HealthyPhase 1NCT05960032

A Study to Learn About the Study Medicine Called Zavegepant in Healthy Chinese Adult Participants

A Phase 1 study testing Zavegepant in people with Healthy, run by Pfizer at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Zavegepant
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 1 siteChina
Study dates: 23 Oct 2023to 12 Dec 2023
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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).

Who cannot join

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).

Show all 17Show fewer

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Huashan Hospital,Fudan University
Shanghai, Shanghai Municipality, 201107

Other trials in China

About this study

Official title: A PHASE 1, OPEN-LABEL, SINGLE DOSE STUDY TO INVESTIGATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF ZAVEGEPANT INTRANASAL ADMINISTRATION IN HEALTHY CHINESE ADULT PARTICIPANTS

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.

Conditions: Healthy
Being tested: Zavegepant
Keywords: Zavegepant, Healthy volunteer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ZavegepantDrug
Participants receiving single dose of Zavegepant 10 mg

Study groups in NCT05960032
Study group	Role	What they receive
Zavegepant	Experimental	Participants receiving Zavegepant for the treatment phase of the study Receives: Drug: Zavegepant

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN
Maximum plasma concentration (Cmax) was measured.
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.
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.
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

Secondary outcomes (8)

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.
Measured: Day 1 up to maximum of 35 days post single dose administration
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Measured: Day 1 up to maximum of 35 days post single dose administration
Number of Participants With Clinically Significant Values of Vital Signs
Measured: Day 1 up to maximum of 35 days post single dose administration
Number of Participants With Clinically Significant Values of 12-lead ECGs
Measured: 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.
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.
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.
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.
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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Oct 202312 Dec 2023

First posted25 Jul 2023
Study start23 Oct 2023
Primary completion12 Dec 2023
Study completion12 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05960032
Sponsor's protocol ID: C5301009
Status last verified: Nov 2024
First submitted: 16 Jul 2023
Last updated: 6 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1, OPEN-LABEL, SINGLE DOSE STUDY TO INVESTIGATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF ZAVEGEPANT INTRANASAL ADMINISTRATION IN HEALTHY CHINESE ADULT PARTICIPANTS
ClinicalTrials.gov ID: NCT05960032
Acronym / sponsor ID: C5301009
Conditions: Healthy
Keywords: Zavegepant, Healthy volunteer
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 23 Oct 2023 (actual)
Primary completion: 12 Dec 2023 (actual)
Study completion: 12 Dec 2023 (actual)
First posted: 25 Jul 2023 (actual)
Results: Posted 6 Jan 2025

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 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.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Zavegepant	Experimental	Drug: ZavegepantParticipants receiving Zavegepant for the treatment phase of the study

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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).

Key exclusion criteria (17 listed)

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.

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
ZavegepantParticipants receiving single dose of Zavegepant 10 mg	Drug	Zavegepant

Primary outcome

Cmax of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN
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
Maximum plasma concentration (Cmax) was measured.
AUClast of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN
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
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
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
AUCinf, area under the plasma concentration-time curve from time 0 extrapolated to infinite time, was measured.

8 secondary outcomes

Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 up to maximum of 35 days post single dose administration
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
Number of Participants With Clinically Significant Values of Vital Signs
Time frame: Day 1 up to maximum of 35 days post single dose administration
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
Tmax of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN
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
t1/2 of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN
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
CL/F of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN
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
Vz/F of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN
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

Results and safety

Results posted to the registry on 6 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Zavegepant IN 10 mg	12	12

Primary outcome: Cmax of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN

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. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram per milliliter (ng/mL)

Measure	Zavegepant IN 10 mg n = 12
Value	20.32 (114)

Population analysed: The analysis population refers to all participants who were dosed and had at least 1 of the PK parameters of primary interest.

Primary outcome: AUClast of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN

Measure	Zavegepant IN 10 mg n = 12
Value	44.25 (122)

Population analysed: The analysis population refers to all participants who were dosed and had at least 1 of the PK parameters of primary interest.

Primary outcome: AUCinf of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN

Measure	Zavegepant IN 10 mg n = 10
Value	53.53 (128)

Population analysed: The analysis population refers to all participants who were dosed and had at least 1 of the PK parameters of primary interest.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 up to maximum of 35 days post single dose administration. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Zavegepant IN 10 mg	0 of 12 (0%)	4 of 12 (33.3%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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

1 site 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 in people with Healthy, run by Pfizer at 1 site in China.

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 3 inclusion and 17 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 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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?

Yes. Results are posted in the registry (first posted 6 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Cmax of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN (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). The study lists 3 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 NCT05960032.

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 6 Jan 2025.