Trial Outcomes & Findings for A Study of M207 With Intranasal Zolmitriptan in Healthy Volunteers (NCT NCT03708744)
NCT ID: NCT03708744
Last Updated: 2020-01-18
Results Overview
maximum observed plasma concentration
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
pre-dose, 2, 5, 10, 15, 20, 30, 45, 60, 90 minutes, 2, 4, 8, 12, 24 hours post-dose
Results posted on
2020-01-18
Participant Flow
4-way crossover, each subject randomized to receive A, B, C, and D in one of four sequences. A: M207 3.8 mg, two 1.9 mg patches, 30 min, upper arm B: M207 3.8 mg, two 1.9 mg patches, 30 min, thigh C: M207 3.8 mg, two 1.9 mg patches, 1 hr, upper arm D: Intranasal zolmitriptan 2.5 mg One subject randomized to CADB was given ABCD.
Participant milestones
| Measure |
ABCD
A: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (upper arm application) B: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (thigh application) C: M207 3.8 mg administered as two 1.9 mg patches, 1 hour wear time (upper arm application) D: Intranasal zolmitriptan 2.5 mg
|
BDAC
B: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (thigh application) D: Intranasal zolmitriptan 2.5 mg A: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (upper arm application) C: M207 3.8 mg administered as two 1.9 mg patches, 1 hour wear time (upper arm application)
|
CADB
C: M207 3.8 mg administered as two 1.9 mg patches, 1 hour wear time (upper arm application) A: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (upper arm application) D: Intranasal zolmitriptan 2.5 mg B: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (thigh application)
|
DCBA
D: Intranasal zolmitriptan 2.5 mg C: M207 3.8 mg administered as two 1.9 mg patches, 1 hour wear time (upper arm application) B: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (thigh application) A: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (upper arm application)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
5
|
6
|
|
Overall Study
COMPLETED
|
7
|
6
|
4
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
ABCD
A: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (upper arm application) B: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (thigh application) C: M207 3.8 mg administered as two 1.9 mg patches, 1 hour wear time (upper arm application) D: Intranasal zolmitriptan 2.5 mg
|
BDAC
B: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (thigh application) D: Intranasal zolmitriptan 2.5 mg A: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (upper arm application) C: M207 3.8 mg administered as two 1.9 mg patches, 1 hour wear time (upper arm application)
|
CADB
C: M207 3.8 mg administered as two 1.9 mg patches, 1 hour wear time (upper arm application) A: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (upper arm application) D: Intranasal zolmitriptan 2.5 mg B: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (thigh application)
|
DCBA
D: Intranasal zolmitriptan 2.5 mg C: M207 3.8 mg administered as two 1.9 mg patches, 1 hour wear time (upper arm application) B: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (thigh application) A: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (upper arm application)
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of M207 With Intranasal Zolmitriptan in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=24 Participants
Each subject received each of the four treatments below in one of four treatment sequences.
A: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (upper arm application) B: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (thigh application) C: M207 3.8 mg administered as two 1.9 mg patches, 1 hour wear time (upper arm application) D: Intranasal zolmitriptan 2.5 mg
|
|---|---|
|
Age, Continuous
|
36.2 years
STANDARD_DEVIATION 9.44 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
|
BMI
|
26.93 kg/m^2
STANDARD_DEVIATION 3.264 • n=5 Participants
|
PRIMARY outcome
Timeframe: pre-dose, 2, 5, 10, 15, 20, 30, 45, 60, 90 minutes, 2, 4, 8, 12, 24 hours post-dosemaximum observed plasma concentration
Outcome measures
| Measure |
Treatment A
n=23 Participants
Treatment A: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (upper arm application)
A: M207 3.8mg, 30 min, upper arm: A: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (upper arm application)
|
Treatment B
n=22 Participants
Treatment B: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (thigh application)
B: M207 3.8 mg, 30 min, thigh: B: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (thigh application)
|
Treatment C
n=23 Participants
Treatment C: M207 3.8 mg administered as two 1.9 mg patches, 1 hour wear time (upper arm application)
C: M207 3.8 mg, 1 hr, upper arm: C: M207 3.8 mg administered as two 1.9 mg patches, 1 hour wear time (upper arm application)
|
Treatment D
n=23 Participants
Treatment D: Intranasal zolmitriptan 2.5 mg
D:zolmitriptan nasal spray: D: 2.5 mg/0.1 mL intranasal zolmitriptan
|
|---|---|---|---|---|
|
Cmax
|
9180.9 pg/mL
Standard Deviation 4066.1
|
5925.9 pg/mL
Standard Deviation 2353.3
|
15224.3 pg/mL
Standard Deviation 12972.9
|
3758.3 pg/mL
Standard Deviation 1711.6
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: Subjects who received treatment
number of subjects that experienced at least one adverse event
Outcome measures
| Measure |
Treatment A
n=23 Participants
Treatment A: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (upper arm application)
A: M207 3.8mg, 30 min, upper arm: A: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (upper arm application)
|
Treatment B
n=23 Participants
Treatment B: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (thigh application)
B: M207 3.8 mg, 30 min, thigh: B: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (thigh application)
|
Treatment C
n=24 Participants
Treatment C: M207 3.8 mg administered as two 1.9 mg patches, 1 hour wear time (upper arm application)
C: M207 3.8 mg, 1 hr, upper arm: C: M207 3.8 mg administered as two 1.9 mg patches, 1 hour wear time (upper arm application)
|
Treatment D
n=23 Participants
Treatment D: Intranasal zolmitriptan 2.5 mg
D:zolmitriptan nasal spray: D: 2.5 mg/0.1 mL intranasal zolmitriptan
|
|---|---|---|---|---|
|
Adverse Events
|
4 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: pre-dose, 2, 5, 10, 15, 20, 30, 45, 60, 90 minutes, 2, 4, 8, 12, 24 hours post-doseapparent half-life
Outcome measures
| Measure |
Treatment A
n=23 Participants
Treatment A: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (upper arm application)
A: M207 3.8mg, 30 min, upper arm: A: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (upper arm application)
|
Treatment B
n=21 Participants
Treatment B: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (thigh application)
B: M207 3.8 mg, 30 min, thigh: B: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (thigh application)
|
Treatment C
n=23 Participants
Treatment C: M207 3.8 mg administered as two 1.9 mg patches, 1 hour wear time (upper arm application)
C: M207 3.8 mg, 1 hr, upper arm: C: M207 3.8 mg administered as two 1.9 mg patches, 1 hour wear time (upper arm application)
|
Treatment D
n=19 Participants
Treatment D: Intranasal zolmitriptan 2.5 mg
D:zolmitriptan nasal spray: D: 2.5 mg/0.1 mL intranasal zolmitriptan
|
|---|---|---|---|---|
|
t(1/2)
|
2.692 hours
Standard Deviation 0.486
|
2.975 hours
Standard Deviation 1.217
|
2.959 hours
Standard Deviation 0.998
|
4.545 hours
Standard Deviation 1.535
|
Adverse Events
Treatment A
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Treatment B
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Treatment C
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Treatment D
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A
n=23 participants at risk
Treatment A: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (upper arm application)
A: M207 3.8mg, 30 min, upper arm: A: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (upper arm application)
|
Treatment B
n=23 participants at risk
Treatment B: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (thigh application)
B: M207 3.8 mg, 30 min, thigh: B: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (thigh application)
|
Treatment C
n=24 participants at risk
Treatment C: M207 3.8 mg administered as two 1.9 mg patches, 1 hour wear time (upper arm application)
C: M207 3.8 mg, 1 hr, upper arm: C: M207 3.8 mg administered as two 1.9 mg patches, 1 hour wear time (upper arm application)
|
Treatment D
n=23 participants at risk
Treatment D: Intranasal zolmitriptan 2.5 mg
D:zolmitriptan nasal spray: D: 2.5 mg/0.1 mL intranasal zolmitriptan
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/23 • 8 days
|
4.3%
1/23 • Number of events 1 • 8 days
|
0.00%
0/24 • 8 days
|
0.00%
0/23 • 8 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/23 • 8 days
|
4.3%
1/23 • Number of events 1 • 8 days
|
0.00%
0/24 • 8 days
|
0.00%
0/23 • 8 days
|
|
Gastrointestinal disorders
Dyspepsia
|
4.3%
1/23 • Number of events 1 • 8 days
|
0.00%
0/23 • 8 days
|
0.00%
0/24 • 8 days
|
0.00%
0/23 • 8 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/23 • 8 days
|
4.3%
1/23 • Number of events 1 • 8 days
|
4.2%
1/24 • Number of events 1 • 8 days
|
0.00%
0/23 • 8 days
|
|
Nervous system disorders
Headache
|
8.7%
2/23 • Number of events 2 • 8 days
|
0.00%
0/23 • 8 days
|
0.00%
0/24 • 8 days
|
0.00%
0/23 • 8 days
|
|
Nervous system disorders
Presyncope
|
0.00%
0/23 • 8 days
|
4.3%
1/23 • Number of events 1 • 8 days
|
0.00%
0/24 • 8 days
|
0.00%
0/23 • 8 days
|
|
Nervous system disorders
Somnolence
|
4.3%
1/23 • Number of events 1 • 8 days
|
0.00%
0/23 • 8 days
|
0.00%
0/24 • 8 days
|
0.00%
0/23 • 8 days
|
|
Respiratory, thoracic and mediastinal disorders
Intranasal hypoaesthesia
|
0.00%
0/23 • 8 days
|
4.3%
1/23 • Number of events 1 • 8 days
|
0.00%
0/24 • 8 days
|
0.00%
0/23 • 8 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/23 • 8 days
|
4.3%
1/23 • Number of events 1 • 8 days
|
0.00%
0/24 • 8 days
|
4.3%
1/23 • Number of events 1 • 8 days
|
Additional Information
Dr. Don Kellerman, Sr. VP, Clinical Development and Medical Affairs
Zosano Pharma Corporation
Phone: +1 (510) 745-4004
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60