Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00444028
Status:
COMPLETED
Last Update Posted:
2018-11-20
First Post:
2007-03-05
Brief Title:
Staccato Loxapine Single Dose PK
Sponsor:
Alexza Pharmaceuticals Inc
Organization:
Alexza Pharmaceuticals Inc
Study Overview
Official Title:
Safety Tolerability and Pharmacokinetics of a Single Dose of Staccato Loxapine for Inhalation in Normal Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study was to assess the safety tolerability and pharmacokinetics of a single inhaled dose of administered in 1 or 2 puffs Staccato Loxapine in healthy volunteers
Detailed Description:
Safety and pharmacokinetic data obtained from 50 subjects between the ages of 18 to 55 years entered into this randomized placebo-controlled study To obtain 50 enrolled subjects screening procedures and inclusionexclusion criteria were evaluated for 126 subjects during a variable screening period of up to 21 days Once enrolled subjects were randomized to either Staccato Loxapine or Staccato placebo
Plasma samples for pharmacokinetic analysis were collected beginning on Day 0 pre-dose and continuing for 24 hr post dose Blood samples for the PK analysis of loxapine and its metabolites 8-OH loxapine 7-OH loxapine and amoxapine were obtained at time 0 immediately before dosing at 30 sec 1 2 3 5 10 30 45 min 1 2 4 6 12 24 hr after dosing Plasma concentrations of loxapine and metabolites were used to estimate the following PK parameters for loxapine and its metabolites area under the plasma concentration time curve from time 0 extrapolated to infinity AUCinf AUC from time 0 to time tlast the last quantifiable concentration AUClast maximum observed plasma concentration Cmax observed time of Cmax tmax terminal phase elimination rate constant ke apparent terminal elimination half life calculated from ke T½ apparent total body clearance fraction absorbed calculated from AUCinf and dose CLF for loxapine and the metabolites where permitted by measurable concentrations
Safety was evaluated by the incidence of adverse events clinical laboratory testing blood chemistry hematology and urinalysis physical examination vital signs pulse oximetry postural vital signs 12-lead electrocardiogram pulmonary function tests continuous 12-lead Holter monitoring sedation assessments akathisia assessments
Plasma samples for pharmacokinetic analysis were collected beginning on Day 0 pre-dose and continuing for 24 hr post dose Blood samples for the PK analysis of loxapine and its metabolites 8-OH loxapine 7-OH loxapine and amoxapine were obtained at time 0 immediately before dosing at 30 sec 1 2 3 5 10 30 45 min 1 2 4 6 12 24 hr after dosing Plasma concentrations of loxapine and metabolites were used to estimate the following PK parameters for loxapine and its metabolites area under the plasma concentration time curve from time 0 extrapolated to infinity AUCinf AUC from time 0 to time tlast the last quantifiable concentration AUClast maximum observed plasma concentration Cmax observed time of Cmax tmax terminal phase elimination rate constant ke apparent terminal elimination half life calculated from ke T½ apparent total body clearance fraction absorbed calculated from AUCinf and dose CLF for loxapine and the metabolites where permitted by measurable concentrations
Safety was evaluated by the incidence of adverse events clinical laboratory testing blood chemistry hematology and urinalysis physical examination vital signs pulse oximetry postural vital signs 12-lead electrocardiogram pulmonary function tests continuous 12-lead Holter monitoring sedation assessments akathisia assessments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None