A Study to Learn About the Study Medication, Zavegepant,... | NCT06137703

NCT06137703

ID	Type	Description	Link
C5301003	Other Identifier	Alias Study Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sequence 1	Experimental	Period 1 - Single zavegepant 100mg non-enteric coated soft gel capsule (Treatment A) followed by at least 7 days washout; Period 2 - Two zavegepant 100mg immediate release tablets (Treatment C) followed by at least 7 days washout; Period 3 - Single zavegepant 100mg immediate release tablet (Treatment B) followed by at least 7 days washout; Period 4 - Four zavegepant 25mg enteric coated soft gel capsule (Treatment D).	Drug: Zavegepant 100mg non-enteric coated soft gel capsule Drug: Zavegepant 100mg immediate release tablet Drug: Zavegepant 2 x 100mg immediate release tablets Drug: Zavegepant 4 x 25mg enteric coated soft gel capsule
Sequence 2	Experimental	Period 1 - Two zavegepant 100mg immediate release tablets (Treatment C) followed by at least 7 days washout; Period 2 - Four zavegepant 25mg enteric coated soft gel capsule (Treatment D) followed by at least 7 days washout; Period 3 - Single zavegepant 100mg non-enteric coated soft gel capsule (Treatment A) followed by at least 7 days washout; Period 4 - Single zavegepant 100mg immediate release tablet (Treatment B).	Drug: Zavegepant 100mg non-enteric coated soft gel capsule Drug: Zavegepant 100mg immediate release tablet Drug: Zavegepant 2 x 100mg immediate release tablets Drug: Zavegepant 4 x 25mg enteric coated soft gel capsule
Sequence 3	Experimental	Period 1 - Single zavegepant 100mg immediate release tablet (Treatment B) followed by at least 7 days washout; Period 2 - Single zavegepant 100mg non-enteric coated soft gel capsule (Treatment A) followed by at least 7 days washout; Period 3 - Four zavegepant 25mg enteric coated soft gel capsule (Treatment D) followed by at least 7 days washout; Period 4 - Two zavegepant 100mg immediate release tablets (Treatment C).

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Zavegepant 100mg non-enteric coated soft gel capsule	Drug	Zavegepant (PF-07930207/BHV3500) 100mg non-enteric coated soft gel capsule	Sequence 1 Sequence 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of Zavegepant	AUCinf was calculated as AUClast+(Clast/kel), where AUClast is the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. AUClast was calculated using Linear/Log trapezoidal method.	Pre-dose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post dose
Maximum Observed Concentration (Cmax) of Zavegepant	Cmax was observed directly from data.	Pre-dose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post dose
AUClast of Zavegepant	AUClast was calculated using linear/log trapezoidal method.	Pre-dose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post dose

Secondary Outcomes

Measure	Description	Time Frame
Time to Reach Cmax (Tmax) of Zavegepant	Tmax was observed directly from data as time of first occurrence.	Pre-dose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post dose
Terminal Phase Half-Life (t1/2) of Zavegepant

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants must provide Informed Consent Form (ICF) obtained prior to the conduct of any study activities.
Healthy Male or female participants at least 18 and less than 56 years of age,
Participants must be Non-smokers and not have used any nicotine-containing products for 3 months prior to screening.
Body Mass Index (BMI) >18.5 and <30.0kg/m2 and body weight ≥ 50.0kg for males and ≥ 45.0kg for females.
All females participants must not be breastfeeding and have a negative urine pregnancy test at Screening.
Females of childbearing potential must be willing to use acceptable contraceptive methods throughout the study and for 30 days after the last study drug administration.
Male participants with a female partner of childbearing potential must be willing to use acceptable contraceptive methods from the first study drug administration until at least 90 days after the last study drug administration.

Exclusion Criteria:

Current diagnosis of viral hepatitis or a history of liver disease.
Any history of seizure disorder (e.g., epilepsy) other than a single childhood febrile seizure.
Current or recent (within 3 months of the first study drug administration) gastrointestinal disease that may interfere with drug absorption.
Prior gastrointestinal surgery that interferes with absorption and motility (e.g., gastric bypass, duodenectomy or gastric banding).
History of drug or alcohol abuse.
History of anaphylaxis, a documented hypersensitivity reaction, or a clinically significant reaction to any drug or to any of the excipient supporting the zavegepant formulations.
Donation of plasma within 7 days prior to dosing, or donation or loss of blood (excluding volume drawn at Screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to dosing.
Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the dosing, extended to 90 days for biological products.
Inability or difficulty to swallow tablets or capsules.
Subjects with any clinically significant abnormality or significant abnormal laboratory test results found during medical screening or Day-1. Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody during screening.
Inadequate renal function - estimated glomerular filtration rate (eGFR) according to the Modification of Diet in Renal Disease (MDRD) study equation ≤ 60 mL/min/1.73 m2 at Screening.
Any of the following laboratory parameters greater than the upper limit of normal (ULN) values at Screening or Baseline (Day -1): alkaline phosphatase (ALP) aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, direct bilirubin, and indirect bilirubin, and alkaline phosphatase.
Any clinically significant abnormalities on 12-lead ECG or blood pressure (BP) at Screening or Baseline (Day -1) visits.
Any clinically significant abnormal haematological laboratory test values at Screening or Baseline (Day -1) visits.
Positive test for COVID-19 performed on Day -1 of each period.

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Syneos Health Clinical Research Services, Llc		Miami	Florida	33136	United States

References Module

Label	URL
To obtain contact information for a study center near you, click here.	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Sequence DBCA	Participants were assigned to Sequence DBCA, and received a single dose of study intervention on Day 1 of each period per the sequence. There was a washout period of at least 7 days between doses. A=1×100-mg zavegepant non-enteric coated soft gelatin capsule (SGC) administered under fasting condition. B=1×100-mg zavegepant immediate release (IR) tablet + dodecylmaltoside (DDM) dosage form administered under fasting condition. C=1×200-mg zavegepant IR tablet (total dose of 200 mg) + DDM dosage form administered under fasting condition. D=4×25-mg zavegepant enteric coated SGC (total dose of 100 mg) administered under fasting condition.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 16, 2022	Dec 4, 2023

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

t1/2 was calculated as Log e(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

Included all participants who received at least 1 dose of any study intervention.

Arm/Group Information

ID	Title	Description
BG000	All Participants	Participants were assigned to 1 of the 4 sequences, and each sequence consisted of 4 periods. The 4 sequences were ACBD, CDAB, BADC, and DBCA. There was a washout period of at least 7 days between doses. A=1×100-mg zavegepant non-enteric coated SGC administered under fasting condition. B=1×100-mg zavegepant IR tablet + DDM dosage form administered under fasting condition. C=1×200-mg zavegepant IR tablet (total dose of 200 mg) + DDM dosage form administered under fasting condition. D=4×25-mg zavegepant enteric coated SGC (total dose of 100 mg) administered under fasting condition.

Units	Counts
Participants	BG00052

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Median

Full Range

Years

Title

Denominators

Categories

18-65 years of age

Title	Measurements
	BG00037.0(22 to 48)

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00019
Male	BG00033

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00051
Not Hispanic or Latino	BG0001

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian	BG0000
Asian	BG0000

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of Zavegepant

AUCinf was calculated as AUClast+(Clast*/kel), where AUClast is the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast* is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. AUClast was calculated using Linear/Log trapezoidal method.

Included all participants who received at least 1 dose of zavegepant, and for whom the pharmacokinetic (PK) profile had been adequately characterized.

Posted

Geometric Mean

Geometric Coefficient of Variation

Hours*nanograms per milliliter (h*ng/mL)

Pre-dose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post dose

ID	Title	Description
OG000	Treatment A: Zavegepant 100 mg SGC	Participants received a single dose of one 100-mg zavegepant non-enteric coated SGC administered under fasting condition on Day 1 of the period assigned.
OG001	Treatment B: Zavegepant 100 mg IR+DDM	Participants received a single dose of one 100-mg zavegepant IR tablet + DDM dosage form under fasting condition on Day 1 of the period assigned.
OG002	Treatment C: Zavegepant 200 mg IR+DDM	Participants received a single dose of one 200-mg zavegepant IR tablet + DDM dosage form administered under fasting condition on Day 1 of the period assigned.
OG003	Treatment D: Zavegepant 4*25 mg SGC	Participants received a single dose of four 25-mg zavegepant (total dose of 100 mg) enteric coated SGCs administered under fasting condition on Day 1 of the period assigned.

Units	Counts
Participants	OG00048 OG00147 OG00247 OG003

Title

Denominators

Categories

Title	Measurements
	OG00083.65± 52 OG001102.5± 66 OG002184.4± 73 OG003

Primary

Maximum Observed Concentration (Cmax) of Zavegepant

Cmax was observed directly from data.

Included all participants who received at least 1 dose of zavegepant, and for whom the PK profile had been adequately characterized.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

Pre-dose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post dose

ID	Title	Description
OG000	Treatment A: Zavegepant 100 mg SGC	Participants received a signle dose of one 100-mg zavegepant non-enteric coated SGC administered under fasting condition on Day 1 of the period assigned.
OG001	Treatment B: Zavegepant 100 mg IR+DDM	Participants received a single dose of one 100-mg zavegepant IR tablet + DDM dosage form under fasting condition on Day 1 of the period assigned.
OG002	Treatment C: Zavegepant 200 mg IR+DDM	Participants received a single dose of one 200-mg zavegepant IR tablet + DDM dosage form administered under fasting condition on Day 1 of the period assigned.
OG003	Treatment D: Zavegepant 4*25 mg SGC

Primary

AUClast of Zavegepant

AUClast was calculated using linear/log trapezoidal method.

Included all participants who received at least 1 dose of zavegepant, and for whom the PK profile had been adequately characterized.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ng/mL

Pre-dose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post dose

ID	Title	Description
OG000	Treatment A: Zavegepant 100 mg SGC	Participants received a signle dose of one 100-mg zavegepant non-enteric coated SGC administered under fasting condition on Day 1 of the period assigned.
OG001	Treatment B: Zavegepant 100 mg IR+DDM	Participants received a single dose of one 100-mg zavegepant IR tablet + DDM dosage form under fasting condition on Day 1 of the period assigned.
OG002	Treatment C: Zavegepant 200 mg IR+DDM	Participants received a single dose of one 200-mg zavegepant IR tablet + DDM dosage form administered under fasting condition on Day 1 of the period assigned.
OG003	Treatment D: Zavegepant 4*25 mg SGC

Secondary

Time to Reach Cmax (Tmax) of Zavegepant

Tmax was observed directly from data as time of first occurrence.

Included all participants who received at least 1 dose of zavegepant, and for whom the PK profile had been adequately characterized.

Posted

Median

Full Range

Hours

Pre-dose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post dose

ID	Title	Description
OG000	Treatment A: Zavegepant 100 mg SGC	Participants received a signle dose of one 100-mg zavegepant non-enteric coated SGC administered under fasting condition on Day 1 of the period assigned.
OG001	Treatment B: Zavegepant 100 mg IR+DDM	Participants received a single dose of one 100-mg zavegepant IR tablet + DDM dosage form under fasting condition on Day 1 of the period assigned.
OG002	Treatment C: Zavegepant 200 mg IR+DDM	Participants received a single dose of one 200-mg zavegepant IR tablet + DDM dosage form administered under fasting condition on Day 1 of the period assigned.
OG003	Treatment D: Zavegepant 4*25 mg SGC

Secondary

Terminal Phase Half-Life (t1/2) of Zavegepant

t1/2 was calculated as Log e(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

Included all participants who received at least 1 dose of zavegepant, and for whom the PK profile had been adequately characterized.

Posted

Mean

Standard Deviation

Hours

Pre-dose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post dose

ID	Title	Description
OG000	Treatment A: Zavegepant 100 mg SGC	Participants received a signle dose of one 100-mg zavegepant non-enteric coated SGC administered under fasting condition on Day 1 of the period assigned.
OG001	Treatment B: Zavegepant 100 mg IR+DDM	Participants received a single dose of one 100-mg zavegepant IR tablet + DDM dosage form under fasting condition on Day 1 of the period assigned.
OG002	Treatment C: Zavegepant 200 mg IR+DDM	Participants received a single dose of one 200-mg zavegepant IR tablet + DDM dosage form administered under fasting condition on Day 1 of the period assigned.
OG003

Secondary

Apparent Clearance (CL/F) of Zavegepant From Plasma

CL/F was calculated as dose/AUCinf. AUCinf was calucalted as AUClast+(Clast*/kel), where Clast* is the predicted plasma concentration at the last quantifiable time point estimated, and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. AUClast was calculated using linear/log trapezoidal method.

Included all participants who received at least 1 dose of zavegepant, and for whom the PK profile had been adequately characterized.

Posted

Geometric Mean

Geometric Coefficient of Variation

liters per hour (L/h)

Pre-dose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose

ID	Title	Description
OG000	Treatment A: Zavegepant 100 mg SGC	Participants received a signle dose of one 100-mg zavegepant non-enteric coated SGC administered under fasting condition on Day 1 of the period assigned.
OG001	Treatment B: Zavegepant 100 mg IR+DDM	Participants received a single dose of one 100-mg zavegepant IR tablet + DDM dosage form under fasting condition on Day 1 of the period assigned.
OG002	Treatment C: Zavegepant 200 mg IR+DDM	Participants received a single dose of one 200-mg zavegepant IR tablet + DDM dosage form administered under fasting condition on Day 1 of the period assigned.

Secondary

Apparent Volume of Distribution (Vz/F) of Zavegepant

Vz/F was calculated by Dose/(AUCinf×kel). AUCinf was calculated by AUClast+(Clast*/kel), where Clast* is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. AUClast was calculated using the linear/log trapezoidal method.

Included all participants who received at least 1 dose of zavegepant, and for whom the PK profile had been adequately characterized.

Posted

Geometric Mean

Geometric Coefficient of Variation

Pre-dose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post dose

ID	Title	Description
OG000	Treatment A: Zavegepant 100 mg SGC	Participants received a single dose of one 100-mg zavegepant non-enteric coated SGC administered under fasting condition on Day 1 of the period assigned.
OG001	Treatment B: Zavegepant 100 mg IR+DDM	Participants received a single dose of one 100-mg zavegepant IR tablet + DDM dosage form under fasting condition on Day 1 of the period assigned.
OG002	Treatment C: Zavegepant 200 mg IR+DDM

Secondary

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Adverse evetn (AE)=any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. TEAEs=AEs between first dose of study treatment and up to the end of study participation that were absent before treatment or that worsened relative to pretreatment state. A serious TEAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. SAEs were adjudicated according to the investigator's assessment. Treatment-related was classified based on medical judgement. Severe=Incapacitating with inability to carry out usual activities or significantly affects clinical status, and requires specific action and/or medical attention.

Included all participants who received at least 1 dose of any study intervention.

Posted

Count of Participants

Participants

Baseline up to study exit (approximately 6.5 weeks)

ID	Title	Description
OG000	Treatment A: Zavegepant 100 mg SGC	Participants received a signle dose of one 100-mg zavegepant non-enteric coated SGC administered under fasting condition on Day 1 of the period assigned.
OG001	Treatment B: Zavegepant 100 mg IR+DDM

Secondary

Number of Participants With Clinically Significant Laboratory Abnormalities

Clinically significant laboratory abnormalities were identified as Grade 3 to 4 laboratory test results graded according to numeric laboratory test criteria in the latest version of Common Technical Criteria for Adverse Events (CTCAE) if available, otherwise according to the latest version of Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version. Clinically significant laboratory abnormalities with occurrence in at least 1 participant are reported for this outcome measure. Baseline was defined as the last results (scheduled or unscheduled) obtained prior to the first drug administration.

Included all participants who received at least 1 dose of any study intervention.

Posted

Count of Participants

Participants

Baseline up to study exit (approximately 6.5 weeks)

ID	Title	Description
OG000	Treatment A: Zavegepant 100 mg SGC	Participants received a single dose of one 100-mg zavegepant non-enteric coated SGC administered under fasting condition on Day 1 of the period assigned.
OG001	Treatment B: Zavegepant 100 mg IR+DDM	Participants received a single dose of one 100-mg zavegepant IR tablet + DDM dosage form under fasting condition on Day 1 of the period assigned.
OG002

Secondary

Blood Pressure on Day -1 and Day 1 of Each Period

Blood pressure was measured after the participants had been resting for at least 5 minutes in a seated position. Normal range for systolic blood pressure (SBP)=90-140 mm Hg; normal range for diastolic blood pressure (DBP)=50-90 mm Hg.

Safety analysis set included all participants who received at least 1 dose of any study intervention. Number of Participants Analyzed represents the total number of participants in the safety analysis set. Number Analyzed in each row represents the number of participants with observations at each time point.

Posted

Median

Full Range

millimeter of mercury (mm Hg)

Day -1, pre-dose and 2 hours post dose on Day 1 of each period

ID	Title	Description
OG000	Treatment A: Zavegepant 100 mg SGC	Participants received a signle dose of one 100-mg zavegepant non-enteric coated SGC administered under fasting condition on Day 1 of the period assigned.
OG001	Treatment B: Zavegepant 100 mg IR+DDM	Participants received a single dose of one 100-mg zavegepant IR tablet + DDM dosage form under fasting condition on Day 1 of the period assigned.
OG002	Treatment C: Zavegepant 200 mg IR+DDM	Participants received a single dose of one 200-mg zavegepant IR tablet + DDM dosage form administered under fasting condition on Day 1 of the period assigned.

Secondary

Blood Pressure at Screening and Study Exit

Blood pressure was measured after the participants had been resting for at least 5 minutes in a seated position. Normal range for SBP=90-140 mm Hg; normal range for DBP=50-90 mm Hg.

Posted

Median

Full Range

mm Hg

Screening and study exit

ID	Title	Description
OG000	All Participants	Participants were assigned to 1 of the 4 sequences, and each sequence consisted of 4 periods. The 4 sequences were ACBD, CDAB, BADC, and DBCA. There was a washout period of at least 7 days between doses. A=1×100-mg zavegepant non-enteric coated SGC administered under fasting condition. B=1×100-mg zavegepant IR tablet + DDM dosage form administered under fasting condition. C=1×200-mg zavegepant IR tablet (total dose of 200 mg) + DDM dosage form administered under fasting condition. D=4×25-mg zavegepant enteric coated SGC (total dose of 100 mg) administered under fasting condition.

Units	Counts
Participants

Secondary

Heart Rate (HR) on Day -1 and Day 1 of Each Period

HR was measured after the participants had been resting for at least 5 minutes in a seated position. Normal range for heart rate=50-100 beats/min.

Posted

Median

Full Range

Beats per minute (beats/min)

Day -1, pre-dose and 2 hours post dose on Day 1 of each period

ID	Title	Description
OG000	Treatment A: Zavegepant 100 mg SGC	Participants received a signle dose of one 100-mg zavegepant non-enteric coated SGC administered under fasting condition on Day 1 of the period assigned.
OG001	Treatment B: Zavegepant 100 mg IR+DDM	Participants received a single dose of one 100-mg zavegepant IR tablet + DDM dosage form under fasting condition on Day 1 of the period assigned.
OG002	Treatment C: Zavegepant 200 mg IR+DDM	Participants received a single dose of one 200-mg zavegepant IR tablet + DDM dosage form administered under fasting condition on Day 1 of the period assigned.

Secondary

HR at Screening and Study Exit

HR was measured after the participants had been resting for at least 5 minutes in a seated position. Normal range for heart rate=50-100 beats/min.

Posted

Median

Full Range

beats/min

Screening and study exit

ID	Title	Description
OG000	All Participants	Participants were assigned to 1 of the 4 sequences, and each sequence consisted of 4 periods. The 4 sequences were ACBD, CDAB, BADC, and DBCA. There was a washout period of at least 7 days between doses. A=1×100-mg zavegepant non-enteric coated SGC administered under fasting condition. B=1×100-mg zavegepant IR tablet + DDM dosage form administered under fasting condition. C=1×200-mg zavegepant IR tablet (total dose of 200 mg) + DDM dosage form administered under fasting condition. D=4×25-mg zavegepant enteric coated SGC (total dose of 100 mg) administered under fasting condition.

Units	Counts
Participants

Secondary

Respiratory Rate (RR) on Day -1 of Each Period

RR was measured after the participants had been resting for at least 5 minutes in a sitting position. Normal range for RR=8-20 breaths/min.

Posted

Median

Full Range

Breaths per minute (breaths/min)

Day -1 of each period

ID	Title	Description
OG000	Treatment A: Zavegepant 100 mg SGC	Participants received a signle dose of one 100-mg zavegepant non-enteric coated SGC administered under fasting condition on Day 1 of the period assigned.
OG001	Treatment B: Zavegepant 100 mg IR+DDM	Participants received a single dose of one 100-mg zavegepant IR tablet + DDM dosage form under fasting condition on Day 1 of the period assigned.
OG002	Treatment C: Zavegepant 200 mg IR+DDM	Participants received a single dose of one 200-mg zavegepant IR tablet + DDM dosage form administered under fasting condition on Day 1 of the period assigned.

Secondary

RR at Screening and Study Exit

RR was measured after the participants had been resting for at least 5 minutes in a sitting position. Normal range for RR=8-20 breaths/min.

Posted

Median

Full Range

breaths/min

Screening and study exit

ID	Title	Description
OG000	All Participants	Participants were assigned to 1 of the 4 sequences, and each sequence consisted of 4 periods. The 4 sequences were ACBD, CDAB, BADC, and DBCA. There was a washout period of at least 7 days between doses. A=1×100-mg zavegepant non-enteric coated SGC administered under fasting condition. B=1×100-mg zavegepant IR tablet + DDM dosage form administered under fasting condition. C=1×200-mg zavegepant IR tablet (total dose of 200 mg) + DDM dosage form administered under fasting condition. D=4×25-mg zavegepant enteric coated SGC (total dose of 100 mg) administered under fasting condition.

Units	Counts
Participants

Secondary

Temperature on Day -1 of Each Period

Temperature was measured after the participants had been resting for at least 5 minutes in a seated position. Normal range for temperature=35.8-37.6 ℃.

Safety analysis set included all participants who received at least 1 dose of any study intervention. Number of Participants Analyzed represents the total number of participants in the safety analysis set who had at least 1 observation of temperature on Day -1.

Posted

Median

Full Range

Degree Celsius (℃)

Day -1 of each period

ID	Title	Description
OG000	Treatment A: Zavegepant 100 mg SGC	Participants received a signle dose of one 100-mg zavegepant non-enteric coated SGC administered under fasting condition on Day 1 of the period assigned.
OG001	Treatment B: Zavegepant 100 mg IR+DDM	Participants received a single dose of one 100-mg zavegepant IR tablet + DDM dosage form under fasting condition on Day 1 of the period assigned.
OG002	Treatment C: Zavegepant 200 mg IR+DDM	Participants received a single dose of one 200-mg zavegepant IR tablet + DDM dosage form administered under fasting condition on Day 1 of the period assigned.

Secondary

Temperature at Screening and Study Exit

Temperature was measured after the participants had been resting for at least 5 minutes in a seated position. Normal range for temperature=35.8-37.6 ℃.

Included all participants who received at least 1 dose of any study intervention.

Posted

Median

Full Range

℃

Screening and study exit

ID	Title	Description
OG000	All Participants	Participants were assigned to 1 of the 4 sequences, and each sequence consisted of 4 periods. The 4 sequences were ACBD, CDAB, BADC, and DBCA. There was a washout period of at least 7 days between doses. A=1×100-mg zavegepant non-enteric coated SGC administered under fasting condition. B=1×100-mg zavegepant IR tablet + DDM dosage form administered under fasting condition. C=1×200-mg zavegepant IR tablet (total dose of 200 mg) + DDM dosage form administered under fasting condition. D=4×25-mg zavegepant enteric coated SGC (total dose of 100 mg) administered under fasting condition.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG)

ECG was measured after the participants had been resting for at least 5 minutes in a seated position.

Included all participants who received at least 1 dose of any study intervention.

Posted

Count of Participants

Participants

Screening up to study exit (approximately 6.5 weeks)

ID	Title	Description
OG000	All Participants	Participants were assigned to 1 of the 4 sequences, and each sequence consisted of 4 periods. The 4 sequences were ACBD, CDAB, BADC, and DBCA. There was a washout period of at least 7 days between doses. A=1×100-mg zavegepant non-enteric coated SGC administered under fasting condition. B=1×100-mg zavegepant IR tablet + DDM dosage form administered under fasting condition. C=1×200-mg zavegepant IR tablet (total dose of 200 mg) + DDM dosage form administered under fasting condition. D=4×25-mg zavegepant enteric coated SGC (total dose of 100 mg) administered under fasting condition.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Treatment A: Zavegepant 100 mg SGC	Participants received a signle dose of one 100-mg zavegepant non-enteric coated SGC administered under fasting condition on Day 1 of the period assigned.	51	1	51	3	51
EG001	Treatment B: Zavegepant 100 mg IR+DDM	Participants received a single dose of one 100-mg zavegepant IR tablet + DDM dosage form under fasting condition on Day 1 of the period assigned.	51	0	51	2	51
EG002	Treatment C: Zavegepant 200 mg IR+DDM	Participants received a single dose of one 200-mg zavegepant IR tablet + DDM dosage form administered under fasting condition on Day 1 of the period assigned.	50	0	50	4	50
EG003	Treatment D: Zavegepant 4*25 mg SGC	Participants received a single dose of four 25-mg zavegepant (total dose of 100 mg) enteric coated SGCs administered under fasting condition on Day 1 of the period assigned.	50	0	50	3	50

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Abdominal pain	Gastrointestinal disorders	25.0	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk EG0020 affected50 at risk EG0030 affected50 at risk
Pancreatitis acute	Gastrointestinal disorders	25.0	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk EG0020 affected50 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Skin abrasion	Injury, poisoning and procedural complications	25.0	Non-systematic Assessment	EG0001 affected51 at risk EG0010 affected51 at risk EG0022 affected50 at risk EG0031 affected50 at risk
Haemoglobin decreased	Investigations	25.0	Non-systematic Assessment	EG0000 affected51 at risk EG0011 affected51 at risk EG0020 affected50 at risk EG003
Alanine aminotransferase increased	Investigations	25.0	Non-systematic Assessment	EG0001 affected51 at risk EG0010 affected51 at risk EG0020 affected50 at risk EG003
Aspartate aminotransferase increased	Investigations	25.0	Non-systematic Assessment	EG0001 affected51 at risk EG0010 affected51 at risk EG0020 affected50 at risk EG003
Blood bilirubin increased	Investigations	25.0	Non-systematic Assessment	EG0001 affected51 at risk EG0010 affected51 at risk EG0020 affected50 at risk EG003
Lipase increased	Investigations	25.0	Non-systematic Assessment	EG0001 affected51 at risk EG0010 affected51 at risk EG0020 affected50 at risk EG003
White blood cells urine positive	Investigations	25.0	Non-systematic Assessment	EG0001 affected51 at risk EG0010 affected51 at risk EG0020 affected50 at risk EG003
Dizziness	Nervous system disorders	25.0	Non-systematic Assessment	EG0000 affected51 at risk EG0011 affected51 at risk EG0021 affected50 at risk EG003
Presyncope	Nervous system disorders	25.0	Non-systematic Assessment	EG0000 affected51 at risk EG0011 affected51 at risk EG0020 affected50 at risk EG003
Syncope	Nervous system disorders	25.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected51 at risk EG0020 affected50 at risk EG003
Abdominal pain	Gastrointestinal disorders	25.0	Non-systematic Assessment	EG0001 affected51 at risk EG0010 affected51 at risk EG0020 affected50 at risk EG003
Vomiting	Gastrointestinal disorders	25.0	Non-systematic Assessment	EG0001 affected51 at risk EG0010 affected51 at risk EG0020 affected50 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	25.0	Non-systematic Assessment	EG0001 affected51 at risk EG0010 affected51 at risk EG0020 affected50 at risk EG003
Nausea	Gastrointestinal disorders	25.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected51 at risk EG0021 affected50 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	25.0	Non-systematic Assessment	EG0001 affected51 at risk EG0010 affected51 at risk EG0020 affected50 at risk EG003
Urinary tract infection	Infections and infestations	25.0	Non-systematic Assessment	EG0001 affected51 at risk EG0010 affected51 at risk EG0020 affected50 at risk EG003

Participants received a single dose of one 200-mg zavegepant IR tablet + DDM dosage form administered under fasting condition on Day 1 of the period assigned.

Participants received a single dose of one 100-mg zavegepant IR tablet + DDM dosage form under fasting condition on Day 1 of the period assigned.