Biological AvailabilityPhase 1NCT06137703
A Study to Learn About the Study Medication, Zavegepant, in Healthy Volunteers
A Phase 1 study testing Zavegepant 100mg non-enteric coated soft gel capsule, Zavegepant 100mg immediate release tablet and Zavegepant 2 x 100mg immediate release tablets in people with Biological Availability, run by Pfizer at 1 site in United States.
Trial summary
This trial is designed to compare the rate and extent of absorption of four different formulations of zavegepant. 52 healthy male and female volunteers will receive a single dose of each formulation at least 7 days apart over a period of about 7 weeks and the amount of drug in their blood will be assessed over the 24… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Biological Availability
- What is being tested?
- Zavegepant 100mg non-enteric coated soft gel capsule, Zavegepant 100mg immediate release tablet and Zavegepant 2 x 100mg immediate release tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2022to 7 Dec 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Syneos Health Clinical Research Services, Llc
Miami, Florida, 33136
About this study
Official title: A PHASE 1, OPEN-LABEL, RANDOMIZED, 4-PERIOD, 4-WAY CROSSOVER, RELATIVE BIOAVAILABILITY STUDY OF ZAVEGEPANT (BHV-3500) ORAL FORMULATIONS UNDER FASTING CONDITIONS
This trial is designed to compare the rate and extent of absorption of four different formulations of zavegepant. 52 healthy male and female volunteers will receive a single dose of each formulation at least 7 days apart over a period of about 7 weeks and the amount of drug in their blood will be assessed over the 24 hour period after each dose.
Read the detailed description
This is a Phase 1, single centre, open-label, single dose, 4-period, crossover study designed to compare the pharmacokinetics (PK) of zavegepant from three Test products and a Reference product (treatment D).
52 male and female healthy volunteers will be randomly assigned to one of 4 treatment sequences: ACBD, CDAB, BADC, and DBCA.
In each period, subjects will receive one of the following: Treatment A, B, C, or D on Day 1, followed by 24 hours of PK and safety assessments. On Day 2 subjects will be discharged from the clinical site and instructed to return after at least a 7 day washout time has passed for subsequent periods of treatment.
The study will include a screening visit from Day -28 to Day -2. Eligible subjects will be admitted to the clinical site on Day -1 and will be confined until completion of the assessments on Day 2. There will be a washout period of at least 7 days between doses. Study Exit procedures will be performed after the last assessment on the morning of Day 2 of Period 4. Study Exit procedures will be performed as soon as possible in case of Early Termination.
The total duration of study participation for each subject from Screening through Study Exit is anticipated to be approximately 6.5 weeks.
- Conditions
- Biological Availability
- Being tested
- Zavegepant 100mg non-enteric coated soft gel capsule, Zavegepant 100mg immediate release tablet, Zavegepant 2 x 100mg immediate release tablets, Zavegepant 4 x 25mg enteric coated soft gel capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zavegepant 100mg non-enteric coated soft gel capsuleDrug
Also called Treatment A
Zavegepant (PF-07930207/BHV3500) 100mg non-enteric coated soft gel capsule
Zavegepant 100mg immediate release tabletDrug
Also called Treatment B
Zavegepant (PF-07930207/BHV3500) 100mg dodecylmaltoside dosage form immediate release tablet
Zavegepant 2 x 100mg immediate release tabletsDrug
Also called Treatment C
2 x Zavegepant (PF-07930207/BHV3500) 100mg dodecylmaltoside dosage form immediate release tablets - total dose 200mg
Zavegepant 4 x 25mg enteric coated soft gel capsuleDrug
Also called Treatment D
Zavegepant (PF-07930207/BHV3500) 25 mg enteric coated soft gel capsules - total dose 100mg
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: 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 4 | Experimental | Period 1 - Four zavegepant 25mg enteric coated soft gel capsule (Treatment D) followed by at least 7 days washout; Period 2 - Single zavegepant 100mg immediate release tablet (Treatment B) followed by at least 7 days washout; Period 3 - Two zavegepant 100mg immediate release tablets (Treatment C) followed by at least 7 days washout; Period 4 - Single zavegepant 100mg non-enteric coated soft gel capsule (Treatment A). Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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 (15)
Time to Reach Cmax (Tmax) of Zavegepant
Tmax was observed directly from data as time of first occurrence.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline up to study exit (approximately 6.5 weeks)
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.
Measured: Baseline up to study exit (approximately 6.5 weeks)
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.
Measured: Day -1, pre-dose and 2 hours post dose on Day 1 of each period
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.
Measured: Screening and study exit
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.
Measured: Day -1, pre-dose and 2 hours post dose on Day 1 of each period
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.
Measured: Screening and study exit
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.
Measured: Day -1 of each period
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.
Measured: Screening and study exit
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 ℃.
Measured: Day -1 of each period
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 ℃.
Measured: Screening and study exit
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.
Measured: Screening up to study exit (approximately 6.5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start24 Aug 2022
- Primary completion7 Dec 2022
- Study completion7 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Biological AvailabilityStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, open-label, single dose, 4-period cross-over, comparative bioavailability study in healthy volunteer participants.
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06137703
- Sponsor's protocol ID
- BHV3500-113
- Other IDs
- C5301003
- Status last verified
- Jun 2024
- First submitted
- 14 Nov 2023
- Last updated
- 1 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, OPEN-LABEL, RANDOMIZED, 4-PERIOD, 4-WAY CROSSOVER, RELATIVE BIOAVAILABILITY STUDY OF ZAVEGEPANT (BHV-3500) ORAL FORMULATIONS UNDER FASTING CONDITIONS
- ClinicalTrials.gov ID
- NCT06137703
- Acronym / sponsor ID
- BHV3500-113
- Conditions
- Biological Availability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 24 Aug 2022 (actual)
- Primary completion
- 7 Dec 2022 (actual)
- Study completion
- 7 Dec 2022 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Posted 1 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is designed to compare the rate and extent of absorption of four different formulations of zavegepant. 52 healthy male and female volunteers will receive a single dose of each formulation at least 7 days apart over a period of about 7 weeks and the amount of drug in their blood will be assessed over the 24 hour period after each dose.
Detailed description
This is a Phase 1, single centre, open-label, single dose, 4-period, crossover study designed to compare the pharmacokinetics (PK) of zavegepant from three Test products and a Reference product (treatment D).
52 male and female healthy volunteers will be randomly assigned to one of 4 treatment sequences: ACBD, CDAB, BADC, and DBCA.
In each period, subjects will receive one of the following: Treatment A, B, C, or D on Day 1, followed by 24 hours of PK and safety assessments. On Day 2 subjects will be discharged from the clinical site and instructed to return after at least a 7 day washout time has passed for subsequent periods of treatment.
The study will include a screening visit from Day -28 to Day -2. Eligible subjects will be admitted to the clinical site on Day -1 and will be confined until completion of the assessments on Day 2. There will be a washout period of at least 7 days between doses. Study Exit procedures will be performed after the last assessment on the morning of Day 2 of Period 4. Study Exit procedures will be performed as soon as possible in case of Early Termination.
The total duration of study participation for each subject from Screening through Study Exit is anticipated to be approximately 6.5 weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Randomized, open-label, single dose, 4-period cross-over, comparative bioavailability study in healthy volunteer participants.
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | 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 capsulePeriod 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). |
| Sequence 2 | Experimental | 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 capsulePeriod 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). |
| Sequence 3 | Experimental | 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 capsulePeriod 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). |
| Sequence 4 | Experimental | 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 capsulePeriod 1 - Four zavegepant 25mg enteric coated soft gel capsule (Treatment D) followed by at least 7 days washout; Period 2 - Single zavegepant 100mg immediate release tablet (Treatment B) followed by at least 7 days washout; Period 3 - Two zavegepant 100mg immediate release tablets (Treatment C) followed by at least 7 days washout; Period 4 - Single zavegepant 100mg non-enteric coated soft gel capsule (Treatment A). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zavegepant 100mg non-enteric coated soft gel capsuleAlso: Treatment AZavegepant (PF-07930207/BHV3500) 100mg non-enteric coated soft gel capsule | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| Zavegepant 100mg immediate release tabletAlso: Treatment BZavegepant (PF-07930207/BHV3500) 100mg dodecylmaltoside dosage form immediate release tablet | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| Zavegepant 2 x 100mg immediate release tabletsAlso: Treatment C2 x Zavegepant (PF-07930207/BHV3500) 100mg dodecylmaltoside dosage form immediate release tablets - total dose 200mg | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| Zavegepant 4 x 25mg enteric coated soft gel capsuleAlso: Treatment DZavegepant (PF-07930207/BHV3500) 25 mg enteric coated soft gel capsules - total dose 100mg | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
Primary outcome
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of Zavegepant
Time frame: 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
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.
Maximum Observed Concentration (Cmax) of Zavegepant
Time frame: 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
Cmax was observed directly from data.
AUClast of Zavegepant
Time frame: 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 was calculated using linear/log trapezoidal method.
15 secondary outcomes
Time to Reach Cmax (Tmax) of Zavegepant
Time frame: 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
Time frame: 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
Apparent Clearance (CL/F) of Zavegepant From Plasma
Time frame: 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
Apparent Volume of Distribution (Vz/F) of Zavegepant
Time frame: 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
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Baseline up to study exit (approximately 6.5 weeks)
Number of Participants With Clinically Significant Laboratory Abnormalities
Time frame: Baseline up to study exit (approximately 6.5 weeks)
Blood Pressure on Day -1 and Day 1 of Each Period
Time frame: Day -1, pre-dose and 2 hours post dose on Day 1 of each period
Blood Pressure at Screening and Study Exit
Time frame: Screening and study exit
Heart Rate (HR) on Day -1 and Day 1 of Each Period
Time frame: Day -1, pre-dose and 2 hours post dose on Day 1 of each period
HR at Screening and Study Exit
Time frame: Screening and study exit
Respiratory Rate (RR) on Day -1 of Each Period
Time frame: Day -1 of each period
RR at Screening and Study Exit
Time frame: Screening and study exit
Temperature on Day -1 of Each Period
Time frame: Day -1 of each period
Temperature at Screening and Study Exit
Time frame: Screening and study exit
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG)
Time frame: Screening up to study exit (approximately 6.5 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Zavegepant 100mg non-enteric coated soft gel capsule, Zavegepant 100mg immediate release tablet and Zavegepant 2 x 100mg immediate release tablets in people with Biological Availability, run by Pfizer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of Zavegepant (time frame: 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.