Trial Outcomes & Findings for Staccato Loxapine Single Dose PK (NCT NCT00444028)
NCT ID: NCT00444028
Last Updated: 2018-11-20
Results Overview
Tmax = time from inhalation to to maximum observed loxapine concentration
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
50 participants
Primary outcome timeframe
predose, 0.5, 1, 2, 3, 5, 10, 30 and 45 min, 1, 2, 4, 6, 12, and 24 hours
Results posted on
2018-11-20
Participant Flow
Fifty subjects were recruited by and studied in the clinical researech unit (CRU). Study dates: 30 September 2005 through 22 November 2005
To obtain 50 enrolled subjects, screening procedures and inclusion/exclusion criteria were evaluated for 126 subjects during a variable screening period of up to 21 days. No enrolled participants were excluded from the trial.
Participant milestones
| Measure |
Placebo
Staccato placebo inhalation device(s)
|
Staccato Loxapine 0.625 mg
inhalation of loxapine from a single 0.625 mg device
|
Staccato Loxapine 1.25 mg
inhalation of loxapine from a two 0.625 mg devices
|
Staccato Loxapine 2.5 mg
inhalation of loxapine from a single 2.5 mg device
|
Staccato Loxapine 5 mg
inhalation of loxapine from a single 5 mg device
|
Staccato Loxapine 10 mg
inhalation of loxapine from a two 5 mg devices
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
7
|
8
|
6
|
7
|
8
|
|
Overall Study
COMPLETED
|
14
|
7
|
8
|
6
|
7
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Staccato Loxapine Single Dose PK
Baseline characteristics by cohort
| Measure |
Placebo
n=14 Participants
Staccato placebo inhalation device(s)
|
Staccato Loxapine 0.625 mg
n=7 Participants
inhalation of loxapine from a single 0.625 mg device
|
Staccato Loxapine 1.25 mg
n=8 Participants
inhalation of loxapine from a two 0.625 mg devices
|
Staccato Loxapine 2.5 mg
n=6 Participants
inhalation of loxapine from a single 2.5 mg device
|
Staccato Loxapine 5 mg
n=7 Participants
inhalation of loxapine from a single 5 mg device
|
Staccato Loxapine 10 mg
n=8 Participants
inhalation of loxapine from a two 5 mg devices
|
Total
n=50 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
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
50 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
|
37.8 years
STANDARD_DEVIATION 10.55 • n=5 Participants
|
33.4 years
STANDARD_DEVIATION 10.44 • n=7 Participants
|
28 years
STANDARD_DEVIATION 7.11 • n=5 Participants
|
28.2 years
STANDARD_DEVIATION 6.05 • n=4 Participants
|
30.1 years
STANDARD_DEVIATION 13.53 • n=21 Participants
|
27.4 years
STANDARD_DEVIATION 7.65 • n=10 Participants
|
31.7 years
STANDARD_DEVIATION 10.14 • n=115 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
27 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
23 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
50 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: predose, 0.5, 1, 2, 3, 5, 10, 30 and 45 min, 1, 2, 4, 6, 12, and 24 hoursPopulation: PK Population (N=36) All subjects exposed to inhaled loxapine who provided concentration data
Tmax = time from inhalation to to maximum observed loxapine concentration
Outcome measures
| Measure |
Staccato Loxapine 0.625 mg
n=7 Participants
inhalation of loxapine from a single 0.625 mg device
|
Staccato Loxapine 1.25 mg
n=8 Participants
inhalation of loxapine from a two 0.625 mg devices
|
Staccato Loxapine 2.5 mg
n=6 Participants
inhalation of loxapine from a single 2.5 mg device
|
Staccato Loxapine 5 mg
n=7 Participants
inhalation of loxapine from a single 5 mg device
|
Staccato Loxapine 10 mg
n=8 Participants
inhalation of loxapine from a two 5 mg devices
|
|---|---|---|---|---|---|
|
Tmax
|
12.6 minutes
Standard Deviation 21.3
|
2.15 minutes
Standard Deviation 1.31
|
2.87 minutes
Standard Deviation 3.62
|
2.13 minutes
Standard Deviation 0.687
|
5.25 minutes
Standard Deviation 10
|
PRIMARY outcome
Timeframe: predose, 0.5, 1, 2, 3, 5, 10, 30 and 45 min, 1, 2, 4, 6, 12, and 24 hoursPopulation: PK Population (N=36) All subjects exposed to inhaled loxapine who provided concentration data
Half-life of the terminal elimination phase of loxapine concentrations
Outcome measures
| Measure |
Staccato Loxapine 0.625 mg
n=7 Participants
inhalation of loxapine from a single 0.625 mg device
|
Staccato Loxapine 1.25 mg
n=8 Participants
inhalation of loxapine from a two 0.625 mg devices
|
Staccato Loxapine 2.5 mg
n=6 Participants
inhalation of loxapine from a single 2.5 mg device
|
Staccato Loxapine 5 mg
n=7 Participants
inhalation of loxapine from a single 5 mg device
|
Staccato Loxapine 10 mg
n=8 Participants
inhalation of loxapine from a two 5 mg devices
|
|---|---|---|---|---|---|
|
Half-life
|
5.2 hours
Standard Deviation 1.3
|
6.56 hours
Standard Deviation 1.44
|
6.92 hours
Standard Deviation 1.94
|
6.2 hours
Standard Deviation 1.14
|
6.14 hours
Standard Deviation 2.16
|
PRIMARY outcome
Timeframe: predose, 0.5, 1, 2, 3, 5, 10, 30 and 45 min, 1, 2, 4, 6, 12, and 24 hoursPopulation: PK Population (N=36) All subjects exposed to inhaled loxapine who provided concentration data
elimination rate constant
Outcome measures
| Measure |
Staccato Loxapine 0.625 mg
n=7 Participants
inhalation of loxapine from a single 0.625 mg device
|
Staccato Loxapine 1.25 mg
n=8 Participants
inhalation of loxapine from a two 0.625 mg devices
|
Staccato Loxapine 2.5 mg
n=6 Participants
inhalation of loxapine from a single 2.5 mg device
|
Staccato Loxapine 5 mg
n=7 Participants
inhalation of loxapine from a single 5 mg device
|
Staccato Loxapine 10 mg
n=8 Participants
inhalation of loxapine from a two 5 mg devices
|
|---|---|---|---|---|---|
|
ke
|
.143 /hour
Standard Error .047
|
.111 /hour
Standard Error .026
|
.108 /hour
Standard Error .033
|
.115 /hour
Standard Error .020
|
.122 /hour
Standard Error .032
|
PRIMARY outcome
Timeframe: predose, 0.5, 1, 2, 3, 5, 10, 30 and 45 min, 1, 2, 4, 6, 12, and 24 hoursPopulation: PK Population (N=36) All subjects exposed to inhaled loxapine who provided concentration data
clearance (CL/F) of lozxapine
Outcome measures
| Measure |
Staccato Loxapine 0.625 mg
n=7 Participants
inhalation of loxapine from a single 0.625 mg device
|
Staccato Loxapine 1.25 mg
n=8 Participants
inhalation of loxapine from a two 0.625 mg devices
|
Staccato Loxapine 2.5 mg
n=6 Participants
inhalation of loxapine from a single 2.5 mg device
|
Staccato Loxapine 5 mg
n=7 Participants
inhalation of loxapine from a single 5 mg device
|
Staccato Loxapine 10 mg
n=8 Participants
inhalation of loxapine from a two 5 mg devices
|
|---|---|---|---|---|---|
|
Clearance
|
56.2 L/hour
Standard Deviation 14.1
|
55.9 L/hour
Standard Deviation 13.7
|
61.1 L/hour
Standard Deviation 18.8
|
53.8 L/hour
Standard Deviation 9.74
|
78 L/hour
Standard Deviation 25.8
|
PRIMARY outcome
Timeframe: predose, 0.5, 1, 2, 3, 5, 10, 30 and 45 min, 1, 2, 4, 6, 12, and 24 hoursPopulation: PK Population (N=36) All subjects exposed to inhaled loxapine who provided concentration data
maximum concentration of loxapine observed
Outcome measures
| Measure |
Staccato Loxapine 0.625 mg
n=7 Participants
inhalation of loxapine from a single 0.625 mg device
|
Staccato Loxapine 1.25 mg
n=8 Participants
inhalation of loxapine from a two 0.625 mg devices
|
Staccato Loxapine 2.5 mg
n=6 Participants
inhalation of loxapine from a single 2.5 mg device
|
Staccato Loxapine 5 mg
n=7 Participants
inhalation of loxapine from a single 5 mg device
|
Staccato Loxapine 10 mg
n=8 Participants
inhalation of loxapine from a two 5 mg devices
|
|---|---|---|---|---|---|
|
Cmax
|
6.5 ng/mL
Standard Deviation 8.79
|
9.7 ng/mL
Standard Deviation 3.49
|
62.9 ng/mL
Standard Deviation 63
|
105 ng/mL
Standard Deviation 80.6
|
134 ng/mL
Standard Deviation 118.8
|
PRIMARY outcome
Timeframe: predose, 0.5, 1, 2, 3, 5, 10, 30 and 45 min, 1, 2, 4, 6, 12, and 24 hoursPopulation: PK Population (N=36) All subjects exposed to inhaled loxapine who provided concentration data
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 |
Staccato Loxapine 0.625 mg
n=7 Participants
inhalation of loxapine from a single 0.625 mg device
|
Staccato Loxapine 1.25 mg
n=8 Participants
inhalation of loxapine from a two 0.625 mg devices
|
Staccato Loxapine 2.5 mg
n=6 Participants
inhalation of loxapine from a single 2.5 mg device
|
Staccato Loxapine 5 mg
n=7 Participants
inhalation of loxapine from a single 5 mg device
|
Staccato Loxapine 10 mg
n=8 Participants
inhalation of loxapine from a two 5 mg devices
|
|---|---|---|---|---|---|
|
Dose Proportionality (AUCinf) by Power Analysis
|
11.9 hr*mcg/L
Standard Deviation 3.70
|
23.4 hr*mcg/L
Standard Deviation 4.87
|
44.6 hr*mcg/L
Standard Deviation 14.7
|
95.5 hr*mcg/L
Standard Deviation 16.6
|
140.6 hr*mcg/L
Standard Deviation 44.6
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Staccato Loxapine 0.625 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Staccato Loxapine 1.25 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Staccato Loxapine 2.5 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Staccato Loxapine 5 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Staccato Loxapine 10 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=14 participants at risk
Staccato placebo inhalation device(s)
|
Staccato Loxapine 0.625 mg
n=7 participants at risk
inhalation of loxapine from a single 0.625 mg device
|
Staccato Loxapine 1.25 mg
n=8 participants at risk
inhalation of loxapine from a two 0.625 mg devices
|
Staccato Loxapine 2.5 mg
n=6 participants at risk
inhalation of loxapine from a single 2.5 mg device
|
Staccato Loxapine 5 mg
n=7 participants at risk
inhalation of loxapine from a single 5 mg device
|
Staccato Loxapine 10 mg
n=8 participants at risk
inhalation of loxapine from a two 5 mg devices
|
|---|---|---|---|---|---|---|
|
Gastrointestinal 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
14.3%
1/7 • 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
25.0%
2/8 • 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
33.3%
2/6 • 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
28.6%
2/7 • 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
75.0%
6/8 • 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
|
Gastrointestinal disorders
Nausea
|
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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
14.3%
1/7 • 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
12.5%
1/8 • 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
50.0%
3/6 • 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
14.3%
1/7 • 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
12.5%
1/8 • 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
|
General disorders
Fatigue
|
7.1%
1/14 • 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
0.00%
0/7 • 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
12.5%
1/8 • 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
16.7%
1/6 • 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
42.9%
3/7 • 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
37.5%
3/8 • 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
|
General disorders
Pallor
|
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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
0.00%
0/7 • 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
0.00%
0/6 • 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
0.00%
0/7 • 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
37.5%
3/8 • 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
|
Nervous system disorders
Disturbance in Attention
|
7.1%
1/14 • 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
14.3%
1/7 • 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
12.5%
1/8 • 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
0.00%
0/6 • 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
0.00%
0/7 • 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
|
Nervous system disorders
Dizziness
|
35.7%
5/14 • 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
28.6%
2/7 • 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
25.0%
2/8 • 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
50.0%
3/6 • 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
57.1%
4/7 • 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
75.0%
6/8 • 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
|
Nervous system disorders
Headache
|
14.3%
2/14 • 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
0.00%
0/7 • 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
25.0%
2/8 • 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
0.00%
0/6 • 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
14.3%
1/7 • 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
|
Nervous system disorders
Somnolence
|
21.4%
3/14 • 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
14.3%
1/7 • 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
25.0%
2/8 • 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
0.00%
0/6 • 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
28.6%
2/7 • 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
75.0%
6/8 • 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 at 17 pre-specified time points for the 24-hour period after dosing, as well as whenever spontaneously reported by the subjects or study staff
|
Additional Information
Executive VP, Research & Development, Regulatory & Quality
Alexza Pharmaceuticals, Inc
Phone: 650.944.7071
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60