Skip to main content
OpenTrials
Completed

NCT Number: NCT05960032

A Study to Learn About the Study Medicine Called Zavegepant 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Huashan Hospital,Fudan University

Shanghai, Shanghai Municipality, 201107, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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).

Exclusion criteria

  • 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).
  • 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.

Treatment and study plan

Zavegepant

Drug

Participants receiving single dose of Zavegepant 10 mg

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

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

    Time frame: Day 1 up to maximum of 35 days post single dose administration

    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.

  2. 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

  3. Number of Participants With Clinically Significant Values of Vital Signs

    Time frame: Day 1 up to maximum of 35 days post single dose administration

  4. 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

  5. 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

    Tmax, time to Cmax, was measured.

  6. 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

    T1/2, terminal half-life, was measured.

  7. 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

    CL/F, apparent clearance, was measured.

  8. 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

    Vz/F, apparent volume of distribution, was measured.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 25, 2023
Registry last updated
Jan 6, 2025

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.

Published trials that share one or more normalized conditions with this study.