Trial Outcomes & Findings for A Study to Learn About the Study Medicine Called Zavegepant in Healthy Chinese Adult Participants (NCT NCT05960032)
NCT ID: NCT05960032
Last Updated: 2025-01-06
Results Overview
Maximum plasma concentration (Cmax) was measured.
COMPLETED
PHASE1
13 participants
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
2025-01-06
Participant Flow
A total of 13 participants were enrolled and 12 participants received 1 dose of study intervention, and all 12 participants completed the study.
Participant milestones
| Measure |
Zavegepant IN 10 mg
Zavegepant 10 mg was administered intranasally (IN) on Day 1.
|
|---|---|
|
TREATMENT
STARTED
|
12
|
|
TREATMENT
Received Treatment
|
12
|
|
TREATMENT
COMPLETED
|
12
|
|
TREATMENT
NOT COMPLETED
|
0
|
|
FOLLOW-UP
STARTED
|
12
|
|
FOLLOW-UP
COMPLETED
|
12
|
|
FOLLOW-UP
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Learn About the Study Medicine Called Zavegepant in Healthy Chinese Adult Participants
Baseline characteristics by cohort
| Measure |
Zavegepant IN 10 mg
n=12 Participants
Zavegepant 10 mg was administered intranasally (IN) on Day 1.
|
|---|---|
|
Age, Customized
<18 Years
|
0 Participants
n=99 Participants
|
|
Age, Customized
18-25 Years
|
3 Participants
n=99 Participants
|
|
Age, Customized
26-35 Years
|
6 Participants
n=99 Participants
|
|
Age, Customized
36-45 Years
|
3 Participants
n=99 Participants
|
|
Age, Customized
>45 Years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
12 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
12 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 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 1Population: The analysis population refers to all participants who were dosed and had at least 1 of the PK parameters of primary interest.
Maximum plasma concentration (Cmax) was measured.
Outcome measures
| Measure |
Zavegepant IN 10 mg
n=12 Participants
Zavegepant 10 mg was administered intranasally (IN) on Day 1.
|
|---|---|
|
Cmax of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN
|
20.32 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 114
|
PRIMARY outcome
Timeframe: 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 1Population: The analysis population refers to all participants who were dosed and had at least 1 of the PK parameters of primary interest.
AUClast, area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast), was measured.
Outcome measures
| Measure |
Zavegepant IN 10 mg
n=12 Participants
Zavegepant 10 mg was administered intranasally (IN) on Day 1.
|
|---|---|
|
AUClast of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN
|
44.25 ng*hour/mL
Geometric Coefficient of Variation 122
|
PRIMARY outcome
Timeframe: 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 1Population: The analysis population refers to all participants who were dosed and had at least 1 of the PK parameters of primary interest.
AUCinf, area under the plasma concentration-time curve from time 0 extrapolated to infinite time, was measured.
Outcome measures
| Measure |
Zavegepant IN 10 mg
n=10 Participants
Zavegepant 10 mg was administered intranasally (IN) on Day 1.
|
|---|---|
|
AUCinf of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN
|
53.53 ng*hr/mL
Geometric Coefficient of Variation 128
|
SECONDARY outcome
Timeframe: Day 1 up to maximum of 35 days post single dose administrationPopulation: All participants who took study intervention were included in the safety analysis set.
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.
Outcome measures
| Measure |
Zavegepant IN 10 mg
n=12 Participants
Zavegepant 10 mg was administered intranasally (IN) on Day 1.
|
|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
With all-causality TEAEs
|
4 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
With treatment-related TEAEs
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to maximum of 35 days post single dose administrationPopulation: All participants who took study intervention were included in the safety analysis set.
Outcome measures
| Measure |
Zavegepant IN 10 mg
n=12 Participants
Zavegepant 10 mg was administered intranasally (IN) on Day 1.
|
|---|---|
|
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to maximum of 35 days post single dose administrationPopulation: All participants who took study intervention were included in the safety analysis set.
Outcome measures
| Measure |
Zavegepant IN 10 mg
n=12 Participants
Zavegepant 10 mg was administered intranasally (IN) on Day 1.
|
|---|---|
|
Number of Participants With Clinically Significant Values of Vital Signs
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to maximum of 35 days post single dose administrationPopulation: All participants who took study intervention were included in the safety analysis set.
Outcome measures
| Measure |
Zavegepant IN 10 mg
n=12 Participants
Zavegepant 10 mg was administered intranasally (IN) on Day 1.
|
|---|---|
|
Number of Participants With Clinically Significant Values of 12-lead ECGs
|
0 Participants
|
SECONDARY outcome
Timeframe: 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 1Population: The analysis population refers to all participants who were dosed and had at least 1 of the PK parameters of secondary interest.
Tmax, time to Cmax, was measured.
Outcome measures
| Measure |
Zavegepant IN 10 mg
n=12 Participants
Zavegepant 10 mg was administered intranasally (IN) on Day 1.
|
|---|---|
|
Tmax of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN
|
0.584 hour
Interval 0.333 to 1.0
|
SECONDARY outcome
Timeframe: 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 1Population: The analysis population refers to all participants who were dosed and had at least 1 of the PK parameters of secondary interest.
T1/2, terminal half-life, was measured.
Outcome measures
| Measure |
Zavegepant IN 10 mg
n=10 Participants
Zavegepant 10 mg was administered intranasally (IN) on Day 1.
|
|---|---|
|
t1/2 of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN
|
11.00 hour
Standard Deviation 1.4929
|
SECONDARY outcome
Timeframe: 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 1Population: The analysis population refers to all participants who were dosed and had at least 1 of the PK parameters of secondary interest.
CL/F, apparent clearance, was measured.
Outcome measures
| Measure |
Zavegepant IN 10 mg
n=10 Participants
Zavegepant 10 mg was administered intranasally (IN) on Day 1.
|
|---|---|
|
CL/F of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN
|
186.8 Liter/hr
Geometric Coefficient of Variation 128
|
SECONDARY outcome
Timeframe: 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 1Population: The analysis population refers to all participants who were dosed and had at least 1 of the PK parameters of secondary interest.
Vz/F, apparent volume of distribution, was measured.
Outcome measures
| Measure |
Zavegepant IN 10 mg
n=10 Participants
Zavegepant 10 mg was administered intranasally (IN) on Day 1.
|
|---|---|
|
Vz/F of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN
|
2943 Liter
Geometric Coefficient of Variation 141
|
Adverse Events
Zavegepant IN 10 mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Zavegepant IN 10 mg
n=12 participants at risk
Zavegepant 10 mg was administered intranasally (IN) on Day 1.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal discomfort
|
8.3%
1/12 • Day 1 up to maximum of 35 days post single dose administration
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.3%
1/12 • Day 1 up to maximum of 35 days post single dose administration
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucosal discolouration
|
8.3%
1/12 • Day 1 up to maximum of 35 days post single dose administration
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucosal disorder
|
8.3%
1/12 • Day 1 up to maximum of 35 days post single dose administration
|
|
Skin and subcutaneous tissue disorders
Urticaria papular
|
8.3%
1/12 • Day 1 up to maximum of 35 days post single dose administration
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER