Alexza Reports Promising Data From Phase I Insomnia Trial
Posted on: Wednesday, 30 April 2008, 09:01 CDT
Alexza Pharmaceuticals has announced positive results from a Phase I clinical trial of AZ-007, an inhalation product candidate being developed for the treatment of insomnia patients.
The AZ-007 Phase I clinical trial enrolled 40 healthy volunteers at a single US clinical center. The purpose of this trial was to assess the safety, tolerability and pharmacokinetic parameters of a single dose of AZ-007. Using a double blind, randomized, dose-escalation trial design, four doses of AZ-007 (ranging from 0.5 to 4.0mg) were compared to placebo.
AZ-007 (Staccato zaleplon) delivered an IV-like pharmacokinetic profile with a median time to peak venous concentration (Tmax) of 1.6 minutes. Zaleplon exposure was dose proportional across the four doses studied, as calculated by power analysis. Pharmacodynamics, measured as sedation assessed on a 100mm visual-analog scale, showed onset of effect as early as two minutes after dosing with AZ-007.
There were no serious adverse events. These data indicate a rapid onset of effect, apparently directly related to the IV-like pharmacokinetics, and showed that AZ-007 was generally safe and well tolerated in this population of healthy volunteers.
Source: Datamonitor
Related Articles
- Cancer Therapy & Research Center at The University of Texas Health Science Center and Oncolytics Biotech(R) Inc. Announce Multi-Trial Clinical Research Collaboration
- Bostwick Wins Approval to Initiate Phase I/II Prostate Cancer Trial
- Map Reports Positive Results of Asthma Trial
- MAP Pharmaceuticals Reports Positive Results From Comparative Pharmacokinetic Trial for Its Pediatric Asthma Product Candidate
- Genta Completes Initial Clinical Dosing of G4544, a New Oral Drug for Bone Diseases
- Affymax(R) Reports Phase 2 Clinical Dose Ranging Results of Once-Per-Month Hematide(TM) for the Treatment of Anemia
- Ambit Biosciences Begins Dosing in Leukemia Trial
- ZIOPHARM Announces Interim Results in ZIO-101 Phase I Solid Tumor Cancer Trial; Clinical Activity in Several Cancers
- WorldHeart Expands RELIANT Trial Clinical Executive Committee
 |
 |
User Comments (0)
RSS Feeds