose Level (n=5) | Experimental | nikkomycin Z 750 BID x 14 days Receives: Drug: nikkomycin Z |
| Placebo | Placebo comparator | placebo BID x 14 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Nikkomycin Z in the Blood Over Time (AUC)
Measured: 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)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startSep 2007
- Primary completionSep 2009
- Study completionSep 2009
Why it stopped: Recruitment challenges and lack of funding caused an early end to this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CoccidioidomycosisStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- FDA Office of Orphan Products Development
- Responsible party
- Sponsor
- Investigators
- David E Nix, Pharm D, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00614666
- Sponsor's protocol ID
- VCFE-2007-001
- Status last verified
- Jan 2025
- First submitted
- 31 Jan 2008
- Last updated
- 16 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: De-identified data may be shared for legitimate use to further nikkomycin Z development.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00614666
- Acronym / sponsor ID
- VCFE-2007-001
- Conditions
- Coccidioidomycosis
- Keywords
- coccidioidomycosis, Valley Fever, nikkomycin Z
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment challenges and lack of funding caused an early end to this study
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- FDA Office of Orphan Products Development
- Study start
- Sep 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 13 Feb 2008 (estimated)
- Results
- Posted 16 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| A - First dose level (n=5) | Experimental | Drug: nikkomycin Znikkomycin Z 50 mg BID x 14 days |
| B - Second Dose Level (n=10) | Experimental | Drug: nikkomycin Znikkomycin Z nikkomycin Z 250 mg BID x 14 days |
| C - Third Dose Level (n=10) | Experimental | Drug: nikkomycin Znikkomycin Z 500 mg BID x 14 days |
| D - Fourth Dose Level (n=5) | Experimental | Drug: nikkomycin Znikkomycin Z 750 BID x 14 days |
| Placebo | Placebo comparator | Drug: Placeboplacebo BID x 14 days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- Patients under the age of 18 years or over 50 years
- Patients with a prior 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nikkomycin ZStage 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. | Drug | A - First dose level (n=5), B - Second Dose Level (n=10), C - Third Dose Level (n=10), D - Fourth Dose Level (n=5) |
| PlaceboPlacebo comparator | Drug | Placebo |
Primary outcome
Concentration of Nikkomycin Z in the Blood Over Time (AUC)
Time frame: 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)
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The Valley Fever Center for ExcellenceLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified data may be shared for legitimate use to further nikkomycin Z development.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David E Nix, Pharm D principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing nikkomycin Z in people with Coccidioidomycosis, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of Nikkomycin Z in the Blood Over Time (AUC) (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.