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The purpose of this study is to learn about:
This study is seeking participants who:
All participants in this study will receive Zavegepant by nose, once at the study clinic.
The experiences of the participants receiving the study medicine will be looked at. This will help see if the study medicine is safe.
Participants will take part in this study for around 9 weeks. During this time, participants will have 2 study visits at the study clinic and 1 contact over the phone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zavegepant | Experimental | Participants receiving Zavegepant for the treatment phase of the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zavegepant | Drug | Participants receiving single dose of Zavegepant 10 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN | Maximum plasma concentration (Cmax) was measured. | 0 (pre-dose), 5 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose on Day 1 |
| AUClast of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN | AUClast, area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast), was measured. | 0 (pre-dose), 5 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose on Day 1 |
| AUCinf of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN | AUCinf, area under the plasma concentration-time curve from time 0 extrapolated to infinite time, was measured. | 0 (pre-dose), 5 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose on Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention, including untoward findings on physical examinations captured as AEs if any. | Day 1 up to maximum of 35 days post single dose administration |
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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 |
|---|---|---|---|---|---|---|
| Huashan Hospital,Fudan University | Shanghai | Shanghai Municipality | 201107 | China |
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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 13 participants were enrolled and 12 participants received 1 dose of study intervention, and all 12 participants completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Zavegepant IN 10 mg | Zavegepant 10 mg was administered intranasally (IN) on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| TREATMENT |
| ||||||||||||||||
| FOLLOW-UP |
|
Participants who received study treatments were included in baseline analysis population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Zavegepant IN 10 mg | Zavegepant 10 mg was administered intranasally (IN) on Day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 | Cmax of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN | Maximum plasma concentration (Cmax) was measured. | The analysis population refers to all participants who were dosed and had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | 0 (pre-dose), 5 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose on Day 1 |
|
|
Day 1 up to maximum of 35 days post single dose administration
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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 IN 10 mg | Zavegepant 10 mg was administered intranasally (IN) on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Laryngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquires@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 | Feb 20, 2023 | Nov 14, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 17, 2023 | Nov 14, 2024 | SAP_001.pdf |
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| Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) | Day 1 up to maximum of 35 days post single dose administration |
| Number of Participants With Clinically Significant Values of Vital Signs | Day 1 up to maximum of 35 days post single dose administration |
| Number of Participants With Clinically Significant Values of 12-lead ECGs | Day 1 up to maximum of 35 days post single dose administration |
| Tmax of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN | Tmax, time to Cmax, was measured. | 0 (pre-dose), 5 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose on Day 1 |
| t1/2 of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN | T1/2, terminal half-life, was measured. | 0 (pre-dose), 5 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose on Day 1 |
| CL/F of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN | CL/F, apparent clearance, was measured. | 0 (pre-dose), 5 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose on Day 1 |
| Vz/F of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN | Vz/F, apparent volume of distribution, was measured. | 0 (pre-dose), 5 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose on Day 1 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | AUClast of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN | AUClast, area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast), was measured. | The analysis population refers to all participants who were dosed and had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hour/mL | 0 (pre-dose), 5 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose on Day 1 |
|
|
|
| Primary | AUCinf of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN | AUCinf, area under the plasma concentration-time curve from time 0 extrapolated to infinite time, was measured. | The analysis population refers to all participants who were dosed and had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | 0 (pre-dose), 5 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose on Day 1 |
|
|
|
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention, including untoward findings on physical examinations captured as AEs if any. | All participants who took study intervention were included in the safety analysis set. | Posted | Count of Participants | Participants | Day 1 up to maximum of 35 days post single dose administration |
|
|
|
| Secondary | Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) | All participants who took study intervention were included in the safety analysis set. | Posted | Count of Participants | Participants | Day 1 up to maximum of 35 days post single dose administration |
|
|
|
| Secondary | Number of Participants With Clinically Significant Values of Vital Signs | All participants who took study intervention were included in the safety analysis set. | Posted | Count of Participants | Participants | Day 1 up to maximum of 35 days post single dose administration |
|
|
|
| Secondary | Number of Participants With Clinically Significant Values of 12-lead ECGs | All participants who took study intervention were included in the safety analysis set. | Posted | Count of Participants | Participants | Day 1 up to maximum of 35 days post single dose administration |
|
|
|
| Secondary | Tmax of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN | Tmax, time to Cmax, was measured. | The analysis population refers to all participants who were dosed and had at least 1 of the PK parameters of secondary interest. | Posted | Median | Full Range | hour | 0 (pre-dose), 5 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose on Day 1 |
|
|
|
| Secondary | t1/2 of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN | T1/2, terminal half-life, was measured. | The analysis population refers to all participants who were dosed and had at least 1 of the PK parameters of secondary interest. | Posted | Mean | Standard Deviation | hour | 0 (pre-dose), 5 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose on Day 1 |
|
|
|
| Secondary | CL/F of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN | CL/F, apparent clearance, was measured. | The analysis population refers to all participants who were dosed and had at least 1 of the PK parameters of secondary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter/hr | 0 (pre-dose), 5 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose on Day 1 |
|
|
|
| Secondary | Vz/F of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN | Vz/F, apparent volume of distribution, was measured. | The analysis population refers to all participants who were dosed and had at least 1 of the PK parameters of secondary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter | 0 (pre-dose), 5 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose on Day 1 |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 4 |
| 12 |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Nasal mucosal discolouration | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Nasal mucosal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Urticaria papular | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
|
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.