Healthy
Conditions
Keywords
Zavegepant, Healthy volunteer
Brief summary
The purpose of this study is to learn about: * how Zavegepant is changed and removed from the body after taken. * safety of Zavegepant. * the extent to which side effects can be tolerated after taking Zavegepant for the possible short-term treatment of migraine. This study is seeking participants who: * are healthy Chinese adults and includes participants who are between 18 to 55 years old. * have body mass index (BMI) of 18 to 30 kg/m\^2. * have a total body weight of: * equal to or more than 50 kilograms (110 pounds) for males. * equal to or more than 45 kilograms (99 pounds) for females. * are non-smoker (no use of tobacco or nicotine products). 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.
Interventions
DRUGZavegepant
Participants receiving single dose of Zavegepant 10 mg
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy Chinese adults and includes participants who are between 18 to 55 years old * BMI of 18 to 30 kg/m\^2; and a total body weight ≥50 kg (110 lb) for males and ≥45 kg (99 lb) for females * Non-smoker (no use of tobacco or nicotine products).
Exclusion criteria
* Evidence or history of clinically significant disease. * Use of medication other than topical products without significant systemic absorption. * Previous participantion in a clinical research study or investigational study prior to the first dosing. * Any clinically significant abnormal laboratory test results or positive test. * Evidence of organ dysfunction or any clinically significant deviation from normal. * Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic). * Standard 12-lead ECG that demonstrates clinically relevant abnormalities. * Abnormalities in clinical laboratory tests: AST or ALT level \> ULN; Total bilirubin level \> ULN; ANC or ALC level \> ULN. * Positive urine drug screen, alcohol breath test, or urine cotinine test. * Positive pregnancy test. * Positive result for COVID-19. * History of significant alcohol abuse or drug abuse. * History of anaphylaxix reaction or a clinically important reaction to any drug. * Donation of plasma within 30 days prior to dosing. Donation or loss of blood of approximately 400 mL or more within 60 days prior to dosing. * Inability to be venipunctured and/or tolerate catheter venous access. * Habitual use of snuff tobacco. * History of sensitivity to heparin or heparin-induced thrombocytopenia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN | 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 | Maximum plasma concentration (Cmax) was measured. |
| AUClast of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN | 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, area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast), was measured. |
| AUCinf of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN | 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, area under the plasma concentration-time curve from time 0 extrapolated to infinite time, was measured. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | Tmax, time to Cmax, was measured. |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Day 1 up to maximum of 35 days post single dose administration | 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. |
| CL/F of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN | 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, apparent clearance, was measured. |
| Vz/F of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN | 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, apparent volume of distribution, was measured. |
| t1/2 of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN | 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, terminal half-life, was measured. |
| 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 | — |
Countries
China
Participant flow
Recruitment details
A total of 13 participants were enrolled and 12 participants received 1 dose of study intervention, and all 12 participants completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Zavegepant IN 10 mg Zavegepant 10 mg was administered intranasally (IN) on Day 1. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Zavegepant IN 10 mg |
|---|---|
| Age, Customized 18-25 Years | 3 Participants |
| Age, Customized <18 Years | 0 Participants |
| Age, Customized 26-35 Years | 6 Participants |
| Age, Customized 36-45 Years | 3 Participants |
| Age, Customized >45 Years | 0 Participants |
| Race/Ethnicity, Customized Asian | 12 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 12 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 4 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
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.
Time frame: 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
Population: The analysis population refers to all participants who were dosed and had at least 1 of the PK parameters of primary interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Zavegepant IN 10 mg | AUCinf of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN | 53.53 ng*hr/mL | Geometric Coefficient of Variation 128 |
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.
Time frame: 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
Population: The analysis population refers to all participants who were dosed and had at least 1 of the PK parameters of primary interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Zavegepant IN 10 mg | AUClast of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN | 44.25 ng*hour/mL | Geometric Coefficient of Variation 122 |
Primary
Cmax of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN
Maximum plasma concentration (Cmax) was measured.
Time frame: 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
Population: The analysis population refers to all participants who were dosed and had at least 1 of the PK parameters of primary interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Zavegepant IN 10 mg | Cmax of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN | 20.32 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 114 |
Secondary
CL/F of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN
CL/F, apparent clearance, was measured.
Time frame: 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
Population: The analysis population refers to all participants who were dosed and had at least 1 of the PK parameters of secondary interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Zavegepant IN 10 mg | CL/F of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN | 186.8 Liter/hr | Geometric Coefficient of Variation 128 |
Secondary
Number of Participants With Clinically Significant Values of 12-lead ECGs
Time frame: Day 1 up to maximum of 35 days post single dose administration
Population: All participants who took study intervention were included in the safety analysis set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zavegepant IN 10 mg | Number of Participants With Clinically Significant Values of 12-lead ECGs | 0 Participants |
Secondary
Number of Participants With Clinically Significant Values of Vital Signs
Time frame: Day 1 up to maximum of 35 days post single dose administration
Population: All participants who took study intervention were included in the safety analysis set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zavegepant IN 10 mg | Number of Participants With Clinically Significant Values of Vital Signs | 0 Participants |
Secondary
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Time frame: Day 1 up to maximum of 35 days post single dose administration
Population: All participants who took study intervention were included in the safety analysis set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zavegepant IN 10 mg | Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) | 1 Participants |
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.
Time frame: Day 1 up to maximum of 35 days post single dose administration
Population: All participants who took study intervention were included in the safety analysis set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Zavegepant IN 10 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | With all-causality TEAEs | 4 Participants |
| Zavegepant IN 10 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | With treatment-related TEAEs | 3 Participants |
Secondary
t1/2 of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN
T1/2, terminal half-life, was measured.
Time frame: 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
Population: The analysis population refers to all participants who were dosed and had at least 1 of the PK parameters of secondary interest.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zavegepant IN 10 mg | t1/2 of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN | 11.00 hour | Standard Deviation 1.4929 |
Secondary
Tmax of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN
Tmax, time to Cmax, was measured.
Time frame: 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
Population: The analysis population refers to all participants who were dosed and had at least 1 of the PK parameters of secondary interest.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zavegepant IN 10 mg | Tmax of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN | 0.584 hour |
Secondary
Vz/F of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN
Vz/F, apparent volume of distribution, was measured.
Time frame: 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
Population: The analysis population refers to all participants who were dosed and had at least 1 of the PK parameters of secondary interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Zavegepant IN 10 mg | Vz/F of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN | 2943 Liter | Geometric Coefficient of Variation 141 |