Staccato® Granisetron Single Dose PK

• Status: Completed
• Trial end date: 2020-01-19
• Target enrollment: 0
• Participant gender: All

Summary

Part A: Single Ascending Dose in Healthy Volunteers This study will assess single ascending oral doses of AZ-010 in a placebo-controlled, double-blind design. The planned AZ-010 doses to be studied are 0.5 mg, 1 mg, and 3 mg.

Part B: Single Dose Crossover in Healthy Volunteers 2-period, 2-treatment open-label crossover design study assessing the pharmacokinetic profiles of AZ-010 (1 mg) and granisetron for IV injection (1 mg).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alexza Pharmaceuticals, Inc.
• Collaborator: Celerion
• Treatments: Granisetron

Criteria

Inclusion Criteria:

• Healthy based on a medical evaluation including history, physical examination, vital signs, electrocardiograms (ECGs) and laboratory tests assessed at the screening visit and prior to the first dose of study drug.

• Body weight ≥ 50 kg and BMI within the range of 18 to 32 kg/m2, inclusive, at screening.

• Negative urine tests for selected drugs of abuse and alcohol breath test at screening and Day 1.

Exclusion Criteria:

• Any significant medical condition