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| ID | Type | Description | Link |
|---|---|---|---|
| NCT05948085 | Registry Identifier | ClinicalTrials.gov |
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The purpose of this clinical trial is to learn about the pharmacokinetics and safety of a drug called zavegepant from samples collected using a patient-centric device called Tasso-Plus (for liquid blood sample collection) and Tasso-M20 (for dried blood sample collection) compared to standard venous sample collection. This study consists of two periods and will enroll approximately 14 healthy participants. In period 1, half of the enrolled participants (n=7) will use Tasso-Plus, and the other 50% (n=7) will use Tasso-M20. For each participant, PK samples will be collected after zavegepant administration in period 1 using the assigned Tasso device simultaneously with collecting venous blood samples. In addition, taste assessments will be performed at time intervals of 1 (immediately after dosing), 5, 10 and 20 minutes after zavegepant IN administration. Also, if feasible, 4 Japanese participants will be enrolled among those 14 participants to evaluate the PK and safety of zavegepant IN in Japanese vs. non Japanese participants. In period 2, a butterscotch candy will be given 5 minutes before administering the zavegepant IN study intervention. Taste assessment will also be performed after zavegepant IN administration with a butterscotch candy in period 2. For taste assessment, each participant will record the sensory attributes at timed intervals of 1 (immediately after dosing), 5, 10 and 20 minutes after zavegepant administration in each period. The expected duration of participation from screening until follow-up telephone contact is approximately 9 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zavegepant 10 mg Intranasal (IN) | Experimental | All participants will receive zavegepant 10 mg IN spray in period 1 and a butterscotch candy + zavegepant 10 mg IN spray in period 2 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zavegepant 10 mg IN | Drug | All participants will receive zavegepant 10 mg IN spray in period 1 and a butterscotch candy + zavegepant 10 mg IN spray in period 2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of Zavegepant at 30 Minutes Post-dose on Day 1 of Period 1- Tasso Device Versus (vs.) Standard Venous Phlebotomy | 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). | 30 minutes post-dose on Day 1 of Period 1 |
| Plasma Concentration of Zavegepant at 1 Hour Post-dose on Day 1 of Period 1- Tasso Device vs. Standard Venous Phlebotomy | 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). | 1-hour post-dose on Day 1 of Period 1 |
| Plasma Concentration of Zavegepant at 2 Hours Post-dose on Day 1 of Period 1- Tasso Device vs. Standard Venous Phlebotomy | 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). | 2-hours post-dose on Day 1 of Period 1 |
| Plasma Concentration of Zavegepant at 4 Hours Post-dose on Day 1 of Period 1- Tasso Device vs. Standard Venous Phlebotomy | 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). | 4-hours post-dose on Day 1 of Period 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit - New Haven | New Haven | Connecticut | 06511 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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A total of 14 participants were enrolled in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 (2 Days) |
| |||||||||||||
| Treatment Period 2 (2 Days) |
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Baseline characteristics analysis was evaluated on all enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Zavegepant | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Plasma Concentration of Zavegepant at 30 Minutes Post-dose on Day 1 of Period 1- Tasso Device Versus (vs.) Standard Venous Phlebotomy | 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). | 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. | Posted | Mean | Standard Deviation | Nanograms per milliliter | 30 minutes post-dose on Day 1 of Period 1 |
|
From Day 1 of dosing up to 35 days post last dose of study drug (up to 37 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zavegepant | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 12, 2023 | Aug 28, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 9, 2023 | Aug 28, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Plasma Concentration of Zavegepant at 8 Hours Post-dose on Day 1 of Period 1- Tasso Device vs. Standard Venous Phlebotomy |
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). |
| 8-hours post-dose on Day 1 of Period 1 |
| Plasma Concentration of Zavegepant at 12 Hours Post-dose on Day 1 of Period 1- Tasso Device vs. Standard Venous Phlebotomy | 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). | 12-hours post-dose on Day 1 of Period 1 |
| Area Under the Plasma Concentration-Time Profile From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of Zavegepant: - Tasso Device vs. Standard Venous Phlebotomy | 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). | 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 |
| 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 | 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). | 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 |
| Maximum Plasma Concentration (Cmax) of Zavegepant - Tasso Device vs. Standard Venous Phlebotomy | 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). | 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 |
| Time for Cmax (Tmax) of Zavegepant - Tasso Device vs. Standard Venous Phlebotomy | 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). | 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 |
| Terminal Half-Life (t1/2) of Zavegepant - Tasso Device vs. Standard Venous Phlebotomy | 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). | 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 |
| Apparent Clearance (CL/F) of Zavegepant - Tasso Device vs. Standard Venous Phlebotomy | 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). | 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 |
| Apparent Volume of Distribution (Vz/F) of Zavegepant - Tasso Device vs. Standard Venous Phlebotomy | 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). | 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 |
| From Day 1 of dosing up to 35 days post last dose of study drug (up to 37 days) |
| Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) | 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. | During study treatment (Day 1 of Period 1 and 2, 2 days) |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Venous Phlebotomy (Venous) | Participants received Zavegepant 10 mg via IN route on Day 1 of Period 1. PK samples were collected using venous phlebotomy. |
| OG002 | 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. |
| OG003 | 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. |
|
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| Primary | Plasma Concentration of Zavegepant at 1 Hour Post-dose on Day 1 of Period 1- Tasso Device vs. Standard Venous Phlebotomy | 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). | PK concentration analysis set: all enrolled participants who received 1 single IN dose of Zavegepant and provided at least 1 evaluable plasma concentration. | Posted | Mean | Standard Deviation | Nanograms per milliliter | 1-hour post-dose on Day 1 of Period 1 |
|
|
|
| Primary | Plasma Concentration of Zavegepant at 2 Hours Post-dose on Day 1 of Period 1- Tasso Device vs. Standard Venous Phlebotomy | 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). | 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. | Posted | Mean | Standard Deviation | Nanograms per milliliter | 2-hours post-dose on Day 1 of Period 1 |
|
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| Primary | Plasma Concentration of Zavegepant at 4 Hours Post-dose on Day 1 of Period 1- Tasso Device vs. Standard Venous Phlebotomy | 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). | 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. | Posted | Mean | Standard Deviation | Nanograms per milliliter | 4-hours post-dose on Day 1 of Period 1 |
|
|
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| Primary | Plasma Concentration of Zavegepant at 8 Hours Post-dose on Day 1 of Period 1- Tasso Device vs. Standard Venous Phlebotomy | 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). | 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. | Posted | Mean | Standard Deviation | Nanograms per milliliter | 8-hours post-dose on Day 1 of Period 1 |
|
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| Primary | Plasma Concentration of Zavegepant at 12 Hours Post-dose on Day 1 of Period 1- Tasso Device vs. Standard Venous Phlebotomy | 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). | PK concentration analysis set: all enrolled participants who received 1 single IN dose of Zavegepant and provided at least 1 evaluable plasma concentration. | Posted | Mean | Standard Deviation | Nanograms per milliliter | 12-hours post-dose on Day 1 of Period 1 |
|
|
|
| Primary | Area Under the Plasma Concentration-Time Profile From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of Zavegepant: - Tasso Device vs. Standard Venous Phlebotomy | 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). | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram*hour per milliliter | 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 |
|
|
|
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| Primary | 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 | 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). | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram*hour per milliliter | 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 |
|
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| Primary | Maximum Plasma Concentration (Cmax) of Zavegepant - Tasso Device vs. Standard Venous Phlebotomy | 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). | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | 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 |
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| Primary | Time for Cmax (Tmax) of Zavegepant - Tasso Device vs. Standard Venous Phlebotomy | 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). | 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. | Posted | Median | Full Range | Hours | 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 |
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| Primary | Terminal Half-Life (t1/2) of Zavegepant - Tasso Device vs. Standard Venous Phlebotomy | 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). | 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. | Posted | Mean | Standard Deviation | Hours | 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 |
|
|
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| Primary | Apparent Clearance (CL/F) of Zavegepant - Tasso Device vs. Standard Venous Phlebotomy | 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). | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter per hour | 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 |
|
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| Primary | Apparent Volume of Distribution (Vz/F) of Zavegepant - Tasso Device vs. Standard Venous Phlebotomy | 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). | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter | 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 |
|
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 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. | 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. | Posted | Count of Participants | Participants | From Day 1 of dosing up to 35 days post last dose of study drug (up to 37 days) |
|
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| Secondary | Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) | 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. | 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. | Posted | Count of Participants | Participants | During study treatment (Day 1 of Period 1 and 2, 2 days) |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 9 |
| 14 |
| Oral discomfort | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA v26.0 | Non-systematic Assessment |
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| Scar | Injury, poisoning and procedural complications | MedDRA v26.0 | Non-systematic Assessment |
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| Skin laceration | Injury, poisoning and procedural complications | MedDRA v26.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
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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.
| D009422 | Nervous System Diseases |