Study: NCT00614666

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: nikkomycin Z
Description: 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=8) vs placebo capsule BID (n=2)~* 250 mg BID (n=8) vs Placebo capsule BID (n=2)~* 500 mg BID (n=8) vs Placebo capsule BID (n=2)~* 750 mg TID (n=8) 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.~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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: nikkomycin Z
Description: 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=8) vs placebo capsule BID (n=2)~* 250 mg BID (n=8) vs Placebo capsule BID (n=2)~* 500 mg BID (n=8) vs Placebo capsule BID (n=2)~* 750 mg TID (n=8) 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.~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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: nikkomycin Z
Description: 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=8) vs placebo capsule BID (n=2)~* 250 mg BID (n=8) vs Placebo capsule BID (n=2)~* 500 mg BID (n=8) vs Placebo capsule BID (n=2)~* 750 mg TID (n=8) 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.~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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: nikkomycin Z
Description: 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=8) vs placebo capsule BID (n=2)~* 250 mg BID (n=8) vs Placebo capsule BID (n=2)~* 500 mg BID (n=8) vs Placebo capsule BID (n=2)~* 750 mg TID (n=8) 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.~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.