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NCT05948085 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Healthy, sponsored by Pfizer.

Completed
Registry status
Phase 1
Development phase
14
Enrollment target
1
Study location

NCT05948085 is a Phase 1 study of Healthy that has completed, run by Pfizer. The registered enrollment target is 14 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05948085, a Phase 1 study of Healthy, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 1
Development phase
14 participants
Enrollment target
1
Study location

Study Summary

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.

Conditions Studied

Healthy

Interventions

  • DRUG Zavegepant 10 mg IN

Study Locations (1)

Connecticut

  • Pfizer Clinical Research Unit - New Haven - New Haven

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2023-07-10
Est. Completion 2023-09-05
Phase Phase 1

Sponsor

Pfizer

1,845 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05948085

The ClinicalTrials.gov registry entry for NCT05948085 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower). The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which Zavegepant 10 mg IN is the first listed.

NCT05948085 reports 1 study location spanning 1 distinct geographic area - top geographies include Connecticut.

Frequently Asked Questions

What is clinical trial NCT05948085 about?

NCT05948085 is a clinical study titled "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 ...

What is the current status of trial NCT05948085?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2023-07-10. Estimated completion is 2023-09-05.

What conditions does trial NCT05948085 study?

This clinical trial studies the following conditions: Healthy.

What interventions are being tested in trial NCT05948085?

The interventions under investigation include: Zavegepant 10 mg IN (DRUG).

Who is sponsoring clinical trial NCT05948085?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05948085 being conducted?

This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.