Trial Outcomes & Findings for A Study to Learn About the Study Medication, Zavegepant, in Healthy Volunteers (NCT NCT06137703)
NCT ID: NCT06137703
Last Updated: 2024-10-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
52 participants
Primary outcome timeframe
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
Results posted on
2024-10-01
Participant Flow
A total of 52 participants were assigned to study interventions.
Participant milestones
| Measure |
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.
|
Sequence BADC
Participants were assigned to Sequence BADC, 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 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.
|
Sequence ACBD
Participants were assigned to Sequence ACBD, 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 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.
|
Sequence CDAB
Participants were assigned to Sequence CDAB, 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 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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
13
|
13
|
|
Overall Study
COMPLETED
|
13
|
12
|
12
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
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.
|
Sequence BADC
Participants were assigned to Sequence BADC, 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 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.
|
Sequence ACBD
Participants were assigned to Sequence ACBD, 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 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.
|
Sequence CDAB
Participants were assigned to Sequence CDAB, 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 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.
|
|---|---|---|---|---|
|
Overall Study
Other
|
0
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Learn About the Study Medication, Zavegepant, in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
All Participants
n=52 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.
|
|---|---|
|
Age, Customized
18-65 years of age
|
37.0 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
51 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hawaiian
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
41 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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 dosePopulation: Included all participants who received at least 1 dose of zavegepant, and for whom the pharmacokinetic (PK) profile had been adequately characterized.
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.
Outcome measures
| Measure |
Treatment A: Zavegepant 100 mg SGC
n=48 Participants
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.
|
Treatment B: Zavegepant 100 mg IR+DDM
n=47 Participants
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.
|
Treatment C: Zavegepant 200 mg IR+DDM
n=47 Participants
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.
|
Treatment D: Zavegepant 4*25 mg SGC
n=40 Participants
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.
|
|---|---|---|---|---|
|
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of Zavegepant
|
83.65 Hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 52
|
102.5 Hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 66
|
184.4 Hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 73
|
47.29 Hours*nanograms per milliliter (h*ng/mL)
Geometric Coefficient of Variation 51
|
PRIMARY outcome
Timeframe: 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 dosePopulation: Included all participants who received at least 1 dose of zavegepant, and for whom the PK profile had been adequately characterized.
Cmax was observed directly from data.
Outcome measures
| Measure |
Treatment A: Zavegepant 100 mg SGC
n=50 Participants
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.
|
Treatment B: Zavegepant 100 mg IR+DDM
n=51 Participants
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.
|
Treatment C: Zavegepant 200 mg IR+DDM
n=50 Participants
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.
|
Treatment D: Zavegepant 4*25 mg SGC
n=50 Participants
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.
|
|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of Zavegepant
|
36.28 ng/mL
Geometric Coefficient of Variation 68
|
41.20 ng/mL
Geometric Coefficient of Variation 80
|
76.93 ng/mL
Geometric Coefficient of Variation 77
|
12.78 ng/mL
Geometric Coefficient of Variation 82
|
PRIMARY outcome
Timeframe: 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 dosePopulation: Included all participants who received at least 1 dose of zavegepant, and for whom the PK profile had been adequately characterized.
AUClast was calculated using linear/log trapezoidal method.
Outcome measures
| Measure |
Treatment A: Zavegepant 100 mg SGC
n=50 Participants
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.
|
Treatment B: Zavegepant 100 mg IR+DDM
n=51 Participants
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.
|
Treatment C: Zavegepant 200 mg IR+DDM
n=50 Participants
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.
|
Treatment D: Zavegepant 4*25 mg SGC
n=50 Participants
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.
|
|---|---|---|---|---|
|
AUClast of Zavegepant
|
82.13 h*ng/mL
Geometric Coefficient of Variation 54
|
96.25 h*ng/mL
Geometric Coefficient of Variation 66
|
175.5 h*ng/mL
Geometric Coefficient of Variation 72
|
42.25 h*ng/mL
Geometric Coefficient of Variation 54
|
SECONDARY outcome
Timeframe: 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 dosePopulation: Included all participants who received at least 1 dose of zavegepant, and for whom the PK profile had been adequately characterized.
Tmax was observed directly from data as time of first occurrence.
Outcome measures
| Measure |
Treatment A: Zavegepant 100 mg SGC
n=50 Participants
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.
|
Treatment B: Zavegepant 100 mg IR+DDM
n=51 Participants
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.
|
Treatment C: Zavegepant 200 mg IR+DDM
n=50 Participants
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.
|
Treatment D: Zavegepant 4*25 mg SGC
n=50 Participants
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.
|
|---|---|---|---|---|
|
Time to Reach Cmax (Tmax) of Zavegepant
|
0.9830 Hours
Interval 0.483 to 3.0
|
0.5000 Hours
Interval 0.25 to 2.62
|
0.5000 Hours
Interval 0.233 to 2.48
|
2.000 Hours
Interval 0.483 to 5.0
|
SECONDARY outcome
Timeframe: 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 dosePopulation: Included all participants who received at least 1 dose of zavegepant, and for whom the PK profile had been adequately characterized.
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.
Outcome measures
| Measure |
Treatment A: Zavegepant 100 mg SGC
n=48 Participants
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.
|
Treatment B: Zavegepant 100 mg IR+DDM
n=47 Participants
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.
|
Treatment C: Zavegepant 200 mg IR+DDM
n=47 Participants
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.
|
Treatment D: Zavegepant 4*25 mg SGC
n=40 Participants
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.
|
|---|---|---|---|---|
|
Terminal Phase Half-Life (t1/2) of Zavegepant
|
8.346 Hours
Standard Deviation 1.3101
|
8.907 Hours
Standard Deviation 2.3611
|
8.243 Hours
Standard Deviation 1.3004
|
9.149 Hours
Standard Deviation 1.5552
|
SECONDARY outcome
Timeframe: 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-dosePopulation: Included all participants who received at least 1 dose of zavegepant, and for whom the PK profile had been adequately characterized.
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.
Outcome measures
| Measure |
Treatment A: Zavegepant 100 mg SGC
n=48 Participants
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.
|
Treatment B: Zavegepant 100 mg IR+DDM
n=47 Participants
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.
|
Treatment C: Zavegepant 200 mg IR+DDM
n=47 Participants
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.
|
Treatment D: Zavegepant 4*25 mg SGC
n=40 Participants
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.
|
|---|---|---|---|---|
|
Apparent Clearance (CL/F) of Zavegepant From Plasma
|
1195 liters per hour (L/h)
Geometric Coefficient of Variation 52
|
975.5 liters per hour (L/h)
Geometric Coefficient of Variation 66
|
1085 liters per hour (L/h)
Geometric Coefficient of Variation 73
|
2115 liters per hour (L/h)
Geometric Coefficient of Variation 51
|
SECONDARY outcome
Timeframe: 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 dosePopulation: Included all participants who received at least 1 dose of zavegepant, and for whom the PK profile had been adequately characterized.
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.
Outcome measures
| Measure |
Treatment A: Zavegepant 100 mg SGC
n=48 Participants
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.
|
Treatment B: Zavegepant 100 mg IR+DDM
n=47 Participants
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.
|
Treatment C: Zavegepant 200 mg IR+DDM
n=47 Participants
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.
|
Treatment D: Zavegepant 4*25 mg SGC
n=40 Participants
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.
|
|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) of Zavegepant
|
14230 L
Geometric Coefficient of Variation 60
|
12250 L
Geometric Coefficient of Variation 79
|
12740 L
Geometric Coefficient of Variation 85
|
27530 L
Geometric Coefficient of Variation 59
|
SECONDARY outcome
Timeframe: Baseline up to study exit (approximately 6.5 weeks)Population: Included all participants who received at least 1 dose of any study intervention.
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.
Outcome measures
| Measure |
Treatment A: Zavegepant 100 mg SGC
n=51 Participants
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.
|
Treatment B: Zavegepant 100 mg IR+DDM
n=51 Participants
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.
|
Treatment C: Zavegepant 200 mg IR+DDM
n=50 Participants
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.
|
Treatment D: Zavegepant 4*25 mg SGC
n=50 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants with at least 1 Severe TEAEs
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants with at least 1 TEAE
|
3 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants with at least 1 treatment-related TEAE
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants with at least 1 Serious TEAEs
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to study exit (approximately 6.5 weeks)Population: Included all participants who received at least 1 dose of any study intervention.
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.
Outcome measures
| Measure |
Treatment A: Zavegepant 100 mg SGC
n=52 Participants
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.
|
Treatment B: Zavegepant 100 mg IR+DDM
n=52 Participants
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.
|
Treatment C: Zavegepant 200 mg IR+DDM
n=52 Participants
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.
|
Treatment D: Zavegepant 4*25 mg SGC
n=52 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Urinalysis - Abnormal Urine Leukocytes
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Hematology - Hemoglobin<lower limit of normal
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Urinalysis - Abnormal Leukocyte Esterase
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day -1, pre-dose and 2 hours post dose on Day 1 of each periodPopulation: 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.
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.
Outcome measures
| Measure |
Treatment A: Zavegepant 100 mg SGC
n=51 Participants
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.
|
Treatment B: Zavegepant 100 mg IR+DDM
n=51 Participants
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.
|
Treatment C: Zavegepant 200 mg IR+DDM
n=50 Participants
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.
|
Treatment D: Zavegepant 4*25 mg SGC
n=50 Participants
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.
|
|---|---|---|---|---|
|
Blood Pressure on Day -1 and Day 1 of Each Period
SBP on Day -1
|
115.0 millimeter of mercury (mm Hg)
Interval 99.0 to 137.0
|
115.0 millimeter of mercury (mm Hg)
Interval 99.0 to 140.0
|
116.5 millimeter of mercury (mm Hg)
Interval 94.0 to 140.0
|
116.5 millimeter of mercury (mm Hg)
Interval 97.0 to 138.0
|
|
Blood Pressure on Day -1 and Day 1 of Each Period
Pre-dose SBP on Day 1 of each period
|
113.0 millimeter of mercury (mm Hg)
Interval 74.0 to 132.0
|
113.0 millimeter of mercury (mm Hg)
Interval 93.0 to 132.0
|
114.0 millimeter of mercury (mm Hg)
Interval 92.0 to 144.0
|
114.5 millimeter of mercury (mm Hg)
Interval 94.0 to 138.0
|
|
Blood Pressure on Day -1 and Day 1 of Each Period
SBP at 2 hours post dose on Day 1 of each period
|
113.0 millimeter of mercury (mm Hg)
Interval 94.0 to 150.0
|
114.0 millimeter of mercury (mm Hg)
Interval 94.0 to 135.0
|
113.5 millimeter of mercury (mm Hg)
Interval 91.0 to 144.0
|
113.0 millimeter of mercury (mm Hg)
Interval 92.0 to 137.0
|
|
Blood Pressure on Day -1 and Day 1 of Each Period
DBP at Day -1
|
75.0 millimeter of mercury (mm Hg)
Interval 62.0 to 90.0
|
77.0 millimeter of mercury (mm Hg)
Interval 59.0 to 89.0
|
76.0 millimeter of mercury (mm Hg)
Interval 64.0 to 92.0
|
76.0 millimeter of mercury (mm Hg)
Interval 60.0 to 92.0
|
|
Blood Pressure on Day -1 and Day 1 of Each Period
Pre-dose DBP on Day 1 of each period
|
75.0 millimeter of mercury (mm Hg)
Interval 52.0 to 92.0
|
76.0 millimeter of mercury (mm Hg)
Interval 63.0 to 90.0
|
74.0 millimeter of mercury (mm Hg)
Interval 64.0 to 89.0
|
76.0 millimeter of mercury (mm Hg)
Interval 63.0 to 90.0
|
|
Blood Pressure on Day -1 and Day 1 of Each Period
DBP at 2 hours post dose on Day 1 of each period
|
75.0 millimeter of mercury (mm Hg)
Interval 57.0 to 100.0
|
76.0 millimeter of mercury (mm Hg)
Interval 62.0 to 97.0
|
77.0 millimeter of mercury (mm Hg)
Interval 61.0 to 91.0
|
75.0 millimeter of mercury (mm Hg)
Interval 66.0 to 88.0
|
SECONDARY outcome
Timeframe: Screening and study exitPopulation: 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.
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.
Outcome measures
| Measure |
Treatment A: Zavegepant 100 mg SGC
n=52 Participants
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Blood Pressure at Screening and Study Exit
SBP at Screening
|
121.5 mm Hg
Interval 102.0 to 144.0
|
—
|
—
|
—
|
|
Blood Pressure at Screening and Study Exit
SBP at study exit
|
114.0 mm Hg
Interval 94.0 to 137.0
|
—
|
—
|
—
|
|
Blood Pressure at Screening and Study Exit
DBP at Screening
|
82.0 mm Hg
Interval 65.0 to 91.0
|
—
|
—
|
—
|
|
Blood Pressure at Screening and Study Exit
DBP at study exit
|
76.0 mm Hg
Interval 63.0 to 90.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -1, pre-dose and 2 hours post dose on Day 1 of each periodPopulation: 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.
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.
Outcome measures
| Measure |
Treatment A: Zavegepant 100 mg SGC
n=51 Participants
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.
|
Treatment B: Zavegepant 100 mg IR+DDM
n=51 Participants
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.
|
Treatment C: Zavegepant 200 mg IR+DDM
n=50 Participants
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.
|
Treatment D: Zavegepant 4*25 mg SGC
n=50 Participants
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.
|
|---|---|---|---|---|
|
Heart Rate (HR) on Day -1 and Day 1 of Each Period
Pre-dose HR on Day 1 of each period
|
73.0 Beats per minute (beats/min)
Interval 51.0 to 93.0
|
74.0 Beats per minute (beats/min)
Interval 47.0 to 99.0
|
73.5 Beats per minute (beats/min)
Interval 52.0 to 103.0
|
73.5 Beats per minute (beats/min)
Interval 51.0 to 110.0
|
|
Heart Rate (HR) on Day -1 and Day 1 of Each Period
HR at 2 hours post dose on Day 1 of each period
|
71.0 Beats per minute (beats/min)
Interval 51.0 to 97.0
|
70.0 Beats per minute (beats/min)
Interval 48.0 to 90.0
|
71.0 Beats per minute (beats/min)
Interval 48.0 to 108.0
|
70.0 Beats per minute (beats/min)
Interval 50.0 to 99.0
|
|
Heart Rate (HR) on Day -1 and Day 1 of Each Period
HR on Day -1
|
71.0 Beats per minute (beats/min)
Interval 50.0 to 102.0
|
72.0 Beats per minute (beats/min)
Interval 49.0 to 102.0
|
73.0 Beats per minute (beats/min)
Interval 50.0 to 99.0
|
73.0 Beats per minute (beats/min)
Interval 56.0 to 100.0
|
SECONDARY outcome
Timeframe: Screening and study exitPopulation: 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.
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.
Outcome measures
| Measure |
Treatment A: Zavegepant 100 mg SGC
n=52 Participants
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
HR at Screening and Study Exit
HR at Screening
|
65.0 beats/min
Interval 46.0 to 93.0
|
—
|
—
|
—
|
|
HR at Screening and Study Exit
HR at study exit
|
74.0 beats/min
Interval 53.0 to 100.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -1 of each periodPopulation: 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 RR on Day -1.
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.
Outcome measures
| Measure |
Treatment A: Zavegepant 100 mg SGC
n=46 Participants
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.
|
Treatment B: Zavegepant 100 mg IR+DDM
n=46 Participants
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.
|
Treatment C: Zavegepant 200 mg IR+DDM
n=45 Participants
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.
|
Treatment D: Zavegepant 4*25 mg SGC
n=45 Participants
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.
|
|---|---|---|---|---|
|
Respiratory Rate (RR) on Day -1 of Each Period
|
14.0 Breaths per minute (breaths/min)
Interval 12.0 to 18.0
|
14.0 Breaths per minute (breaths/min)
Interval 12.0 to 16.0
|
14.0 Breaths per minute (breaths/min)
Interval 12.0 to 18.0
|
14.0 Breaths per minute (breaths/min)
Interval 12.0 to 18.0
|
SECONDARY outcome
Timeframe: Screening and study exitPopulation: 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.
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.
Outcome measures
| Measure |
Treatment A: Zavegepant 100 mg SGC
n=52 Participants
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
RR at Screening and Study Exit
RR at Screening
|
14.0 breaths/min
Interval 12.0 to 16.0
|
—
|
—
|
—
|
|
RR at Screening and Study Exit
RR at study exit
|
14.0 breaths/min
Interval 12.0 to 18.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -1 of each periodPopulation: 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.
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 ℃.
Outcome measures
| Measure |
Treatment A: Zavegepant 100 mg SGC
n=46 Participants
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.
|
Treatment B: Zavegepant 100 mg IR+DDM
n=46 Participants
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.
|
Treatment C: Zavegepant 200 mg IR+DDM
n=45 Participants
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.
|
Treatment D: Zavegepant 4*25 mg SGC
n=45 Participants
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.
|
|---|---|---|---|---|
|
Temperature on Day -1 of Each Period
|
36.60 Degree Celsius (℃)
Interval 36.1 to 37.6
|
36.40 Degree Celsius (℃)
Interval 35.9 to 37.0
|
36.50 Degree Celsius (℃)
Interval 35.9 to 37.2
|
36.50 Degree Celsius (℃)
Interval 36.1 to 37.4
|
SECONDARY outcome
Timeframe: Screening and study exitPopulation: Included all participants who received at least 1 dose of any study intervention.
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 ℃.
Outcome measures
| Measure |
Treatment A: Zavegepant 100 mg SGC
n=52 Participants
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Temperature at Screening and Study Exit
Temperature at Screening
|
36.40 ℃
Interval 35.9 to 36.8
|
—
|
—
|
—
|
|
Temperature at Screening and Study Exit
Temperature at study exit
|
36.60 ℃
Interval 35.8 to 37.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening up to study exit (approximately 6.5 weeks)Population: Included all participants who received at least 1 dose of any study intervention.
ECG was measured after the participants had been resting for at least 5 minutes in a seated position.
Outcome measures
| Measure |
Treatment A: Zavegepant 100 mg SGC
n=52 Participants
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG)
ECG Mean Heart Rate
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG)
PR Interval, Aggregate
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG)
QRS Duration, Aggregate
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG)
QT Interval, Aggregate
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG)
QTc corrected using Bazett's formula (QTcB) Interval, Aggregate
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG)
QTc corrected using Fridericia's formula (QTcF) Interval, Aggregate
|
0 Participants
|
—
|
—
|
—
|
Adverse Events
Treatment A: Zavegepant 100 mg SGC
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Treatment B: Zavegepant 100 mg IR+DDM
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Treatment C: Zavegepant 200 mg IR+DDM
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Treatment D: Zavegepant 4*25 mg SGC
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment A: Zavegepant 100 mg SGC
n=51 participants at risk
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.
|
Treatment B: Zavegepant 100 mg IR+DDM
n=51 participants at risk
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.
|
Treatment C: Zavegepant 200 mg IR+DDM
n=50 participants at risk
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.
|
Treatment D: Zavegepant 4*25 mg SGC
n=50 participants at risk
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.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
1/51 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/51 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
2.0%
1/51 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/51 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
Other adverse events
| Measure |
Treatment A: Zavegepant 100 mg SGC
n=51 participants at risk
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.
|
Treatment B: Zavegepant 100 mg IR+DDM
n=51 participants at risk
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.
|
Treatment C: Zavegepant 200 mg IR+DDM
n=50 participants at risk
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.
|
Treatment D: Zavegepant 4*25 mg SGC
n=50 participants at risk
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.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Skin abrasion
|
2.0%
1/51 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/51 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
4.0%
2/50 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
2.0%
1/50 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/51 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
2.0%
1/51 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
2.0%
1/50 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Alanine aminotransferase increased
|
2.0%
1/51 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/51 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
2.0%
1/51 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/51 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Blood bilirubin increased
|
2.0%
1/51 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/51 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Lipase increased
|
2.0%
1/51 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/51 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
White blood cells urine positive
|
2.0%
1/51 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/51 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/51 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
2.0%
1/51 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
2.0%
1/50 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
2.0%
1/50 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/51 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
2.0%
1/51 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Syncope
|
0.00%
0/51 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/51 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
2.0%
1/50 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
1/51 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/51 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/51 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/51 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.0%
1/51 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/51 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/51 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/51 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
2.0%
1/50 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
2.0%
1/51 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/51 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Urinary tract infection
|
2.0%
1/51 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/51 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/50 • Screening up to study exit (approximately 6.5 weeks)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
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