Trial · NCT00614666
Safety and PK of Nikkomycin Z for Coccidioides Pneumonia Treatment
NCT00614666, Phase 1, Phase 2, Terminated, University of Arizona; results first posted 2025-04-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and PK of Nikkomycin Z for Coccidioides Pneumonia Treatment. Trials, record NCT00614666. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00614666
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and PK of Nikkomycin Z for Coccidioides Pneumonia Treatment
- NCT number
- NCT00614666
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 6 participants, actual
- Lead sponsor
- University of Arizona
- Conditions
- Coccidioidomycosis
- Interventions
- nikkomycin Z, Placebo
- First posted
- 2008-02-13
- Last updated
- 2025-04-16
- Results first posted
- 2025-04-16
- Limitations and caveats
- Early termination leading to small numbers of subjects analyzed
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | |
| Primary | 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 |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | The study was terminated after enrollment of 6 subjects | mg*hr/L | MEAN |
| PRIMARY | 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 | The study was terminated after enrollment of 6 subjects | mg/L | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Concentration of Nikkomycin Z in the Blood Over Time (AUC) | A - First Dose Level (n=5) | Day 1 | 3.444 | Standard Deviation 0.710 | mg*hr/L |
| Concentration of Nikkomycin Z in the Blood Over Time (AUC) | B - Second Dose Level (n=10) | Day 1 | 19.923 | Standard Deviation NA | mg*hr/L |
| Concentration of Nikkomycin Z in the Blood Over Time (AUC) | A - First Dose Level (n=5) | Day 14 | 3.900 | Standard Deviation 1.583 | mg*hr/L |
| Concentration of Nikkomycin Z in the Blood Over Time (AUC) | B - Second Dose Level (n=10) | Day 14 | 24.045 | Standard Deviation NA | mg*hr/L |
| Highest Concentration of Nikkomycin Z in the Blood (Cmax) | A - First Dose Level (n=5) | Day 1 | 0.710 | Standard Deviation 0.188 | mg/L |
| Highest Concentration of Nikkomycin Z in the Blood (Cmax) | B - Second Dose Level (n=10) | Day 1 | 3.748 | Standard Deviation NA | mg/L |
| Highest Concentration of Nikkomycin Z in the Blood (Cmax) | A - First Dose Level (n=5) | Day 14 | 0.811 | Standard Deviation 0.248 | mg/L |
| Highest Concentration of Nikkomycin Z in the Blood (Cmax) | B - Second Dose Level (n=10) | Day 14 | 4.275 | Standard Deviation NA | mg/L |
Source ClinicalTrials.gov
Participant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | A - First Dose Level | 4 | |
| Overall Study | STARTED | B - Second Dose Level | 1 | |
| Overall Study | STARTED | C - Third Dose Level | 0 | |
| Overall Study | STARTED | D - Fourth Dose Level | 0 | |
| Overall Study | STARTED | Placebo | 1 | |
| Overall Study | COMPLETED | A - First Dose Level | 4 | |
| Overall Study | COMPLETED | B - Second Dose Level | 1 | |
| Overall Study | COMPLETED | C - Third Dose Level | 0 | |
| Overall Study | COMPLETED | D - Fourth Dose Level | 0 | |
| Overall Study | COMPLETED | Placebo | 1 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events50
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypotension | Vascular disorders | A - First Dose Level (n=5) | 1 | 4 | 1 |
| other | Hypotension | Vascular disorders | B - Second Dose Level (n=10) | 0 | 1 | |
| other | Hypotension | Vascular disorders | C - Third Dose Level (n=10) | 0 | 0 | |
| other | Hypotension | Vascular disorders | D - Fourth Dose Level (n=5) | 0 | 0 | |
| other | Hypotension | Vascular disorders | Placebo | 0 | 1 | |
| other | Near syncope | General disorders | A - First Dose Level (n=5) | 1 | 4 | 1 |
| other | Near syncope | General disorders | B - Second Dose Level (n=10) | 0 | 1 | |
| other | Near syncope | General disorders | C - Third Dose Level (n=10) | 0 | 0 | |
| other | Near syncope | General disorders | D - Fourth Dose Level (n=5) | 0 | 0 | |
| other | Near syncope | General disorders | Placebo | 0 | 1 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | A - First Dose Level (n=5) | 0 | 4 |
| Total, all-cause mortality | B - Second Dose Level (n=10) | 0 | 1 |
| Total, all-cause mortality | C - Third Dose Level (n=10) | 0 | 0 |
| Total, all-cause mortality | D - Fourth Dose Level (n=5) | 0 | 0 |
| Total, all-cause mortality | Placebo | 0 | 1 |
| Total, other adverse events | A - First Dose Level (n=5) | 3 | 4 |
| Total, other adverse events | B - Second Dose Level (n=10) | 1 | 1 |
| Total, other adverse events | C - Third Dose Level (n=10) | 0 | 0 |
| Total, other adverse events | D - Fourth Dose Level (n=5) | 0 | 0 |
| Total, other adverse events | Placebo | 1 | 1 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00614666
GET https://conductscience.org/api/trials/v1/NCT00614666/events?page=2