Trial Outcomes & Findings for A Study to Compare Zavegepant Concentration Using Samples Collected From the Vein Versus Patient-Centric Microsampling (NCT NCT05948085)
NCT ID: NCT05948085
Last Updated: 2026-01-29
Results Overview
Tasso device used was Tasso-Plus (for liquid blood sample collection). In Period 1, for the treated participants PK samples were collected using Tasso-Plus and simultaneously standard venous phlebotomy. Data was to be reported for Tasso-Plus vs. venous phlebotomy concentrations (same participants).
COMPLETED
PHASE1
14 participants
Tasso: 0.5, 1, 2, 4, 8 and 12 hours post dose on Day 1 of Period 1; Venous: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post dose on Day 1 of Period 1
2026-01-29
Participant Flow
A total of 14 participants were enrolled in this study.
Participant milestones
| Measure |
Zavegepant
On Day 1 of Period 1, all participants received Zavegepant 10 milligrams (mg) via intranasal (IN) route (single use unidose nasal spray). Period 1 was followed by Period 2. On Day 1 of Period 2, all participants received a butterscotch candy and 5 minutes later received Zavegepant 10 mg single use unidose nasal spray. Participants were followed up 28-35 days after the second (last) dose.
|
|---|---|
|
Treatment Period 1 (2 Days)
STARTED
|
14
|
|
Treatment Period 1 (2 Days)
COMPLETED
|
14
|
|
Treatment Period 1 (2 Days)
NOT COMPLETED
|
0
|
|
Treatment Period 2 (2 Days)
STARTED
|
14
|
|
Treatment Period 2 (2 Days)
COMPLETED
|
14
|
|
Treatment Period 2 (2 Days)
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Compare Zavegepant Concentration Using Samples Collected From the Vein Versus Patient-Centric Microsampling
Baseline characteristics by cohort
| Measure |
Zavegepant
n=14 Participants
On Day 1 of Period 1, all participants received Zavegepant 10 mg via IN route (single use unidose nasal spray). Period 1 was followed by Period 2. On Day 1 of Period 2, all participants received a butterscotch candy and 5 minutes later received Zavegepant 10 mg single use unidose nasal spray. Participants were followed up 28-35 days after the second (last) dose.
|
|---|---|
|
Age, Continuous
|
47.9 Years
STANDARD_DEVIATION 14.26 • n=35 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 30 minutes post-dose on Day 1 of Period 1Population: PK concentration analysis set: all enrolled participants who received 1 single IN dose of Zavegepant and provided at least 1 evaluable plasma concentration. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
Tasso device used was Tasso-Plus (for liquid blood sample collection). In Period 1, for the treated participants pharmacokinetic (PK) samples were collected using Tasso-Plus and simultaneously standard venous phlebotomy. Data was to be reported for Tasso-Plus vs. venous phlebotomy concentrations (same participants).
Outcome measures
| Measure |
Tasso-Plus (Serum)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using Tasso-Plus device.
|
Venous Phlebotomy (Venous)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using venous phlebotomy.
|
Tasso-M20 (Dried Blood)
n=5 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using Tasso-M20 device.
|
Standard Venous Phlebotomy (Plasma)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using standard venous phlebotomy.
|
|---|---|---|---|---|
|
Plasma Concentration of Zavegepant at 30 Minutes Post-dose on Day 1 of Period 1- Tasso Device Versus (vs.) Standard Venous Phlebotomy
|
16.50 Nanograms per milliliter
Standard Deviation 6.0977
|
17.87 Nanograms per milliliter
Standard Deviation 7.3648
|
2.843 Nanograms per milliliter
Standard Deviation 1.8095
|
8.367 Nanograms per milliliter
Standard Deviation 5.0720
|
PRIMARY outcome
Timeframe: 1-hour post-dose on Day 1 of Period 1Population: PK concentration analysis set: all enrolled participants who received 1 single IN dose of Zavegepant and provided at least 1 evaluable plasma concentration.
Tasso device used was Tasso-Plus (for liquid blood sample collection). In Period 1, for the treated participants PK samples were collected using Tasso-Plus and simultaneously standard venous phlebotomy. Data was to be reported for Tasso-Plus vs. venous phlebotomy concentrations (same participants).
Outcome measures
| Measure |
Tasso-Plus (Serum)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using Tasso-Plus device.
|
Venous Phlebotomy (Venous)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using venous phlebotomy.
|
Tasso-M20 (Dried Blood)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using Tasso-M20 device.
|
Standard Venous Phlebotomy (Plasma)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using standard venous phlebotomy.
|
|---|---|---|---|---|
|
Plasma Concentration of Zavegepant at 1 Hour Post-dose on Day 1 of Period 1- Tasso Device vs. Standard Venous Phlebotomy
|
11.56 Nanograms per milliliter
Standard Deviation 5.2627
|
12.73 Nanograms per milliliter
Standard Deviation 5.6686
|
2.278 Nanograms per milliliter
Standard Deviation 2.0138
|
7.083 Nanograms per milliliter
Standard Deviation 6.3027
|
PRIMARY outcome
Timeframe: 2-hours post-dose on Day 1 of Period 1Population: PK concentration analysis set: all enrolled participants who received 1 single IN dose of Zavegepant and provided at least 1 evaluable plasma concentration. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
Tasso device used was Tasso-Plus (for liquid blood sample collection). In Period 1, for the treated participants PK samples were collected using Tasso-Plus and simultaneously standard venous phlebotomy. Data was to be reported for Tasso-Plus vs. venous phlebotomy concentrations (same participants).
Outcome measures
| Measure |
Tasso-Plus (Serum)
n=6 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using Tasso-Plus device.
|
Venous Phlebotomy (Venous)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using venous phlebotomy.
|
Tasso-M20 (Dried Blood)
n=6 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using Tasso-M20 device.
|
Standard Venous Phlebotomy (Plasma)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using standard venous phlebotomy.
|
|---|---|---|---|---|
|
Plasma Concentration of Zavegepant at 2 Hours Post-dose on Day 1 of Period 1- Tasso Device vs. Standard Venous Phlebotomy
|
6.515 Nanograms per milliliter
Standard Deviation 3.3114
|
6.493 Nanograms per milliliter
Standard Deviation 3.1807
|
1.443 Nanograms per milliliter
Standard Deviation 1.3173
|
3.791 Nanograms per milliliter
Standard Deviation 3.0525
|
PRIMARY outcome
Timeframe: 4-hours post-dose on Day 1 of Period 1Population: PK concentration analysis set: all enrolled participants who received 1 single IN dose of Zavegepant and provided at least 1 evaluable plasma concentration. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
Tasso device used was Tasso-Plus (for liquid blood sample collection). In Period 1, for the treated participants PK samples were collected using Tasso-Plus and simultaneously standard venous phlebotomy. Data was to be reported for Tasso-Plus vs. venous phlebotomy concentrations (same participants).
Outcome measures
| Measure |
Tasso-Plus (Serum)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using Tasso-Plus device.
|
Venous Phlebotomy (Venous)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using venous phlebotomy.
|
Tasso-M20 (Dried Blood)
n=6 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using Tasso-M20 device.
|
Standard Venous Phlebotomy (Plasma)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using standard venous phlebotomy.
|
|---|---|---|---|---|
|
Plasma Concentration of Zavegepant at 4 Hours Post-dose on Day 1 of Period 1- Tasso Device vs. Standard Venous Phlebotomy
|
2.603 Nanograms per milliliter
Standard Deviation 1.2826
|
2.830 Nanograms per milliliter
Standard Deviation 1.3228
|
0.8087 Nanograms per milliliter
Standard Deviation 0.52981
|
1.638 Nanograms per milliliter
Standard Deviation 1.1138
|
PRIMARY outcome
Timeframe: 8-hours post-dose on Day 1 of Period 1Population: PK concentration analysis set: all enrolled participants who received 1 single IN dose of Zavegepant and provided at least 1 evaluable plasma concentration. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
Tasso device used was Tasso-Plus (for liquid blood sample collection). In Period 1, for the treated participants PK samples were collected using Tasso-Plus and simultaneously standard venous phlebotomy. Data was to be reported for Tasso-Plus vs. venous phlebotomy concentrations (same participants).
Outcome measures
| Measure |
Tasso-Plus (Serum)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using Tasso-Plus device.
|
Venous Phlebotomy (Venous)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using venous phlebotomy.
|
Tasso-M20 (Dried Blood)
n=6 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using Tasso-M20 device.
|
Standard Venous Phlebotomy (Plasma)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using standard venous phlebotomy.
|
|---|---|---|---|---|
|
Plasma Concentration of Zavegepant at 8 Hours Post-dose on Day 1 of Period 1- Tasso Device vs. Standard Venous Phlebotomy
|
0.7659 Nanograms per milliliter
Standard Deviation 0.34305
|
0.8424 Nanograms per milliliter
Standard Deviation 0.36412
|
0.4005 Nanograms per milliliter
Standard Deviation 0.23037
|
0.5300 Nanograms per milliliter
Standard Deviation 0.33164
|
PRIMARY outcome
Timeframe: 12-hours post-dose on Day 1 of Period 1Population: PK concentration analysis set: all enrolled participants who received 1 single IN dose of Zavegepant and provided at least 1 evaluable plasma concentration.
Tasso device used was Tasso-Plus (for liquid blood sample collection). In Period 1, for the treated participants PK samples were collected using Tasso-Plus and simultaneously standard venous phlebotomy. Data was to be reported for Tasso-Plus vs. venous phlebotomy concentrations (same participants).
Outcome measures
| Measure |
Tasso-Plus (Serum)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using Tasso-Plus device.
|
Venous Phlebotomy (Venous)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using venous phlebotomy.
|
Tasso-M20 (Dried Blood)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using Tasso-M20 device.
|
Standard Venous Phlebotomy (Plasma)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using standard venous phlebotomy.
|
|---|---|---|---|---|
|
Plasma Concentration of Zavegepant at 12 Hours Post-dose on Day 1 of Period 1- Tasso Device vs. Standard Venous Phlebotomy
|
0.3813 Nanograms per milliliter
Standard Deviation 0.16527
|
0.3969 Nanograms per milliliter
Standard Deviation 0.16154
|
0.3074 Nanograms per milliliter
Standard Deviation 0.19056
|
0.2753 Nanograms per milliliter
Standard Deviation 0.17468
|
PRIMARY outcome
Timeframe: Tasso: 0.5, 1, 2, 4, 8 and 12 hours post dose on Day 1 of Period 1; Venous: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post dose on Day 1 of Period 1Population: PK parameter analysis set included all enrolled participants who received 1 single IN dose of Zavegepant and provided at least 1 evaluable PK parameters of interest.
Tasso device used was Tasso-Plus (for liquid blood sample collection). In Period 1, for the treated participants PK samples were collected using Tasso-Plus and simultaneously standard venous phlebotomy. Data was to be reported for Tasso-Plus vs. venous phlebotomy concentrations (same participants).
Outcome measures
| Measure |
Tasso-Plus (Serum)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using Tasso-Plus device.
|
Venous Phlebotomy (Venous)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using venous phlebotomy.
|
Tasso-M20 (Dried Blood)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using Tasso-M20 device.
|
Standard Venous Phlebotomy (Plasma)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using standard venous phlebotomy.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Profile From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of Zavegepant: - Tasso Device vs. Standard Venous Phlebotomy
|
34.06 Nanogram*hour per milliliter
Geometric Coefficient of Variation 57
|
37.22 Nanogram*hour per milliliter
Geometric Coefficient of Variation 60
|
NA Nanogram*hour per milliliter
Geometric Coefficient of Variation NA
Data could not be calculated for Tasso-M20 (dried blood) reporting arm as the values were below the limit of quantification (BLQ).
|
NA Nanogram*hour per milliliter
Geometric Coefficient of Variation NA
Data could not be calculated for standard venous phlebotomy (plasma) reporting arm as the values were BLQ.
|
PRIMARY outcome
Timeframe: Tasso: 0.5, 1, 2, 4, 8 and 12 hours post dose on Day 1 of Period 1; Venous: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post dose on Day 1 of Period 1Population: PK parameter analysis set included all enrolled participants who received 1 single IN dose of Zavegepant and provided at least 1 evaluable PK parameters of interest.
Tasso device used was Tasso-Plus (for liquid blood sample collection). In Period 1, for the treated participants PK samples were collected using Tasso-Plus and simultaneously standard venous phlebotomy. Data was to be reported for Tasso-Plus vs. venous phlebotomy concentrations (same participants).
Outcome measures
| Measure |
Tasso-Plus (Serum)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using Tasso-Plus device.
|
Venous Phlebotomy (Venous)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using venous phlebotomy.
|
Tasso-M20 (Dried Blood)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using Tasso-M20 device.
|
Standard Venous Phlebotomy (Plasma)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using standard venous phlebotomy.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of Last Quantifiable Concentration (AUClast) of Zavegepant - Tasso Device vs. Standard Venous Phlebotomy
|
32.71 Nanogram*hour per milliliter
Geometric Coefficient of Variation 57
|
35.87 Nanogram*hour per milliliter
Geometric Coefficient of Variation 60
|
NA Nanogram*hour per milliliter
Geometric Coefficient of Variation NA
Data could not be calculated for Tasso-M20 (dried blood) reporting arm as the values were BLQ.
|
NA Nanogram*hour per milliliter
Geometric Coefficient of Variation NA
Data could not be calculated for standard venous phlebotomy (plasma) reporting arm as the values were BLQ.
|
PRIMARY outcome
Timeframe: Tasso: 0.5, 1, 2, 4, 8 and 12 hours post dose on Day 1 of Period 1; Venous: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post dose on Day 1 of Period 1Population: PK parameter analysis set included all enrolled participants who received 1 single IN dose of Zavegepant and provided at least 1 evaluable PK parameters of interest.
Tasso device used was Tasso-Plus (for liquid blood sample collection). In Period 1, for the treated participants PK samples were collected using Tasso-Plus and simultaneously standard venous phlebotomy. Data was to be reported for Tasso-Plus vs. venous phlebotomy concentrations (same participants).
Outcome measures
| Measure |
Tasso-Plus (Serum)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using Tasso-Plus device.
|
Venous Phlebotomy (Venous)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using venous phlebotomy.
|
Tasso-M20 (Dried Blood)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using Tasso-M20 device.
|
Standard Venous Phlebotomy (Plasma)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using standard venous phlebotomy.
|
|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Zavegepant - Tasso Device vs. Standard Venous Phlebotomy
|
14.88 Nanogram per milliliter
Geometric Coefficient of Variation 64
|
16.33 Nanogram per milliliter
Geometric Coefficient of Variation 70
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
Data could not be calculated for Tasso-M20 (dried blood) reporting arm as the values were BLQ.
|
NA Nanogram per milliliter
Geometric Coefficient of Variation NA
Data could not be calculated for standard venous phlebotomy (plasma) reporting arm as the values were BLQ.
|
PRIMARY outcome
Timeframe: Tasso: 0.5, 1, 2, 4, 8 and 12 hours post dose on Day 1 of Period 1; Venous: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post dose on Day 1 of Period 1Population: PK parameter analysis set included all enrolled participants who received 1 single IN dose of Zavegepant and provided at least 1 evaluable PK parameters of interest.
Tasso device used was Tasso-Plus (for liquid blood sample collection). In Period 1, for the treated participants PK samples were collected using Tasso-Plus and simultaneously standard venous phlebotomy. Data was to be reported for Tasso-Plus vs. venous phlebotomy concentrations (same participants).
Outcome measures
| Measure |
Tasso-Plus (Serum)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using Tasso-Plus device.
|
Venous Phlebotomy (Venous)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using venous phlebotomy.
|
Tasso-M20 (Dried Blood)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using Tasso-M20 device.
|
Standard Venous Phlebotomy (Plasma)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using standard venous phlebotomy.
|
|---|---|---|---|---|
|
Time for Cmax (Tmax) of Zavegepant - Tasso Device vs. Standard Venous Phlebotomy
|
0.517 Hours
Interval 0.5 to 1.03
|
0.500 Hours
Interval 0.5 to 1.0
|
NA Hours
Data could not be calculated for Tasso-M20 (dried blood) reporting arm as the values were BLQ.
|
NA Hours
Data could not be calculated for standard venous phlebotomy (plasma) reporting arm as the values were BLQ.
|
PRIMARY outcome
Timeframe: Tasso: 0.5, 1, 2, 4, 8 and 12 hours post dose on Day 1 of Period 1; Venous: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post dose on Day 1 of Period 1Population: PK parameter analysis set included all enrolled participants who received 1 single IN dose of Zavegepant and provided at least 1 evaluable PK parameters of interest.
t1/2 was calculated as loge (2) per kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Tasso device used was Tasso-Plus (for liquid blood sample collection). In Period 1, for the treated participants PK samples were collected using Tasso-Plus and simultaneously standard venous phlebotomy. Data was to be reported for Tasso-Plus vs. venous phlebotomy concentrations (same participants).
Outcome measures
| Measure |
Tasso-Plus (Serum)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using Tasso-Plus device.
|
Venous Phlebotomy (Venous)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using venous phlebotomy.
|
Tasso-M20 (Dried Blood)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using Tasso-M20 device.
|
Standard Venous Phlebotomy (Plasma)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using standard venous phlebotomy.
|
|---|---|---|---|---|
|
Terminal Half-Life (t1/2) of Zavegepant - Tasso Device vs. Standard Venous Phlebotomy
|
2.914 Hours
Standard Deviation 0.19069
|
3.819 Hours
Standard Deviation 1.7522
|
NA Hours
Standard Deviation NA
Data could not be calculated for Tasso-M20 (dried blood) reporting arm as the values were BLQ.
|
NA Hours
Standard Deviation NA
Data could not be calculated for standard venous phlebotomy (plasma) reporting arm as the values were BLQ.
|
PRIMARY outcome
Timeframe: Tasso: 0.5, 1, 2, 4, 8 and 12 hours post dose on Day 1 of Period 1; Venous: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post dose on Day 1 of Period 1Population: PK parameter analysis set included all enrolled participants who received 1 single IN dose of Zavegepant and provided at least 1 evaluable PK parameters of interest.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Tasso device used was Tasso-Plus (for liquid blood sample collection). In Period 1, for the treated participants PK samples were collected using Tasso-Plus and simultaneously standard venous phlebotomy. Data was to be reported for Tasso-Plus vs. venous phlebotomy concentrations (same participants).
Outcome measures
| Measure |
Tasso-Plus (Serum)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using Tasso-Plus device.
|
Venous Phlebotomy (Venous)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using venous phlebotomy.
|
Tasso-M20 (Dried Blood)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using Tasso-M20 device.
|
Standard Venous Phlebotomy (Plasma)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using standard venous phlebotomy.
|
|---|---|---|---|---|
|
Apparent Clearance (CL/F) of Zavegepant - Tasso Device vs. Standard Venous Phlebotomy
|
293.9 Liter per hour
Geometric Coefficient of Variation 57
|
268.9 Liter per hour
Geometric Coefficient of Variation 60
|
NA Liter per hour
Geometric Coefficient of Variation NA
Data could not be calculated for Tasso-M20 (dried blood) reporting arm as the values were BLQ.
|
NA Liter per hour
Geometric Coefficient of Variation NA
Data could not be calculated for standard venous phlebotomy (plasma) reporting arm as the values were BLQ.
|
PRIMARY outcome
Timeframe: Tasso: 0.5, 1, 2, 4, 8 and 12 hours post dose on Day 1 of Period 1; Venous: 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post dose on Day 1 of Period 1Population: PK parameter analysis set included all enrolled participants who received 1 single IN dose of Zavegepant and provided at least 1 evaluable PK parameters of interest.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F is influenced by the fraction absorbed. Tasso device used was Tasso-Plus (for liquid blood sample collection). In Period 1, for the treated participants PK samples were collected using Tasso-Plus and simultaneously standard venous phlebotomy. Data was to be reported for Tasso-Plus vs. venous phlebotomy concentrations (same participants).
Outcome measures
| Measure |
Tasso-Plus (Serum)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using Tasso-Plus device.
|
Venous Phlebotomy (Venous)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using venous phlebotomy.
|
Tasso-M20 (Dried Blood)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using Tasso-M20 device.
|
Standard Venous Phlebotomy (Plasma)
n=7 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using standard venous phlebotomy.
|
|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) of Zavegepant - Tasso Device vs. Standard Venous Phlebotomy
|
1232 Liter
Geometric Coefficient of Variation 56
|
1372 Liter
Geometric Coefficient of Variation 65
|
NA Liter
Geometric Coefficient of Variation NA
Data could not be calculated for Tasso-M20 (dried blood) reporting arm as the values were BLQ.
|
NA Liter
Geometric Coefficient of Variation NA
Data could not be calculated for standard venous phlebotomy (plasma) reporting arm as the values were BLQ.
|
SECONDARY outcome
Timeframe: From Day 1 of dosing up to 35 days post last dose of study drug (up to 37 days)Population: Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were defined as events from Day 1 of dosing up to 35 days post last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.
Outcome measures
| Measure |
Tasso-Plus (Serum)
n=14 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using Tasso-Plus device.
|
Venous Phlebotomy (Venous)
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using venous phlebotomy.
|
Tasso-M20 (Dried Blood)
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using Tasso-M20 device.
|
Standard Venous Phlebotomy (Plasma)
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using standard venous phlebotomy.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
9 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During study treatment (Day 1 of Period 1 and 2, 2 days)Population: Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Laboratory parameters criteria: a) Hematology: neutrophils/ leukocytes less than (\<) 0.8\* lower limit of normal (LLN); b) Urinalysis: urine hemoglobin was more than or equal to (\>=)1 and for bacteria \>20.
Outcome measures
| Measure |
Tasso-Plus (Serum)
n=14 Participants
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using Tasso-Plus device.
|
Venous Phlebotomy (Venous)
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using venous phlebotomy.
|
Tasso-M20 (Dried Blood)
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using Tasso-M20 device.
|
Standard Venous Phlebotomy (Plasma)
Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using standard venous phlebotomy.
|
|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
|
2 Participants
|
—
|
—
|
—
|
Adverse Events
Zavegepant
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Zavegepant
n=14 participants at risk
On Day 1 of Period 1, all participants received Zavegepant 10 mg via IN route (single use unidose nasal spray). Period 1 was followed by Period 2. On Day 1 of Period 2, all participants received a butterscotch candy and 5 minutes later received Zavegepant 10 mg single use unidose nasal spray. Participants were followed up 28-35 days after the second (last) dose.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
14.3%
2/14 • From Day 1 of dosing up to 35 days post last dose of study drug (up to 37 days)
|
|
Gastrointestinal disorders
Oral discomfort
|
7.1%
1/14 • From Day 1 of dosing up to 35 days post last dose of study drug (up to 37 days)
|
|
General disorders
Asthenia
|
7.1%
1/14 • From Day 1 of dosing up to 35 days post last dose of study drug (up to 37 days)
|
|
General disorders
Fatigue
|
7.1%
1/14 • From Day 1 of dosing up to 35 days post last dose of study drug (up to 37 days)
|
|
Injury, poisoning and procedural complications
Fall
|
7.1%
1/14 • From Day 1 of dosing up to 35 days post last dose of study drug (up to 37 days)
|
|
Injury, poisoning and procedural complications
Scar
|
21.4%
3/14 • From Day 1 of dosing up to 35 days post last dose of study drug (up to 37 days)
|
|
Injury, poisoning and procedural complications
Skin laceration
|
21.4%
3/14 • From Day 1 of dosing up to 35 days post last dose of study drug (up to 37 days)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
1/14 • From Day 1 of dosing up to 35 days post last dose of study drug (up to 37 days)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.1%
1/14 • From Day 1 of dosing up to 35 days post last dose of study drug (up to 37 days)
|
|
Nervous system disorders
Dizziness
|
14.3%
2/14 • From Day 1 of dosing up to 35 days post last dose of study drug (up to 37 days)
|
|
Nervous system disorders
Dysgeusia
|
14.3%
2/14 • From Day 1 of dosing up to 35 days post last dose of study drug (up to 37 days)
|
|
Nervous system disorders
Headache
|
28.6%
4/14 • From Day 1 of dosing up to 35 days post last dose of study drug (up to 37 days)
|
|
Nervous system disorders
Paraesthesia
|
7.1%
1/14 • From Day 1 of dosing up to 35 days post last dose of study drug (up to 37 days)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.1%
1/14 • From Day 1 of dosing up to 35 days post last dose of study drug (up to 37 days)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
14.3%
2/14 • From Day 1 of dosing up to 35 days post last dose of study drug (up to 37 days)
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
7.1%
1/14 • From Day 1 of dosing up to 35 days post last dose of study drug (up to 37 days)
|
|
Skin and subcutaneous tissue disorders
Eczema
|
7.1%
1/14 • From Day 1 of dosing up to 35 days post last dose of study drug (up to 37 days)
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
7.1%
1/14 • From Day 1 of dosing up to 35 days post last dose of study drug (up to 37 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER