Trial Outcomes & Findings for Staccato Prochlorperazine Single Dose PK Study (NCT NCT00610727)

NCT ID: NCT00610727

Last Updated: 2025-03-27

Results Overview

Time from dose to peak prochlorperazine concentration

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 54 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2025-03-27

Participant Flow

Participant milestones

Measure	Qualification & Crossover Arm, Inhaled Prochlorperazine vs IV Prochlorperazine 10 mg IV over 2 min qualification Prochlorperazine 0.5 mg IV over 5 sec crossover Inhaled prochlorperazine 0.625 mg ALL SUBJECTS RECEIVED ALL TREATMENT	Inhaled Prochlorperazine 1.25 mg Inhaled Staccato prochlorperazine 1.25 mg Inhaled prochlorperazine 1.25 mg: Inhaled Staccato Prochlorperazine 1.25 mg	Inhaled Prochlorperazine 2.5 mg Inhaled Staccato prochlorperazine 2.5 mg Inhaled prochlorperazine 2.5 mg: Inhaled Staccato Prochlorperazine 2.5 mg	Inhaled Prochlorperazine 5 mg Inhaled Staccato prochlorperazine 5 mg Inhaled prochlorperazine 5 mg: InhaledStaccato Prochlorperazine 5 mg	Inhaled Prochlorperazine 10 mg Inhaled Staccato prochlorperazine 10 mg Inhaled prochlorperazine 10 mg: InhaledStaccato Prochlorperazine 10 mg	Inhaled Placebo inhaled Staccato Placebo (0 mg) Inhaled placebo: Inhaled Staccato Placebo (0 mg)
Overall Study STARTED	14	8	8	8	8	8
Overall Study COMPLETED	14	8	8	8	8	8
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Staccato Prochlorperazine Single Dose PK Study

Baseline characteristics by cohort

Measure	Qualification & Crossover, Inhaled Prochlorperazine vs IV n=14 Participants Prochlorperazine 10 mg IV over 2 min qualification Prochlorperazine 0.5 mg IV over 5 sec crossover Inhaled prochlorperazine 0.625 mg ALL SUBJECTS RECEIVED ALL 3 TREATMENTS	Inhaled Prochlorperazine 1.25 mg n=8 Participants Inhaled Staccato prochlorperazine 1.25 mg Inhaled prochlorperazine 1.25 mg: Inhaled Staccato Prochlorperazine 1.25 mg	Inhaled Prochlorperazine 2.5 mg n=8 Participants Inhaled Staccato prochlorperazine 2.5 mg Inhaled prochlorperazine 2.5 mg: Inhaled Staccato Prochlorperazine 2.5 mg	Inhaled Prochlorperazine 5 mg n=8 Participants Inhaled Staccato prochlorperazine 5 mg Inhaled prochlorperazine 5 mg: InhaledStaccato Prochlorperazine 5 mg	Inhaled Prochlorperazine 10 mg n=8 Participants Inhaled Staccato prochlorperazine 10 mg Inhaled prochlorperazine 10 mg: InhaledStaccato Prochlorperazine 10 mg	Inhaled Placebo n=8 Participants inhaled Staccato Placebo (0 mg) Inhaled placebo: Inhaled Staccato Placebo (0 mg)	Total n=54 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	8 Participants n=4 Participants	8 Participants n=21 Participants	8 Participants n=10 Participants	54 Participants n=115 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Age, Continuous	29.4 years STANDARD_DEVIATION 7.86 • n=5 Participants	25.1 years STANDARD_DEVIATION 3.44 • n=7 Participants	25 years STANDARD_DEVIATION 4.57 • n=5 Participants	26.4 years STANDARD_DEVIATION 8.94 • n=4 Participants	28.8 years STANDARD_DEVIATION 10.2 • n=21 Participants	23.5 years STANDARD_DEVIATION 7.03 • n=10 Participants	25.8 years STANDARD_DEVIATION 7.09 • n=115 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	4 Participants n=10 Participants	26 Participants n=115 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	4 Participants n=10 Participants	28 Participants n=115 Participants
Region of Enrollment United States	14 participants n=5 Participants	8 participants n=7 Participants	8 participants n=5 Participants	8 participants n=4 Participants	8 participants n=21 Participants	8 participants n=10 Participants	54 participants n=115 Participants

PRIMARY outcome

Timeframe: 24 hours

Population: Pharmacokinetic Population

Time from dose to peak prochlorperazine concentration

Outcome measures

Measure	0.5 mg 5 Sec IV n=7 Participants 0.5 mg 5 sec IV prochlorperazine	0.625 mg Inhaled Prochlorperazine n=8 Participants 0.625 mg Inhaled prochlorperazine drug	1.25 mg Inhaled n=8 Participants 1.25 mg Inhaled Prochlorperazine	2.5 mg Inhaled n=8 Participants 2.5 mg Inhaled Prochlorperazine	5 mg Inhaled n=8 Participants 5 mg Inhaled Prochlorperazine	10 mg Inhaled n=8 Participants 10 mg Inhaled Prochlorperazine
Time to Peak (Tmax)	0.042 hours Interval 0.025 to 0.067	0.033 hours Interval 0.025 to 0.042	0.025 hours Interval 0.013 to 0.082	0.033 hours Interval 0.017 to 0.033	0.040 hours Interval 0.017 to 0.115	0.033 hours Interval 0.013 to 0.108

SECONDARY outcome

Timeframe: 24 hours

Population: Bioavailability crossover subjects, n=8

Absolute bioavailability of inhaled prochlorperazine via AUC infinity

Outcome measures

Measure	0.5 mg 5 Sec IV n=8 Participants 0.5 mg 5 sec IV prochlorperazine	0.625 mg Inhaled Prochlorperazine 0.625 mg Inhaled prochlorperazine drug	1.25 mg Inhaled 1.25 mg Inhaled Prochlorperazine	2.5 mg Inhaled 2.5 mg Inhaled Prochlorperazine	5 mg Inhaled 5 mg Inhaled Prochlorperazine	10 mg Inhaled 10 mg Inhaled Prochlorperazine
Absolute Bioavailability of Inhaled Prochlorperazine	0.98 Fraction absorbed Interval 0.73 to 1.34	—	—	—	—	—

SECONDARY outcome

Timeframe: 24 hours

Population: Pharmacokinetic Population, n=40

Dose proportionality by power analysis examines the linear regression of the log-AUC versus log-Dose on a by-patient basis across all doses administered. The slope and 90% confidence interval (CI) provide a clear, quantitative (best practices) assessment of the relationship of drug delivered to dose administered. The units on such analyses are generally those of slope (rise over run), with 1.000 being "perfect". Although any positive slope might be considered clinically useful, a 90% CI within the criteria of 0.800-1.250 may be considered a delivery system which is "as good as it gets".

Outcome measures

Measure	0.5 mg 5 Sec IV n=40 Participants 0.5 mg 5 sec IV prochlorperazine	0.625 mg Inhaled Prochlorperazine 0.625 mg Inhaled prochlorperazine drug	1.25 mg Inhaled 1.25 mg Inhaled Prochlorperazine	2.5 mg Inhaled 2.5 mg Inhaled Prochlorperazine	5 mg Inhaled 5 mg Inhaled Prochlorperazine	10 mg Inhaled 10 mg Inhaled Prochlorperazine
Dose Proportionality of Inhaled Prochlorperazine by Power Analysis	1.089 Slope of Power Regression Interval 0.99 to 1.2	—	—	—	—	—

Adverse Events

IV Prochlorperazine 10 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

IV Prochlorperazine 0.5 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Inhaled Prochlorperazine 0.625

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Inhaled Prochlorperazine 1.25 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Inhaled Prochlorperazine 2.5 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Inhaled Prochlorperazine 5 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Inhaled Prochlorperazine 10 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Inhaled Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	IV Prochlorperazine 10 mg n=14 participants at risk Intravenous prochlorperazine 10 mg	IV Prochlorperazine 0.5 mg n=8 participants at risk Intravenous prochlorperazine 0.5 mg	Inhaled Prochlorperazine 0.625 n=8 participants at risk Inhaled prochlorperazine 0.625 mg	Inhaled Prochlorperazine 1.25 mg n=8 participants at risk Inhaled Staccato prochlorperazine 1.25 mg	Inhaled Prochlorperazine 2.5 mg n=8 participants at risk Inhaled Staccato prochlorperazine 2.5 mg	Inhaled Prochlorperazine 5 mg n=8 participants at risk Inhaled Staccato prochlorperazine 5 mg	Inhaled Prochlorperazine 10 mg n=8 participants at risk Inhaled Staccato prochlorperazine 10 mg	Inhaled Placebo n=8 participants at risk inhaled Staccato Placebo (0 mg)
Gastrointestinal disorders Nausea	7.1% 1/14 • Number of events 1 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .
Eye disorders Vision blurred	0.00% 0/14 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	12.5% 1/8 • Number of events 1 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .
General disorders Chest pain	0.00% 0/14 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	12.5% 1/8 • Number of events 1 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	12.5% 1/8 • Number of events 1 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .
General disorders Sensation of pressure in face	0.00% 0/14 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	12.5% 1/8 • Number of events 1 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .
Nervous system disorders Dizziness	0.00% 0/14 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	25.0% 2/8 • Number of events 2 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .
Nervous system disorders Dysgeusia	0.00% 0/14 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	12.5% 1/8 • Number of events 1 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .
Nervous system disorders Headache	0.00% 0/14 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	12.5% 1/8 • Number of events 1 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .
Nervous system disorders Somnolence	21.4% 3/14 • Number of events 3 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .
Nervous system disorders Syncope vasovagal	7.1% 1/14 • Number of events 1 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .
Psychiatric disorders Anxiety	7.1% 1/14 • Number of events 1 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	12.5% 1/8 • Number of events 1 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/14 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	25.0% 2/8 • Number of events 2 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	12.5% 1/8 • Number of events 1 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	12.5% 1/8 • Number of events 1 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .	0.00% 0/8 • Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .

Additional Information

Dave Hasegawa, VP, Device Development

Alexza Pharmaceuticals, Inc.

Phone: 650.947.7031

Email: dhasegawa@alexza.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60