Trial Outcomes & Findings for A Four-way Crossover Study of 3 Formulations of M207 With Intranasal Zolmitriptan in Healthy Volunteers (NCT NCT03978403)
NCT ID: NCT03978403
Last Updated: 2021-11-18
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, and 24 hours post-dose
Results posted on
2021-11-18
Participant Flow
Participant milestones
| Measure |
ABDC
A: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "Sled" coater and packaged in foil pouches; B: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "MACAP" coater and packaged in foil cups; C: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "miniMac" coater and packaged in foil cups; D: Zolmitriptan nasal 2.5 mg/0.1 mL single dose
|
BCAD
A: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "Sled" coater and packaged in foil pouches; B: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "MACAP" coater and packaged in foil cups; C: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "miniMac" coater and packaged in foil cups; D: Zolmitriptan nasal 2.5 mg/0.1 mL single dose
|
CDBA
A: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "Sled" coater and packaged in foil pouches; B: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "MACAP" coater and packaged in foil cups; C: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "miniMac" coater and packaged in foil cups; D: Zolmitriptan nasal 2.5 mg/0.1 mL single dose
|
DACB
A: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "Sled" coater and packaged in foil pouches; B: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "MACAP" coater and packaged in foil cups; C: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "miniMac" coater and packaged in foil cups; D: Zolmitriptan nasal 2.5 mg/0.1 mL single dose
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Four-way Crossover Study of 3 Formulations of M207 With Intranasal Zolmitriptan in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
ABDC
n=6 Participants
A: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "Sled" coater and packaged in foil pouches; B: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "MACAP" coater and packaged in foil cups; C: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "miniMac" coater and packaged in foil cups; D: Zolmitriptan nasal 2.5 mg/0.1 mL single dose
|
BCAD
n=6 Participants
A: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "Sled" coater and packaged in foil pouches; B: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "MACAP" coater and packaged in foil cups; C: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "miniMac" coater and packaged in foil cups; D: Zolmitriptan nasal 2.5 mg/0.1 mL single dose
|
CDBA
n=6 Participants
A: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "Sled" coater and packaged in foil pouches; B: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "MACAP" coater and packaged in foil cups; C: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "miniMac" coater and packaged in foil cups; D: Zolmitriptan nasal 2.5 mg/0.1 mL single dose
|
DACB
n=6 Participants
A: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "Sled" coater and packaged in foil pouches; B: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "MACAP" coater and packaged in foil cups; C: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "miniMac" coater and packaged in foil cups; D: Zolmitriptan nasal 2.5 mg/0.1 mL single dose
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
|
Age, Continuous
|
37.7 years
STANDARD_DEVIATION 9.69 • n=5 Participants
|
42.2 years
STANDARD_DEVIATION 4.36 • n=7 Participants
|
35.3 years
STANDARD_DEVIATION 10.09 • n=5 Participants
|
39.5 years
STANDARD_DEVIATION 9.87 • n=4 Participants
|
38.7 years
STANDARD_DEVIATION 8.63 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
|
Race (NIH/OMB)
Asian
|
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
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
24 participants
n=21 Participants
|
|
Body Mass Index
|
27.153 kg/m2
STANDARD_DEVIATION 3.9165 • n=5 Participants
|
27.118 kg/m2
STANDARD_DEVIATION 3.1446 • n=7 Participants
|
26.523 kg/m2
STANDARD_DEVIATION 4.8929 • n=5 Participants
|
27.242 kg/m2
STANDARD_DEVIATION 2.6340 • n=4 Participants
|
27.009 kg/m2
STANDARD_DEVIATION 3.5044 • n=21 Participants
|
PRIMARY outcome
Timeframe: pre-dose, 2, 5, 10, 15, 20, 30, 45, 60, 90 minutes; 2, 4 , 8, 12, and 24 hours post-dosemaximum observed plasma concentration
Outcome measures
| Measure |
M207 3.8 mg (Sled)
n=24 Participants
A: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "Sled" coater and packaged in foil pouches
|
M207 3.8 mg (MACAP)
n=24 Participants
B: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "MACAP" coater and packaged in foil cups
|
M207 3.8 mg (MiniMac)
n=24 Participants
C: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "miniMac" coater and packaged in foil cups
|
Zolmitriptan 2.5 mg (Intranasal)
n=24 Participants
D: Zolmitriptan intranasal 2.5 mg/0.1 mL single dose
|
|---|---|---|---|---|
|
Cmax
|
11670 pg/mL
Standard Deviation 30.7
|
9861 pg/mL
Standard Deviation 93.6
|
11680 pg/mL
Standard Deviation 66.3
|
3705 pg/mL
Standard Deviation 43.0
|
PRIMARY outcome
Timeframe: 48 hoursPopulation: Subjects who received treatment
Subjects with treatment emergent adverse events
Outcome measures
| Measure |
M207 3.8 mg (Sled)
n=24 Participants
A: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "Sled" coater and packaged in foil pouches
|
M207 3.8 mg (MACAP)
n=24 Participants
B: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "MACAP" coater and packaged in foil cups
|
M207 3.8 mg (MiniMac)
n=24 Participants
C: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "miniMac" coater and packaged in foil cups
|
Zolmitriptan 2.5 mg (Intranasal)
n=24 Participants
D: Zolmitriptan intranasal 2.5 mg/0.1 mL single dose
|
|---|---|---|---|---|
|
Adverse Events
|
18 Participants
|
15 Participants
|
13 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: pre-dose, 2, 5, 10, 15, 20, 30, 45, 60, 90 minutes; 2, 4 , 8, 12, and 24 hours post-doseTime to maximum concentration
Outcome measures
| Measure |
M207 3.8 mg (Sled)
n=24 Participants
A: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "Sled" coater and packaged in foil pouches
|
M207 3.8 mg (MACAP)
n=24 Participants
B: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "MACAP" coater and packaged in foil cups
|
M207 3.8 mg (MiniMac)
n=24 Participants
C: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "miniMac" coater and packaged in foil cups
|
Zolmitriptan 2.5 mg (Intranasal)
n=24 Participants
D: Zolmitriptan intranasal 2.5 mg/0.1 mL single dose
|
|---|---|---|---|---|
|
Tmax
|
0.529 hour
Interval 0.34 to 0.76
|
0.577 hour
Interval 0.04 to 0.79
|
0.575 hour
Interval 0.33 to 0.77
|
2.000 hour
Interval 0.56 to 4.0
|
Adverse Events
M207 3.8 mg (Sled)
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
M207 3.8 mg (MACAP)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
M207 3.8 mg (MiniMac)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Zolmitriptan 2.5 mg (Intranasal)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
M207 3.8 mg (Sled)
n=24 participants at risk
A: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "Sled" coater and packaged in foil pouches
|
M207 3.8 mg (MACAP)
n=24 participants at risk
B: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "MACAP" coater and packaged in foil cups
|
M207 3.8 mg (MiniMac)
n=24 participants at risk
C: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "miniMac" coater and packaged in foil cups
|
Zolmitriptan 2.5 mg (Intranasal)
n=24 participants at risk
D: Zolmitriptan intranasal 2.5 mg/0.1 mL single dose
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
4.2%
1/24 • 8 days total, 48 hours per intervention
|
4.2%
1/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
4.2%
1/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
|
Eye disorders
Photophobia
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
4.2%
1/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
|
Gastrointestinal disorders
Abdominal ditension
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
8.3%
2/24 • 8 days total, 48 hours per intervention
|
4.2%
1/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
8.3%
2/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
|
Gastrointestinal disorders
Nausea
|
8.3%
2/24 • 8 days total, 48 hours per intervention
|
4.2%
1/24 • 8 days total, 48 hours per intervention
|
4.2%
1/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
|
Gastrointestinal disorders
Rectal tenesmus
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
4.2%
1/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
4.2%
1/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
|
General disorders
Application site discolouration
|
50.0%
12/24 • 8 days total, 48 hours per intervention
|
50.0%
12/24 • 8 days total, 48 hours per intervention
|
37.5%
9/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
|
General disorders
Application site pain
|
4.2%
1/24 • 8 days total, 48 hours per intervention
|
4.2%
1/24 • 8 days total, 48 hours per intervention
|
8.3%
2/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
|
General disorders
Feeling hot
|
4.2%
1/24 • 8 days total, 48 hours per intervention
|
4.2%
1/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
|
General disorders
Vessel puncture site pain
|
4.2%
1/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
|
General disorders
Vessel puncture site swelling
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
4.2%
1/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
4.2%
1/24 • 8 days total, 48 hours per intervention
|
|
Injury, poisoning and procedural complications
Contusion
|
4.2%
1/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
|
Investigations
Heart rate increased
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
4.2%
1/24 • 8 days total, 48 hours per intervention
|
|
Investigations
Weight decreased
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
4.2%
1/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
4.2%
1/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal sstiffness
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
4.2%
1/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.2%
1/24 • 8 days total, 48 hours per intervention
|
4.2%
1/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
4.2%
1/24 • 8 days total, 48 hours per intervention
|
|
Nervous system disorders
Dizziness
|
8.3%
2/24 • 8 days total, 48 hours per intervention
|
4.2%
1/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
|
Nervous system disorders
Head discomfort
|
4.2%
1/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
4.2%
1/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
|
Nervous system disorders
Headache
|
4.2%
1/24 • 8 days total, 48 hours per intervention
|
8.3%
2/24 • 8 days total, 48 hours per intervention
|
4.2%
1/24 • 8 days total, 48 hours per intervention
|
4.2%
1/24 • 8 days total, 48 hours per intervention
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
4.2%
1/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
|
Nervous system disorders
Paraesthesea
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
4.2%
1/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
|
Nervous system disorders
Somnolence
|
4.2%
1/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
4.2%
1/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
4.2%
1/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
|
Reproductive system and breast disorders
Polymenorrhoea
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
4.2%
1/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
4.2%
1/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
4.2%
1/24 • 8 days total, 48 hours per intervention
|
0.00%
0/24 • 8 days total, 48 hours per intervention
|
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