Trial Outcomes & Findings for Staccato Prochlorperazine Single Dose PK Study (NCT NCT00610727)
NCT ID: NCT00610727
Last Updated: 2026-04-22
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
2026-04-22
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=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=60 Participants
|
8 Participants
n=56 Participants
|
8 Participants
n=116 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=3 Participants
|
8 Participants
n=6 Participants
|
54 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
29.4 years
STANDARD_DEVIATION 7.86 • n=60 Participants
|
25.1 years
STANDARD_DEVIATION 3.44 • n=56 Participants
|
25 years
STANDARD_DEVIATION 4.57 • n=116 Participants
|
26.4 years
STANDARD_DEVIATION 8.94 • n=7 Participants
|
28.8 years
STANDARD_DEVIATION 10.2 • n=3 Participants
|
23.5 years
STANDARD_DEVIATION 7.03 • n=6 Participants
|
25.8 years
STANDARD_DEVIATION 7.09 • n=7 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=60 Participants
|
4 Participants
n=56 Participants
|
4 Participants
n=116 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
26 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=60 Participants
|
4 Participants
n=56 Participants
|
4 Participants
n=116 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
28 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=60 Participants
|
8 participants
n=56 Participants
|
8 participants
n=116 Participants
|
8 participants
n=7 Participants
|
8 participants
n=3 Participants
|
8 participants
n=6 Participants
|
54 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: 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 hoursPopulation: 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 hoursPopulation: 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 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
IV Prochlorperazine 10 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
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)
|
IV Prochlorperazine 10 mg
n=14 participants at risk
Intravenous prochlorperazine 10 mg
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
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 .
|
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 .
|
|
Eye disorders
Vision blurred
|
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 .
|
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 .
|
|
General disorders
Chest pain
|
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 .
|
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 .
|
|
General disorders
Sensation of pressure in face
|
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 .
|
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 .
|
|
Nervous system disorders
Dizziness
|
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 .
|
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 .
|
|
Nervous system disorders
Dysgeusia
|
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 .
|
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 .
|
|
Nervous system disorders
Headache
|
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 .
|
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 .
|
|
Nervous system disorders
Somnolence
|
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 .
|
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 .
|
|
Nervous system disorders
Syncope vasovagal
|
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 .
|
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 .
|
|
Psychiatric disorders
Anxiety
|
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 .
|
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 .
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
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 .
|
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 .
|
Additional Information
Dave Hasegawa, VP, Device Development
Alexza Pharmaceuticals, Inc.
Phone: 650.947.7031
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60