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Completed

NCT Number: NCT05948085

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

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.

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Key information

Conditions

Healthy Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit - New Haven

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female ≥18 years of age and older at the time of signing the informed consent document (ICD).
  • Male and female participants who are overtly healthy as determined by medical evaluation.
  • Body Mass Index (BMI) 16.0-32.0 kg/m2 and body weight ≥45.0 kg (99 lb).
  • 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

  • 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).
  • 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).
  • Significant history of seizure disorder other than a single childhood febrile seizure (eg, epilepsy) or 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.
  • 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 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.
  • Any reason that, in the opinion of the PI, would prevent the participant from participating in the study.

Treatment and study plan

Zavegepant 10 mg IN

Drug

All participants will receive zavegepant 10 mg IN spray in period 1 and a butterscotch candy + zavegepant 10 mg IN spray in period 2

Primary outcomes

  1. Plasma Concentration of Zavegepant at 30 Minutes Post-dose on Day 1 of Period 1- Tasso Device Versus (vs.) Standard Venous Phlebotomy

    Time frame: 30 minutes post-dose on Day 1 of Period 1

    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).

  2. Plasma Concentration of Zavegepant at 1 Hour Post-dose on Day 1 of Period 1- Tasso Device vs. Standard Venous Phlebotomy

    Time frame: 1-hour post-dose on Day 1 of Period 1

    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).

  3. Plasma Concentration of Zavegepant at 2 Hours Post-dose on Day 1 of Period 1- Tasso Device vs. Standard Venous Phlebotomy

    Time frame: 2-hours post-dose on Day 1 of Period 1

    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. Plasma Concentration of Zavegepant at 4 Hours Post-dose on Day 1 of Period 1- Tasso Device vs. Standard Venous Phlebotomy

    Time frame: 4-hours post-dose on Day 1 of Period 1

    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).

  5. Plasma Concentration of Zavegepant at 8 Hours Post-dose on Day 1 of Period 1- Tasso Device vs. Standard Venous Phlebotomy

    Time frame: 8-hours post-dose on Day 1 of Period 1

    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).

  6. Plasma Concentration of Zavegepant at 12 Hours Post-dose on Day 1 of Period 1- Tasso Device vs. Standard Venous Phlebotomy

    Time frame: 12-hours post-dose on Day 1 of Period 1

    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).

  7. Area Under the Plasma Concentration-Time Profile From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of Zavegepant: - Tasso Device vs. Standard Venous Phlebotomy

    Time frame: 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

    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. 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

    Time frame: 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

    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).

  9. Maximum Plasma Concentration (Cmax) of Zavegepant - Tasso Device vs. Standard Venous Phlebotomy

    Time frame: 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

    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).

  10. Time for Cmax (Tmax) of Zavegepant - Tasso Device vs. Standard Venous Phlebotomy

    Time frame: 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

    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).

  11. Terminal Half-Life (t1/2) of Zavegepant - Tasso Device vs. Standard Venous Phlebotomy

    Time frame: 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

    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).

  12. Apparent Clearance (CL/F) of Zavegepant - Tasso Device vs. Standard Venous Phlebotomy

    Time frame: 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

    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).

  13. Apparent Volume of Distribution (Vz/F) of Zavegepant - Tasso Device vs. Standard Venous Phlebotomy

    Time frame: 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

    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).

Secondary outcomes

  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Time frame: From Day 1 of dosing up to 35 days post last dose of study drug (up to 37 days)

    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.

  2. Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)

    Time frame: During study treatment (Day 1 of Period 1 and 2, 2 days)

    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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 17, 2023
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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