Phase 1
Completed N=12
A Study to Learn About the Study Medicine Called Zavegepant in Healthy Chinese Adult Participants
Healthy
Source: ClinicalTrials.gov NCT05960032 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcomePrimary: Cmax of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN — 20.32 nanogram per milliliter (ng/mL)
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.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN |
20.32 | — |
| PRIMARY AUClast of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN |
44.25 | — |
| PRIMARY AUCinf of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN |
53.53 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
4; 3 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) |
1 | — |
| SECONDARY Number of Participants With Clinically Significant Values of Vital Signs |
— | — |
| SECONDARY Number of Participants With Clinically Significant Values of 12-lead ECGs |
— | — |
| SECONDARY Tmax of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN |
0.584 | — |
| SECONDARY t1/2 of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN |
11.00 | — |
| SECONDARY CL/F of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN |
186.8 | — |
| SECONDARY Vz/F of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN |
2943 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05960032). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.