HealthyPhase 1NCT06453356
A Study to Learn How the Study Medicine Called Zavegepant is Taken Up Into Blood and Breast Milk of Healthy Breast-Feeding Women
A Phase 1 study testing Zavegepant 10mg in people with Healthy, run by Pfizer at 2 sites in United States.
Trial summary
The purpose of the study is to look at the amount of zavegepant that is present in breast milk after single dose of zavegepant is sprayed through the nose in healthy breast-feeding women. This would allow to see if there are any possible risk to infants from medicines during breast-feeding. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Zavegepant 10mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Jun 2024to 26 Sep 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must meet the following key inclusion criteria to be eligible for enrollment into the study:
- Age and Sex:
- Healthy lactating females who are actively breast-feeding or expressing breast milk, who are at least 2 weeks post-partum and not currently pregnant (must have a negative pregnancy test), and must be 18 to 55 years of age, inclusive, at the time of signing the Informed Consent Document (ICD).
- Participants must be able to express at least 14 mL of breast milk over a 2-hour interval prior to the dose on Day 1.
- Other Inclusion Criteria:
- Body mass index (BMI) 16.0-34.9 kg/m2 and body weight ≥45.0 kg (99 lb).
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- Female participants with history of acute migraine are allowed.
- Participants must be willing to temporarily discontinue breastfeeding their infants for a total of 2.5 days (approximately 60 hours), ie, from the evening of the day before Day 1 through to 48 hours after the dose (approximately 8 AM the morning of Day 3). Participants must be willing to regularly pump breasts throughout the study and express breast milk according to a schedule designed to maintain lactation throughout the study period.
- Participants must agree that breast milk expressed following zavegepant administration through 48 hours after the dose should be discarded and will not be fed to any infant.
- -
Who cannot join
- Participants with any of the following characteristics/conditions will be excluded:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological (with exception of acute migraine), or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Clinically significant history of nasal conditions that may affect the administration or absorption of the nasal product (eg, severe septum deviation or nasal deformity, inflammation, perforation, mucosal erosion or ulceration, localized infection, congestion, polyposis, rhinorrhea, nasal surgery within the previous 6 months, or nasal trauma).
- Significant history of seizure disorder other than a single childhood febrile seizure (eg, epilepsy).
- History of gallstone or cholecystectomy.
- Any other medical or psychiatric condition, including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions or situations related to coronavirus disease 2019 (COVID-19) pandemic that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
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- Use of organic anion transporting polypeptide 1B3 (OATP1B3) inhibitors within 14 days or 5 half-lives, whichever is longer, before first dosing.
- Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to investigational product (IP) dosing, administration of a biological product in the context of a clinical research study within 90 days prior to IP dosing, or concomitant participation in an investigational study involving no drug or device administration.
- Any clinically significant abnormal laboratory test results or positive test found during medical screening. A single repeat for positive drug screen may be allowed at the discretion of the principal investigator (PI).
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination or nasal inspection beyond what is consistent with the target population.
- Participants with ANY of the following abnormalities in clinical laboratory tests at screening:
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level > 1.5 × upper limit of normal (ULN);
- Total bilirubin level >1.5 × ULN;
- Estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73m².
- Individuals who smoke more than 5 cigarettes or equivalent daily.
- Presence of piercings or any physical findings in the nose that, in the opinion of the PI, would likely interfere with the successful completion of the dosing procedure.
- Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
- History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1 ounce (30 mL) of 40% spirit, or 3 ounces (90 mL) of wine).
- Any reason that, in the opinion of the PI, would prevent the participant from participating in the study.
- -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Bio-Kinetic Clinical Applications, LLC dba QPS-MO
Springfield, Missouri, 65802
Bio-Kinetic Clinicals Applications LLC DBA QPS-MO Patient Screening and Recruitment Center Center)
Springfield, Missouri, 65807
About this study
Official title: A PHASE 1 SINGLE INTRANASAL DOSE, OPEN-LABEL PHARMACOKINETIC STUDY OF ZAVEGEPANT IN HEALTHY LACTATING WOMEN
The purpose of the study is to look at the amount of zavegepant that is present in breast milk after single dose of zavegepant is sprayed through the nose in healthy breast-feeding women. This would allow to see if there are any possible risk to infants from medicines during breast-feeding.
The study is seeking for about 12 healthy breast-feeding females who are:
Read more
- 18 to 55 years of age.
- actively breast-feeding or producing breast milk.
- at least 2 weeks post-partum and not pregnant at present. Participants will not be allowed to breast-feed their infant from the evening of the day before to the first dose till 48 hours (2 days) after the dose.
Eligible participants will check into the clinical research unit (CRU) on Day -1. Participants will receive the zavegepant dose sprayed into the nose at the CRU on Day 1. The participants will stay at the CRU until the morning of Day 2. There will be collections of breast milk and plasma over 24 hours. Participants will be sent from the CRU on Day 2 and may begin to breastfeed their infant 48 hours (2 days) after the dose. A safety follow-up call will be done at about 28 to 35 days from the day the first dose of study medicine was given.
- Conditions
- Healthy
- Being tested
- Zavegepant 10mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zavegepant 10mgDrug
Also called Zavzpret, PF-07930207
intransal spray 10mg
| Study group | Role | What they receive |
|---|---|---|
| Zavegepant 10mg | Experimental | Intranasal (IN) 10mg spray on Day 1 Receives: Drug: Zavegepant 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Breast Milk Concentration-time Profile from time 0 extrapolated to infinite time (AUCinf), if data permit
AUCinf = Area under the breast milk concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
Measured: 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 16, 16 to 24 hours
Area Under the Breast Milk Concentration-time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast)
Area under the breast milk concentration time-curve from zero to the last measured concentration (AUClast)
Measured: 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 16, 16 to 24 hours
Area Under the Breast Milk Concentration-time Profile From Time Zero to the Time of 24 hr post dose (AUC24)
AUC24= Area under the breast milk concentration versus time curve from time zero (pre-dose) to time 24 hours
Measured: 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 16, 16 to 24 hours
Maximum observed breast milk concentration (Cmax)
Measured: 0 to 24 hours post dose
Time for Cmax in Breast Milk (Tmax)
Measured: 0 to 24 hours post dose
Terminal half-life for breast milk (t 1/2), if data permit
Measured: 0 to 24 hours post dose
Secondary outcomes (14)
Area under the concentration-time profile from time 0 extrapolated to infinite time (AUCinf), if data permit
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
Measured: 0 to 24 hours post dose
Area under the concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast)
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Measured: 0 to 24 hours post dose
Area under the concentration-time profile from time 0 to 24 hours post dose (AUC24)
AUC24= Area under the plasma concentration versus time curve from time zero (pre-dose) to time 24 hours
Measured: 0 to 24 hours post dose
Maximum observed plasma concentration (Cmax)
Measured: 0 to 24 hours post dose
Time for plasma Cmax (Tmax)
Measured: 0 to 24 hours post dose
Plasma Terminal half-life (t 1/2), if data permit
Measured: 0 to 24 hours post dose
Average plasma concentration (Cav) over 24 hr
Measured: 0 to 24 hours post dose
Breast milk to plasma ratio for AUCinf (MPAUCinf), if data permit
Measured: 0 to 24 hours post dose
Breast milk to plasma ratio (MPAUC24) for AUC24, if data permit
Measured: 0 to 24 hours post dose
Breast milk to plasma ratio for Cmax (MPCmax)
Measured: 0 to 24 hours post dose
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured: From Day 1 up to at least 28 days after last dose of study drug
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Measured: 0 to 24 hours post dose
Number of Participants With Clinically Significant Change from Baseline in Electrocardiogram (ECG) Parameters
Measured: 0 to 24 hours post dose
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Measured: 0 to 24 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start10 Jun 2024
- Primary completion26 Sep 2024
- Study completion26 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453356
- Sponsor's protocol ID
- C5301032
- Status last verified
- Oct 2024
- First submitted
- 28 May 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Jakate A, Weng Y, Shkrodova A, Fisniku O, Ding D, Morton K, Maligalig B, Garnick P, Liu J, Shahin MH. A phase 1 study of the breast milk and plasma pharmacokinetics of zavegepant 10 mg intranasal dose in healthy lactating women. Headache. 2026 May;66(5):1050-1057. doi: 10.1111/head.70036. Epub 2026 Jan 8.
PubMed 41502343
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1 SINGLE INTRANASAL DOSE, OPEN-LABEL PHARMACOKINETIC STUDY OF ZAVEGEPANT IN HEALTHY LACTATING WOMEN
- ClinicalTrials.gov ID
- NCT06453356
- Acronym / sponsor ID
- C5301032
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 26 Sep 2024 (actual)
- Study completion
- 26 Sep 2024 (actual)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to look at the amount of zavegepant that is present in breast milk after single dose of zavegepant is sprayed through the nose in healthy breast-feeding women. This would allow to see if there are any possible risk to infants from medicines during breast-feeding.
The study is seeking for about 12 healthy breast-feeding females who are:
- 18 to 55 years of age.
- actively breast-feeding or producing breast milk.
- at least 2 weeks post-partum and not pregnant at present. Participants will not be allowed to breast-feed their infant from the evening of the day before to the first dose till 48 hours (2 days) after the dose.
Eligible participants will check into the clinical research unit (CRU) on Day -1. Participants will receive the zavegepant dose sprayed into the nose at the CRU on Day 1. The participants will stay at the CRU until the morning of Day 2. There will be collections of breast milk and plasma over 24 hours. Participants will be sent from the CRU on Day 2 and may begin to breastfeed their infant 48 hours (2 days) after the dose. A safety follow-up call will be done at about 28 to 35 days from the day the first dose of study medicine was given.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zavegepant 10mg | Experimental | Drug: Zavegepant 10mgIntranasal (IN) 10mg spray on Day 1 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Participants must meet the following key inclusion criteria to be eligible for enrollment into the study:
- Healthy lactating females who are actively breast-feeding or expressing breast milk, who are at least 2 weeks post-partum and not currently pregnant (must have a negative pregnancy test), and must be 18 to 55 years of age, inclusive, at the time of signing the Informed Consent Document (ICD).
- Body mass index (BMI) 16.0-34.9 kg/m2 and body weight ≥45.0 kg (99 lb).
- Female participants with history of acute migraine are allowed.
- Participants must be willing to temporarily discontinue breastfeeding their infants for a total of 2.5 days (approximately 60 hours), ie, from the evening of the day before Day 1 through to 48 hours after the dose (approximately 8 AM the morning of Day 3). Participants must be willing to regularly pump breasts throughout the study and express breast milk according to a schedule designed to maintain lactation throughout the study period.
Key exclusion criteria (20 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological (with exception of acute migraine), or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Clinically significant history of nasal conditions that may affect the administration or absorption of the nasal product (eg, severe septum deviation or nasal deformity, inflammation, perforation, mucosal erosion or ulceration, localized infection, congestion, polyposis, rhinorrhea, nasal surgery within the previous 6 months, or nasal trauma).
- Significant history of seizure disorder other than a single childhood febrile seizure (eg, epilepsy).
- History of gallstone or cholecystectomy.
- Any other medical or psychiatric condition, including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions or situations related to coronavirus disease 2019 (COVID-19) pandemic that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zavegepant 10mgAlso: Zavzpret, PF-07930207intransal spray 10mg | Drug | Zavegepant 10mg |
Primary outcome
Area Under the Breast Milk Concentration-time Profile from time 0 extrapolated to infinite time (AUCinf), if data permit
Time frame: 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 16, 16 to 24 hours
AUCinf = Area under the breast milk concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
Area Under the Breast Milk Concentration-time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast)
Time frame: 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 16, 16 to 24 hours
Area under the breast milk concentration time-curve from zero to the last measured concentration (AUClast)
Area Under the Breast Milk Concentration-time Profile From Time Zero to the Time of 24 hr post dose (AUC24)
Time frame: 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 16, 16 to 24 hours
AUC24= Area under the breast milk concentration versus time curve from time zero (pre-dose) to time 24 hours
Maximum observed breast milk concentration (Cmax)
Time frame: 0 to 24 hours post dose
Time for Cmax in Breast Milk (Tmax)
Time frame: 0 to 24 hours post dose
Terminal half-life for breast milk (t 1/2), if data permit
Time frame: 0 to 24 hours post dose
14 secondary outcomes
Area under the concentration-time profile from time 0 extrapolated to infinite time (AUCinf), if data permit
Time frame: 0 to 24 hours post dose
Area under the concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast)
Time frame: 0 to 24 hours post dose
Area under the concentration-time profile from time 0 to 24 hours post dose (AUC24)
Time frame: 0 to 24 hours post dose
Maximum observed plasma concentration (Cmax)
Time frame: 0 to 24 hours post dose
Time for plasma Cmax (Tmax)
Time frame: 0 to 24 hours post dose
Plasma Terminal half-life (t 1/2), if data permit
Time frame: 0 to 24 hours post dose
Average plasma concentration (Cav) over 24 hr
Time frame: 0 to 24 hours post dose
Breast milk to plasma ratio for AUCinf (MPAUCinf), if data permit
Time frame: 0 to 24 hours post dose
Breast milk to plasma ratio (MPAUC24) for AUC24, if data permit
Time frame: 0 to 24 hours post dose
Breast milk to plasma ratio for Cmax (MPCmax)
Time frame: 0 to 24 hours post dose
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: From Day 1 up to at least 28 days after last dose of study drug
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Time frame: 0 to 24 hours post dose
Number of Participants With Clinically Significant Change from Baseline in Electrocardiogram (ECG) Parameters
Time frame: 0 to 24 hours post dose
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time frame: 0 to 24 hours post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Derived from this study: PubMed 41502343Jakate A, Weng Y, Shkrodova A, Fisniku O, Ding D, Morton K, Maligalig B, Garnick P, Liu J, Shahin MH. A phase 1 study of the breast milk and plasma pharmacokinetics of zavegepant 10 mg intranasal dose in healthy lactating women. Headache. 2026 May;66(5):1050-1057. doi: 10.1111/head.70036. Epub 2026 Jan 8.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Zavegepant 10mg in people with Healthy, run by Pfizer at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Breast Milk Concentration-time Profile from time 0 extrapolated to infinite time (AUCinf), if data permit (time frame: 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 16, 16 to 24 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06453356, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.