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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003308-42 | EudraCT Number |
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The purpose of this study is to estimate the effect of a strong inhibitor of CYP3A4 (itraconazole) on the pharmacokinetics (PK) of PF-07321332/ritonavir in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1 | Experimental | PF-07321332/ritonavir orally |
|
| Period 2 | Experimental | Itraconazole + PF-07321332/ritonavir orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07321332/ritonavir | Drug | Administered orally every 12 hours for days for a total of 5 doses from Day 1 through Day 3 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) of PF-07321332 | The Cmax of PF-07321332 in the study was observed directly from data. | Days 1, 2, 3 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, and 48 hours postdose on Day 3) in Period 1; Days 1, 4, 5, 6 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, and 72 hours postdose on Day 6) of Period 2. |
| Area Under the Plasma Concentration-time Profile From Time Zero to Time Tau (τ), Where Tau=12-hour Dosing Interval(AUCtau) for PF-07321332 | The AUCtau of PF-07321332 was determined by Linear/Log trapezoidal method. | Days 1, 2, 3 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, and 48 hours postdose on Day 3) in Period 1; Days 1, 4, 5, 6 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, and 72 hours postdose on Day 6) of Period 2. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An Adverse event (AE) was any untoward medical occurrence in a participant. A serious AE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth, was a suspected transmission via a Pfizer product of an infectious agent,pathogenic or non-pathogenic, was considered serious. The focus of AE summaries was on treatment-emergent AE (TEAE). An AE was considered TEAE if the event occurred during the on-treatment period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brussels Clinical Research Unit | Brussels | Bruxelles-capitale, Région de | B-1070 | Belgium |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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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This was a 2-period,fixed-sequence crossover study. A total of 12 participants were assigned to and received the treatment in period 1. One participant discontinued due to withdrawal. The remaining 11 participants completed Period 1 and continued to receive the treatment in Period 2 and all completed Period 2.
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| ID | Title | Description |
|---|---|---|
| FG000 | PF-07321332 (Suspension)/Ritonavir 300/100 mg BID, Fasted | Participants received PF-07321332/ritonavir 300/100 mg administered orally every 12 hours for a total of 5 doses, from Day 1 morning to Day 3 morning of Period 1. |
| FG001 | Itraconazole 200 mg QD + PF-07321332(Suspension)/Ritonavir 300/100 mg BID, Fasted | Participants received itraconazole 200 mg orally once a day from Days 1 through 8 of Period 2, for a total of 8 doses; and PF-07321332/ritonavir 300/100 mg administered orally every 12 hours from Days 4 through 6 of Period 2, for a total of 5 doses. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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The baseline analysis population included all participants enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | All participants who received PF-07321332 (suspension)/ritonavir 300/100 mg, Itraconazole 200 mg and PF-07321332(suspension)/ritonavir 300/100 mg in Period 1 and 2, respectively. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Observed Concentration (Cmax) of PF-07321332 | The Cmax of PF-07321332 in the study was observed directly from data. | The analysis population included all participants who took at least 1 dose of study intervention and in whom at least 1 concentration value was reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Days 1, 2, 3 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, and 48 hours postdose on Day 3) in Period 1; Days 1, 4, 5, 6 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, and 72 hours postdose on Day 6) of Period 2. |
|
From screening up to Day 35.
Serious adverse events(SAE) and non-serious AEs were recorded on the case report form.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PF-07321332 (Suspension)/Ritonavir 300/100 mg BID, Fasted | Participants received PF-07321332/ritonavir 300/100 mg administered orally every 12 hours for a total of 5 doses, from Day 1 morning to Day 3 morning in Period 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block first degree | Cardiac disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 2, 2021 | Aug 11, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 20, 2021 | Aug 11, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000719967 | nirmatrelvir and ritonavir drug combination |
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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This is a Phase I, fixed sequence, 2-period study to evaluate the effect of the strong CYP3A4 inhibitor, itraconazole, on the PK of PF-07321332 and ritonavir in healthy participants. A total of 12 healthy participants will be enrolled into this study.
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| Itraconazole | Drug | Administered orally once daily for 8 days from Days 1 through 8 |
|
| PF-07321332/ritonavir | Drug | Administered orally BID for 3 day for a total on 5 doses starting on Day 4 through Day 6 |
|
| Screening up to Day 35 |
| Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) | Safety laboratory assessments included urinalysis, hematology, chemistry and other. All the safety laboratory samples were collected following at least a 4-hour fast. | Screening up to Day 9 of Period 2 or Early termination/discontinuation. |
| Number of Participants With Clinically Significant 12-lead Electrocardiogram (ECG) Findings | Triplicate 12-lead ECG readings approximately 2 minutes apart were taken at each test. All ECG assessments were made after at least a 5-minute rest in a supine position and prior to any blood draws or vital sign measurements. | Screening up to Day 9 of Period 2 or Early termination/discontinuation. |
| Change From Baseline in Vital Signs Data - Supine Systolic Blood Pressure | Vital signs(systolic and diastolic blood pressure, and pulse rate) were measured with participants after having a rest for at least 5 minutes in a supine position. Vital signs assessment were performed after collection of ECGs and prior to collection of blood draws if scheduled at the same time. | Screening up to Day 9 of Period 2 or Early termination/discontinuation. |
| Change From Baseline in Vital Signs Data - Supine Diastolic Blood Pressure | Vital signs(systolic and diastolic blood pressure, and pulse rate) were measured with participants after having a rest for at least 5 minutes in a supine position. Vital signs assessment were performed after collection of ECGs and prior to collection of blood draws if scheduled at the same time. | Screening up to Day 9 of Period 2 or Early termination/discontinuation. |
| Change From Baseline in Vital Signs Data - Supine Pulse Rate | Vital signs(systolic and diastolic blood pressure, and pulse rate) were measured with participants after having a rest for at least 5 minutes in a supine position. Vital signs assessment were performed after collection of ECGs and prior to collection of blood draws if scheduled at the same time. | Screening up to Day 9 of Period 2 or Early termination/discontinuation. |
| Time for Cmax (Tmax) for PF-07321332 | PF-07321332 Tmax was observed directed from data | Days 1, 2, 3 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, and 48 hours postdose on Day 3) in Period 1; Days 1, 4, 5, 6 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, and 72 hours postdose on Day 6) of Period 2 |
| Terminal Half-life(t1/2) of PF-07321332 | Terminal half-life was defined as the time measured for the plasma concentration of drug to decrease by one half. | Days 1, 2, 3 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, and 48 hours postdose on Day 3) in Period 1; Days 1, 4, 5, 6 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, and 72 hours postdose on Day 6) of Period 2 |
| Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration(AUClast) of PF-07321332 | AUClast of PF-07321332 was determined by Linear/Log trapezoidal method. | Days 1, 2, 3 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, and 48 hours postdose on Day 3) in Period 1; Days 1, 4, 5, 6 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, and 72 hours postdose on Day 6) of Period 2. |
| Apparent Clearance(CL/F) of PF-07321332 | CL/F was apparent clearance. | Days 1, 2, 3 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, and 48 hours postdose on Day 3) in Period 1; Days 1, 4, 5, 6 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, and 72 hours postdose on Day 6) of Period 2. |
| Apparent Volume of Distribution (Vz/F) of PF-07321332 | Vz/F was apparent volume of distribution. | Days 1, 2, 3 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, and 48 hours postdose on Day 3) in Period 1; Days 1, 4, 5, 6 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, and 72 hours postdose on Day 6) of Period 2. |
| NOT COMPLETED |
|
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 |
| Itraconazole 200 mg QD + PF-07321332(Suspension)/Ritonavir 300/100 mg BID, Fasted |
Participants received itraconazole 200 mg orally once a day from Days 1 through 8 of Period 2, for a total of 8 doses; and PF-07321332/ritonavir 300/100 mg administered orally every 12 hours from Days 4 through 6 of Period 2, for a total of 5 doses. |
|
|
|
| Primary | Area Under the Plasma Concentration-time Profile From Time Zero to Time Tau (τ), Where Tau=12-hour Dosing Interval(AUCtau) for PF-07321332 | The AUCtau of PF-07321332 was determined by Linear/Log trapezoidal method. | The analysis population included all participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Days 1, 2, 3 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, and 48 hours postdose on Day 3) in Period 1; Days 1, 4, 5, 6 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, and 72 hours postdose on Day 6) of Period 2. |
|
|
|
|
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An Adverse event (AE) was any untoward medical occurrence in a participant. A serious AE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth, was a suspected transmission via a Pfizer product of an infectious agent,pathogenic or non-pathogenic, was considered serious. The focus of AE summaries was on treatment-emergent AE (TEAE). An AE was considered TEAE if the event occurred during the on-treatment period. | The analysis population included all participants who took at least 1 dose of study intervention. Participants was analyzed according to the product they actually received. | Posted | Count of Participants | Participants | Screening up to Day 35 |
|
|
|
| Secondary | Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) | Safety laboratory assessments included urinalysis, hematology, chemistry and other. All the safety laboratory samples were collected following at least a 4-hour fast. | The analysis population included all participants who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Screening up to Day 9 of Period 2 or Early termination/discontinuation. |
|
|
|
| Secondary | Number of Participants With Clinically Significant 12-lead Electrocardiogram (ECG) Findings | Triplicate 12-lead ECG readings approximately 2 minutes apart were taken at each test. All ECG assessments were made after at least a 5-minute rest in a supine position and prior to any blood draws or vital sign measurements. | The analysis population included all participants who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | No | Screening up to Day 9 of Period 2 or Early termination/discontinuation. |
|
|
|
| Secondary | Change From Baseline in Vital Signs Data - Supine Systolic Blood Pressure | Vital signs(systolic and diastolic blood pressure, and pulse rate) were measured with participants after having a rest for at least 5 minutes in a supine position. Vital signs assessment were performed after collection of ECGs and prior to collection of blood draws if scheduled at the same time. | The analysis population included all participants who took at least 1 dose of study intervention. | Posted | Mean | Standard Deviation | mmHg | Screening up to Day 9 of Period 2 or Early termination/discontinuation. |
|
|
|
| Secondary | Change From Baseline in Vital Signs Data - Supine Diastolic Blood Pressure | Vital signs(systolic and diastolic blood pressure, and pulse rate) were measured with participants after having a rest for at least 5 minutes in a supine position. Vital signs assessment were performed after collection of ECGs and prior to collection of blood draws if scheduled at the same time. | The analysis population included all participants who took at least 1 dose of study intervention. | Posted | Mean | Standard Deviation | mmHg | Screening up to Day 9 of Period 2 or Early termination/discontinuation. |
|
|
|
| Secondary | Change From Baseline in Vital Signs Data - Supine Pulse Rate | Vital signs(systolic and diastolic blood pressure, and pulse rate) were measured with participants after having a rest for at least 5 minutes in a supine position. Vital signs assessment were performed after collection of ECGs and prior to collection of blood draws if scheduled at the same time. | The analysis population included all participants who took at least 1 dose of study intervention. | Posted | Mean | Standard Deviation | beats per minute(bpm) | Screening up to Day 9 of Period 2 or Early termination/discontinuation. |
|
|
|
| Secondary | Time for Cmax (Tmax) for PF-07321332 | PF-07321332 Tmax was observed directed from data | The analysis population included all participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. | Posted | Median | Full Range | hours(hr) | Days 1, 2, 3 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, and 48 hours postdose on Day 3) in Period 1; Days 1, 4, 5, 6 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, and 72 hours postdose on Day 6) of Period 2 |
|
|
|
| Secondary | Terminal Half-life(t1/2) of PF-07321332 | Terminal half-life was defined as the time measured for the plasma concentration of drug to decrease by one half. | The analysis population included all participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, "Number of Participants analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | hours(hr) | Days 1, 2, 3 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, and 48 hours postdose on Day 3) in Period 1; Days 1, 4, 5, 6 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, and 72 hours postdose on Day 6) of Period 2 |
|
|
|
| Secondary | Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration(AUClast) of PF-07321332 | AUClast of PF-07321332 was determined by Linear/Log trapezoidal method. | The analysis population included all participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Days 1, 2, 3 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, and 48 hours postdose on Day 3) in Period 1; Days 1, 4, 5, 6 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, and 72 hours postdose on Day 6) of Period 2. |
|
|
|
| Secondary | Apparent Clearance(CL/F) of PF-07321332 | CL/F was apparent clearance. | The analysis population included all participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/hr | Days 1, 2, 3 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, and 48 hours postdose on Day 3) in Period 1; Days 1, 4, 5, 6 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, and 72 hours postdose on Day 6) of Period 2. |
|
|
|
| Secondary | Apparent Volume of Distribution (Vz/F) of PF-07321332 | Vz/F was apparent volume of distribution. | The analysis population included all participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, "Number of Participants analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | L | Days 1, 2, 3 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, and 48 hours postdose on Day 3) in Period 1; Days 1, 4, 5, 6 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, and 72 hours postdose on Day 6) of Period 2. |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 7 |
| 12 |
| EG001 | Itraconazole 200 mg QD + PF-07321332(Suspension)/Ritonavir 300/100 mg BID, Fasted | Participants received itraconazole 200 mg orally once a day from Days 1 through 8 of Period 2, for a total of 8 doses; and PF-07321332/ritonavir 300/100 mg administered orally every 12 hours from Days 4 through 6 of Period 2, for a total of 5 doses. | 0 | 11 | 0 | 11 | 10 | 11 |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Anorectal discomfort | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Breath odour | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Change of bowel habit | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Eructation | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Gastrointestinal motility disorder | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Restless legs syndrome | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Testicular pain | Reproductive system and breast disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Feeling hot | General disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Influenza like illness | General disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Injection site pain | General disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Vessel puncture site haematoma | General disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Vessel puncture site pain | General disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Ear discomfort | Ear and labyrinth disorders | MedDRA v24.0 | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D010879 |
| Piperazines |
| Fibrinogen(mg/dl) > 1.25 ✖ Baseline |
|
| Leukocyte Esterase >= 1 |
|
| QRS Duration, Aggregate (msec) Value >= 140 |
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| QRS Duration, Aggregate (msec) %Change >= 50% |
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| QTcF interval, Aggregate (msec) 450 < Value < = 480 |
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| QTcF interval, Aggregate (msec) 480 < Value < = 500 |
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| QTcF interval, Aggregate (msec) Value > 500 |
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| QTcF interval, Aggregate (msec) 30 < Change < = 60 |
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| QTcF interval, Aggregate (msec) Change > 60 |
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| Period 1/Day 3 1H 30min |
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| Period 2/Day 4 0H |
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| Period 2/Day6 0H |
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| Period 2/Day6 1H |
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| Period 2/Day6 1H 30min |
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| Period 2/Day6 72 H |
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| Period 1/Day 3 1H 30min |
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| Period 2/Day 4 0H |
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| Period 2/Day 6 0H |
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| Period 2/Day 6 1H |
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| Period 2/Day 6 1H 30min |
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| Period 2/Day 6 72H |
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| Period 1/Day 3 1 H 30 min |
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| Period 2/Day 4 0 H |
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| Period 2/Day 6 0 H |
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| Period 2/Day 6 1 H |
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| Period 2/Day 6 1 H 30 min |
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| Period 2/Day 6 72 H |
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