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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.
This protocol will serve as a Phase I, randomized, double-blind, placebo controlled, multiple-dose study to evaluate the safety, tolerance and pharmacokinetics of nikkomycin Z. Nikkomycin Z has previously been studied in a single dose protocol in healthy male subjects. This study is designed to run in parallel to protocol VFCE-2007-001 to provide additional data on safety and pharmacokinetics. The study will involve a total of 32 subjects (6 active/2 placebo per group) with a multiple, rising dose strategy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | nikkomycin Z 250 mg BID versus placebo BID x 14 days |
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| B | Experimental | nikkomycin Z 500 mg BID versus placebo BID x 14 days |
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| C | Experimental | nikkomycin Z 750 mg BID versus placebo BID x 14 days |
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| D | Experimental | nikkomycin Z 750 mg TID versus placebo TID x 14 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Determine safety and tolerance of nikkomycin Z in healthy subjects following administration of multiple doses. | four weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the multiple dose pharmacokinetics of nikkomycin Z in healthy subjects | two weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David E Nix, Pharm D | University of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical & Translational Research Center - University of Arizona | Tucson | Arizona | 85721 | United States |
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| ID | Term |
|---|---|
| C011952 | nikkomycin |
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