Staccato® Granisetron Single Dose PK
brief summary
This study was conducted in 2 parts in separate treatment groups of healthy volunteers. Part A of the study was double-blind, randomized, and placebo-controlled; Part B is open label. The primary objectives for each part were as follows: Part A: 1. To examine the tolerability and safety of single ascending doses up to 3 mg of AZ-010 (Staccato Granisetron) in healthy volunteers 2. To characterize the pharmacokinetics (PK) of single ascending doses up to 3 mg of AZ-010 in healthy volunteers Part B: 1\. To compare the PK and safety of a single dose of 1 mg of AZ-010 with that of 1 mg granisetron hydrochloride intravenous (IV) injection in healthy volunteers. The 2 parts to the study were performed sequentially.
detailed description
Part A assessed single ascending orally inhaled doses of AZ-010 in a double-blind, placebo controlled design. The planned AZ-010 doses to be studied were 0.5 mg, 1 mg, and 3 mg delivered from 1 device each.
There were 3 cohorts of at least 8 subjects each, with at least 2 males and 2 females in each cohort. Each subject received a single dose of AZ-010, or matching Staccato® placebo; 6 subjects received AZ-010 and 2 subjects received Staccato® placebo per cohort.
Upon completion of each cohort, a review of the in-clinic safety and tolerability data was performed by the Principal Investigator (PI), Medical Monitor, and an independent data safety monitoring board (DSMB) to determine if there were adequate safety and tolerability data to support escalation to the next dose up to 3 mg.
Safety was evaluated by the PI, Medical Monitor, and DSMB upon completion of Part A and prior to start of Part B. PK data were analyzed and assessed through blood samples obtained for Parts A and B.
Part B Approximately 12 healthy volunteers were enrolled in this 2-period, 2-treatment open-label crossover design study assessing the PK profiles of AZ-010 (1 mg) and IV granisetron (1 mg).
Eligible consenting subjects were randomized to 1 of 2 treatment sequences, with a total of 12 subjects (6 subjects in each sequence, with at least 2 males and 2 females in each sequence).
Treatment periods were separated by at least a 3-day washout between doses.
official title
A Two Part Study Investigating the Safety and pk of Single Ascending Doses of Staccato Granisetron (AZ-010) and Crossover Comparison of the Pharmacokinetics and Safety of AZ-010 and Intravenous Granisetron in Healthy Volunteers