NCT01877642

ADASUVE-Lorazepam Drug-Drug Interaction

ADASUVE®-Lorazepam Drug-Drug Interaction Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Alexza Pharmaceuticals, Inc. · Unknown
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study will compare the safety and effects over time for giving both ADASUVE and lorazepam (intramuscular) compared to that of each agent given alone.

Detailed description

The objective of this study is to compare the safety and pharmacodynamic profiles of concomitant administration of a single dose of ADASUVE and lorazepam (IM) compared to that of each agent administered alone. Respiratory pharmacodynamics will be monitored through recordings of respirations/minute and pulse oximetry. Other pharmacodynamic safety measures will include effects on blood pressure, heart rate, sedation and psychomotor measures of attention, information processing speed, reaction time, and coordination. Initially, 4 subjects will receive lorazepam 1 mg IM + ADASUVE 10 mg open label to validate the dose regimen. After the safety data are reviewed and the dose regimen confirmed, 18 non-obese, healthy male or female volunteers between the ages of 18 and 50 will be enrolled in this double-blinded, double-dummy, randomized, 3-period cross-over drug interaction study.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Lorazepam 1 mg IM	Lorazepam 1 mg intramuscular
DRUG	Inhaled loxapine 10 mg	Inhaled Staccato loxapine 10 mg
DRUG	Inhaled Placebo	Inhaler with no drug in it to mimic the ADASUVE inhaler
DRUG	Placebo IM	intramuscular placebo to mimic lorazepam 1 mg IM

Timeline

• Start date: 2013-06-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2013-06-14
• Last updated: 2017-12-13
• Results posted: 2017-12-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study