A Study to Compare Zavegepant Concentration Using Samples Collected From the Vein Versus Patient-Centric Microsampling

A Pharmacokinetic Study of Zavegepant Intranasal in Healthy Adults Comparing Conventional Venous Blood Sampling With Patient-Centric Sampling

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Zavegepant 10 mg IN

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Pfizer Clinical Research Unit - New Haven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Male or female ≥18 years of age and older at the time of signing the informed consent document (ICD).
2. Male and female participants who are overtly healthy as determined by medical evaluation.
3. Body Mass Index (BMI) 16.0-32.0 kg/m2 and body weight ≥45.0 kg (99 lb).
4. Females must not be breastfeeding or lactating and must have a negative urine or serum pregnancy test (minimum sensitivity 25 international units per liter [IU/L] or equivalent units of human chorionic gonadotropin [HCG]) at screening. Woman/women of childbearing potential (WOCBP) must have negative urine or serum pregnancy test at admission.

Exclusion Criteria:

1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
2. 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, localized infection or ulceration, congestion, polyposis, rhinorrhea, nasal surgery within the previous 6 months, or nasal trauma).
3. Significant history of seizure disorder other than a single childhood febrile seizure (eg, epilepsy) or history of gallstone or cholecystectomy.
4. 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.
5. Use of organic anion transporting polypeptide 1B3 (OATP1B3) inhibitors within 14 days or 5 half-lives, whichever is longer, before first dosing.
6. 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.
7. 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 PI.
8. 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.
9. Any reason that, in the opinion of the PI, would prevent the participant from participating in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Zavegepant 10 mg Intranasal (IN); All participants will receive zavegepant 10 mg IN spray in period 1 and a butterscotch candy + zavegepant 10 mg IN spray in period 2	Drug: Zavegepant 10 mg IN; All participants will receive zavegepant 10 mg IN spray in period 1 and a butterscotch candy + zavegepant 10 mg IN spray in period 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
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

Secondary Outcome Measures

Outcome Measure	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.	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)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2023
• Primary Completion (Actual): September 5, 2023
• Study Completion (Actual): September 5, 2023

Study Registration Dates

• First Submitted: July 7, 2023
• First Submitted That Met QC Criteria: July 7, 2023
• First Posted (Actual): July 17, 2023

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Migraine; Healthy Volunteers; Zavegepant; Tasso
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: C5301022; NCT05948085 (Registry Identifier: ClinicalTrials.gov)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No