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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-006073-30 | EudraCT Number |
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A Phase 1, double blind, sponsor open, single and multiple ascending dose study to evaluate safety, tolerability and pharmacokinetics of PF-07321332 in healthy participants.
Combined 5-part study. Part-1: Single Ascending dose Part-2: Multiple Ascending Dose Part-3: Relative bioavailability and food effect Part-4: Metabolism and Excretion Part-5: Supra-therapeutic Exposure Part-1,2 and 5 are double blind, sponsor open and Part-3 and 4 are open label study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-07321332 Dose 1 | Experimental | Dose level 1 of PF-07321332 |
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| PF-07321332 Dose 2 | Experimental | Dose level 2 of PF-07321332 |
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| PF-07321332 Dose 3 | Experimental | Dose level 3 of PF-07321332 |
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| PF-07321332 Dose 4 | Experimental | Dose level 4 of PF-07321332 |
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| PF-07321332 Dose 5 | Experimental | Dose level 5 of PF-07321332 |
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| PF-07321332 Dose 4 (Fed) | Experimental | Dose level 4 of PF-07321332 with high fat meal |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07321332 Dose 1 | Drug | PF-07321332 Dose 1 or Placebo |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) in PART-1: SAD | An Adverse Event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were those with initial onset or increasing in severity between the first dose of study intervention and up to 36 days after last dose of study intervention. A serious adverse event (SAE) 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 AEs and SAEs were determined by the investigator. | Post the single dose of study intervention till up to 36 days |
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs in PART-1: SAD | Vital signs (temperature, respiratory rate, pulse rate [PR], systolic blood pressure [SBP], and diastolic blood pressure [DBP]) were obtained with participants following at least 5 minutes of supine rest. Categorical criteria were defined as DBP: value <50 millimeters of mercury (mm Hg), increase >=20 mm Hg, or decrease >=20 mm Hg; PR: value <40 beats per minute (bpm) or value >120 bpm; SBP: value <90 mm Hg, increase >=30 mm Hg, or decrease >=30 mm Hg. Clinical significance of vital signs was determined at the investigator's discretion. The analysis population included all participants who received at least 1 dose of study intervention and had at least 1 assessment undertaken post treatment. | Baseline up to Day 2 of the final period |
| Number of Participants With Laboratory Abnormalities in PART-1: SAD | Laboratory parameters included hematology, chemistry, urinalysis, and other (urine drug screening, Severe Acute Respiratory Syndrome Coronavirus 2 [SARS-CoV-2] reverse transcription polymerase chain reaction [RT-PCR], estimated glomerular filtration rate [eGFR], pregnancy test [beta human chorionic gonadotropin [b-hCG]], activated partial thromboplastin time [aPTT], prothrombin time [PT] - international normalized ratio [INR], fibrinogen, thyroid stimulating hormone [TSH], Free thyroxine [T4]). The clinical significance of laboratory parameters was determined at the investigator's discretion. The analysis population included all participants who received at least 1 dose of the study intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Plasma PF-07321332 in PART-1: SAD | Cmax is maximum plasma concentration. It was observed directly from data. | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
| Time for Cmax (Tmax) of Plasma PF-07321332 in PART-1: SAD |
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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 |
|---|---|---|---|---|---|---|
| New Haven Clinical Research Unit | New Haven | Connecticut | 06511 | United States | ||
| Pfizer Clinical Research Unit - Brussels |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35388471 | Derived | Singh RSP, Toussi SS, Hackman F, Chan PL, Rao R, Allen R, Van Eyck L, Pawlak S, Kadar EP, Clark F, Shi H, Anderson AS, Binks M, Menon S, Nucci G, Bergman A. Innovative Randomized Phase I Study and Dosing Regimen Selection to Accelerate and Inform Pivotal COVID-19 Trial of Nirmatrelvir. Clin Pharmacol Ther. 2022 Jul;112(1):101-111. doi: 10.1002/cpt.2603. Epub 2022 May 4. |
| 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 5-part study combining PART-1: single ascending dose (SAD), PART-2: multiple ascending dose (MAD), PART-3: relative bioavailability/food effect (rBA/FE), PART-4: metabolism and excretion (M&E) and PART-5: supratherapeutic exposure (SE).
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| ID | Title | Description |
|---|---|---|
| FG000 | PART-1: SAD Treatment Sequence 1 | PF-07321332 150 mg (Suspension), Fasted=>PF-07321332 1500 mg (Suspension), Fasted=>Placebo (Suspension)/ritonavir (RTV) 100 mg, Fasted Participants received a single dose of PF-07321332 150 mg under fasted condition in period 1, a single dose of PF-07321332 1500 mg under fasted condition in period 2, a single dose of placebo and a total of 3 doses of RTV 100 mg at -12h, 0h and 12h post-dose under fasted condition in period 3. There was a washout interval of ≥5 days between periods. |
| FG001 | PART-1: SAD Treatment Sequence 2 | PF-07321332 150 mg (Suspension), Fasted=>Placebo (Suspension), Fasted=>PF-07321332 750 mg (Suspension)/RTV 100 mg, Fasted Participants received a single dose of PF-07321332 150 mg under fasted condition in period 1, a single dose of placebo under fasted condition in period 2, a single dose of PF-07321332 750 mg and a total of 3 doses of RTV 100 mg at -12h, 0h and 12h post-dose under fasted condition in period 3. There was a washout interval of ≥5 days between periods. |
| FG002 | PART-1:SAD Treatment Sequence 3 | Placebo (Suspension), Fasted=>PF-07321332 1500 mg (Suspension), Fasted=>PF-07321332 750 mg (suspension)/RTV 100 mg, Fasted Participants received a single dose of placebo under fasted condition in period 1, a single dose of PF-07321332 1500 mg under fasted condition in period 2, a single dose of PF-07321332 750 mg and a total of 3 doses of RTV 100 mg at -12 hour (h), 0h and 12h post-dose under fasted condition in period 3. There was a washout interval of ≥5 days between periods. |
| FG003 | PART-1: SAD Treatment Sequence 4 | PF-07321332 500 mg (Suspension), Fasted=>PF-07321332 250 mg (Suspension)/RTV 100 mg, Fasted=>PF-07321332 250 mg (Suspension)/RTV 100 mg, Fed Participants received a single dose of PF-07321332 500 mg under fasted condition in period 1, a single dose of PF-07321332 250 mg and a total of 3 doses of RTV 100 mg at -12h, 0h and 12h post-dose under fasted condition in period 2, a single dose of PF-07321332 250 mg and a total of 3 doses of RTV 100 mg at -12h, 0h and 12h post-dose under fed condition in period 3. There was a washout interval of ≥5 days between periods. |
| FG004 | PART-1: SAD Treatment Sequence 5 | PF-07321332 500 mg (Suspension), Fasted=>Placebo (Suspension)/RTV 100 mg, Fasted=>Placebo (Suspension)/RTV 100 mg, Fed Participants received a single dose of PF-07321332 500 mg under fasted condition in period 1, a single dose of placebo and a total of 3 doses of RTV 100 mg at -12h, 0h and 12h post-dose under fasted condition in period 2, a single dose of placebo and a total of 3 doses of RTV 100 mg at -12h, 0h and 12h post-dose under fed condition in period 3. There was a washout interval of ≥5 days between periods. |
| FG005 | PART-1: SAD Treatment Sequence 6 | Placebo (Suspension), Fasted=>PF-07321332 250 mg (Suspension)/RTV 100 mg, Fasted=>PF-07321332 250 mg (Suspension)/RTV 100 mg, Fed Participants received a single dose of placebo under fasted condition in period 1, a single dose of PF-07321332 250 mg and a total of 3 doses of RTV 100 mg at -12h, 0h and 12h post-dose under fasted condition in period 2, a single dose of PF-07321332 250 mg and a total of 3 doses of RTV 100 mg at -12h, 0h and 12h post-dose under fed condition in period 3. There was a washout interval of ≥5 days between periods. |
| FG006 | PART-2: MAD Placebo (Suspension)/RTV 100 mg Twice Daily (BID), Fasted | Participants received placebo and RTV 100 mg BID under fasted condition for 10 days. |
| FG007 | PART-2: MAD PF-07321332 (Suspension)/RTV 75/100 mg BID, Fasted | Participants received PF-07321332 75 mg and RTV 100 mg BID under fasted condition for 10 days. |
| FG008 | PART-2: MAD PF-07321332 (Suspension)/RTV 250/100 mg BID, Fasted | Participants received PF-07321332 250 mg and RTV 100 mg BID under fasted condition for 10 days. |
| FG009 | PART-2: MAD PF-07321332 (Suspension)/RTV 500/100 mg BID, Fasted | Participants received PF-07321332 500 mg and RTV 100 mg BID under fasted condition for 10 days. |
| FG010 | PART-2: MAD Placebo (Suspension)/RTV100 mg BID, Fasted, Japanese | Japanese participants received placebo and RTV 100 mg BID under fasted condition for 10 days. |
| FG011 | PART-2: MAD PF-07321332 (Suspension)/RTV 250/100 mg BID, Fasted, Japanese | Japanese participants received PF-07321332 250 mg and RTV 100 mg BID under fasted condition for 10 days. |
| FG012 | PART-3: rBA/FE Treatment Sequence 1 | PF-07321332 250 mg (Suspension), Fasted=>PF-07321332 250 mg (Tablet), Fasted=>PF-07321332 250 mg (Tablet), Fed Participants received a single dose of PF-07321332 250 mg (suspension) under fasted condition in period 1, PF-07321332 250 mg (tablet) under fasted condition in period 2, and PF-07321332 250 mg (tablet) under fed condition in period 3. There was a washout interval of at least 2 days between dosing in each period. |
| FG013 | PART-3: rBA/FE Treatment Sequence 2 | PF-07321332 250 mg (Tablet), Fasted=>PF-07321332 250 mg (Tablet), Fed=>PF-07321332 250 mg (Suspension), Fasted Participants received a single dose of PF-07321332 250 mg (tablet) under fasted condition in period 1, PF-07321332 250 mg (tablet) under fed condition in period 2, and PF-07321332 250 mg (suspension) under fasted condition in period 3. There was a washout interval of at least 2 days between dosing in each period. |
| FG014 | PART-3: rBA/FE Treatment Sequence 3 | PF-07321332 250 mg (Tablet), Fed=>PF-07321332 250 mg (Suspension), Fasted=>PF-07321332 250 mg (Tablet), Fasted Participants received a single dose of PF-07321332 250 mg (tablet) under fed condition in period 1, PF-07321332 250 mg (suspension) under fasted condition in period 2, and PF-07321332 250 mg (tablet) under fasted condition in period 3. There was a washout interval of at least 2 days between dosing in each period. |
| FG015 | PART-4: M&E PF-07321332 300 mg (Suspension)/RTV 100 mg, Fasted | Participants received a single oral dose of PF-07321332 300 mg with RTV (4 doses of 100 mg at -12h, 0h, 12h, and 24h relative to PF-07321332) under fasted condition. |
| FG016 | PART-5: SE Placebo (Suspension)/RTV 100 mg=>PF-07321332 2250 mg (Suspension)/RTV 100 mg | In period 1, participants received placebo (3 split doses at 0, 2h, and 4h) with RTV (3 doses of 100 mg at -12h, 0h and 12h post-dose) approximately 2h after breakfast. In period 2, participants received PF-07321332 2250 mg (divided into 3 doses of 750 mg administered at 0, 2h, and 4h) with RTV (3 doses of 100 mg at -12h, 0h and 12h post-dose) approximately 2h after breakfast. There was a washout interval of ≥5 days between periods. |
| FG017 | PART-5: SE PF-07321332 2250 mg (Suspension)/RTV 100 mg=>Placebo (Suspension)/RTV 100 mg | In period 1, participants received PF-07321332 2250 mg (divided into 3 doses of 750 mg administered at 0, 2h, and 4h) with RTV (3 doses of 100 mg at -12h, 0h and 12h post-dose) approximately 2h after breakfast. In period 2, participants received placebo (3 split doses at 0, 2h, and 4h) with RTV (3 doses of 100 mg at -12h, 0h and 12h post-dose) approximately 2h after breakfast. There was a washout interval of ≥5 days between periods. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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The baseline analysis population included all participants enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | PART-1: SAD Treatment Sequence 1 | PF-07321332 150 mg (Suspension), Fasted=>PF-07321332 1500 mg (Suspension), Fasted=>Placebo (Suspension)/RTV 100 mg, Fasted Participants received a single dose of PF-07321332 150 mg under fasted condition in period 1, a single dose of PF-07321332 1500 mg under fasted condition in period 2, a single dose of placebo and a total of 3 doses of RTV 100 mg at -12h, 0h and 12h post-dose under fasted condition in period 3. There was a washout interval of ≥5 days between periods. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in PART-1: SAD | An Adverse Event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were those with initial onset or increasing in severity between the first dose of study intervention and up to 36 days after last dose of study intervention. A serious adverse event (SAE) 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 AEs and SAEs were determined by the investigator. | The analysis population included all participants who received at least 1 dose of study intervention. | Posted | Number | Participants | Post the single dose of study intervention till up to 36 days |
|
Post first dose till up to 45 days after the last dose of the study intervention, up to 57 days.
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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 | Placebo (Suspension), Fasted | Participants received a single dose of placebo under fasted condition at 0 h |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood thyroid stimulating hormone increased | Investigations | 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 | Jun 24, 2021 | Sep 8, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 25, 2021 | Sep 8, 2022 | SAP_001.pdf |
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| PF-07321332 Dose 2 |
| Drug |
PF-07321332 Dose 2 or Placebo |
|
| PF-07321332 Dose 3 | Drug | PF-07321332 Dose 3 or Placebo |
|
| PF-07321332 Dose 4 | Drug | PF-07321332 Dose 4 or Placebo |
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| PF-07321332 Dose 5 | Drug | PF-07321332 Dose 5 or Placebo |
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| PF-07321332 Dose 4 or Placebo (Fed) | Drug | PF-07321332 Dose 5 or Placebo with high fat meal |
|
| Baseline up to Day 4 of the final period |
| Number of Participants With TEAEs in PART-2:MAD | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were those with initial onset or increasing in severity between the first dose of study intervention and up to 36 days after last dose of study intervention. An SAE 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 AEs and SAEs were determined by the investigator. | Post first dose till up to 45 days after last dose of study intervention |
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs in PART-2: MAD | Vital signs (temperature, respiratory rate, PR, SBP, DBP) were obtained with participants following at least 5 minutes of supine rest. Categorical criteria were defined as DBP: value <50 mm Hg, increase >=20 mm Hg, or decrease >=20 mm Hg; PR: value <40 bpm or value >120 bpm; SBP: value <90 mm Hg, increase >=30 mm Hg, or decrease >=30 mm Hg. Clinical significance of vital signs was determined at the investigator's discretion. | Baseline up to Day 12 |
| Number of Participants With Laboratory Abnormalities in PART-2: MAD | Laboratory parameters included hematology, chemistry, urinalysis, and other (urine drug screening, SARS-CoV-2 RT-PCR, eGFR, pregnancy test [b-hCG], aPTT, PT-INR, fibrinogen, TSH, Free T4). The clinical significance of laboratory parameters was determined at the investigator's discretion. The analysis population included all participants who received at least 1 dose of the study intervention. | Baseline up to Day 12 |
| Area Under the Plasma Concentration-Time Profile From Time 0 to The Time of The Last Quantifiable Concentration (AUClast) of Tablet Formulation and Suspension in PART-3: rBA/FE | AUClast is area under the concentration-time profile from time 0 (pre-dose) to the time of the last quantifiable concentration. | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, and 48 hours post-dose |
| Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of Tablet Formulation and Suspension in PART-3: rBA/FE | AUCinf is area under the concentration-time profile from time 0 (pre-dose) extrapolated to infinite time. Natural log transformed AUCinf for PF-07321332 was analyzed to provide an estimate of the ratio of adjusted geometric means (Test [tablet] /Reference [suspension]) and 90% CI for the ratio. | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, and 48 hours post-dose |
| Maximum Plasma Concentration (Cmax) of Tablet Formulation and Suspension in PART-3: rBA/FE | Cmax is maximum plasma concentration. It was observed directly from data. Natural log transformed Cmax for PF-07321332 was analyzed to provide an estimate of the ratio of adjusted geometric means (Test [tablet] /Reference [suspension]) and 90% CI for the ratio. | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, and 48 hours post-dose |
| Total Percent Recovery of Drug-Related Material in Urine in PART-4: ME | Total recovery of drug-related material excreted in urine, expressed as a percent of total dose administered, measured by fluorine-19 nuclear magnetic resonance (19F-NMR). | Day 1 to Day 11 |
| Total Percent Recovery of Drug-Related Material in Feces in PART-4: ME | Total recovery of drug-related material excreted in feces, expressed as a percent of total dose administered, measured by 19F-NMR. | Day 1 to Day 11 |
| Total Percent Recovery of Drug-Related Material in Excreta (Urine and Feces Combined) in PART-4: ME | Total recovery of drug-related material excreted in urine and feces combined, expressed as a percent of total dose administered, measured by 19F-NMR. | Day 1 to Day 11 |
| Number of Participants With TEAEs in PART-5: SE | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were those with initial onset or increasing in severity between the first dose of study intervention and up to 36 days after last dose of study intervention. An SAE 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 AEs and SAEs were determined by the investigator. | Post first dose till up to 36 days after last dose of study intervention |
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs in PART-5: SE | Vital signs (temperature, respiratory rate, PR, SBP, DBP) were obtained with participants following at least 5 minutes of supine rest. Categorical criteria were defined as DBP: value <50 mm Hg, increase >=20 mm Hg, or decrease >=20 mm Hg; PR: value <40 bpm or value >120 bpm; SBP: value <90 mm Hg, increase >=30 mm Hg, or decrease >=30 mm Hg. Clinical significance of vital signs was determined at the investigator's discretion. | Baseline up to Day 5 of the final period |
| Number of Participants With Laboratory Abnormalities in PART-5: SE | Laboratory parameters included hematology, chemistry, urinalysis, and other (urine drug screening, SARS-CoV-2 RT-PCR, eGFR, pregnancy test [b-hCG], aPTT, PT-INR, fibrinogen, TSH, Free T4). The clinical significance of laboratory parameters was determined at the investigator's discretion. The analysis population included all participants who received at least 1 dose of the study intervention. | Baseline up to Day 5 of the final period |
Time to reach Cmax. |
| Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
| AUClast of Plasma PF-07321332 in PART-1: SAD | AUClast is area under the concentration-time profile from time 0 (pre-dose) to the time of the last quantifiable concentration. | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
| AUCinf of PF-07321332 in PART-1: SAD | AUCinf is area under the concentration-time profile from time 0 (pre-dose) extrapolated to infinite time. | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
| Dose Normalized Cmax (Cmax[dn]) of Plasma PF-07321332 in PART-1: SAD | Cmax is maximum plasma concentration. It was observed directly from data. Cmax(dn) = Cmax / dose. | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
| Dose Normalized AUCinf (AUCinf[dn]) of Plasma PF-07321332 in PART-1: SAD | AUCinf is area under the concentration-time profile from time 0 (pre-dose) extrapolated to infinite time. AUCinf(dn) = AUCinf/dose. | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
| Dose Normalized AUClast (AUClast[dn]) of Plasma PF-07321332 in PART-1: SAD | AUClast is area under the concentration-time profile from time 0 (pre-dose) to the time of the last quantifiable concentration. AUClast(dn) = AUClast /dose. | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
| Apparent Volume of Distribution (Vz/F) in PART-1: SAD | Vz/F = Dose/(AUCinf*kel), where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
| Apparent Clearance (CL/F) in PART-1: SAD | CL/F is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F = Dose/AUCinf. | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
| Terminal Half-Life (t1/2) of Plasma PF-07321332 in PART-1: SAD | t1/2 is the time measured for the plasma concentration of drug to decrease by one half of its initial concentration. | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
| Cmax of Plasma PF-07321332 in PART-2: MAD on Day 1, Day 5 and Day 10 | Cmax is maximum plasma concentration. It was observed directly from data. | Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose on Day 1, Day 5; and pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16 hours post-dose on Day 10. |
| Tmax of Plasma PF-07321332 in PART-2: MAD on Day 1, Day 5 and Day 10 | Time to reach Cmax. | Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose on Day 1, Day 5; and pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16 hours post-dose on Day 10. |
| Area Under the Plasma Concentration Time Profile From Time 0 to Time Tau (AUCtau) of Plasma PF-07321332 in PART-2: MAD on Day 1, Day 5 and Day 10 | AUCtau is area under the concentration-time profile from time 0 (pre-dose) to end of dosing interval, where dosing interval was 12 hours. | Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose on Day 1, Day 5; and pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16 hours post-dose on Day 10. |
| Cmax(dn) of Plasma PF-07321332 in PART-2: MAD on Day 1, Day 5 and Day 10 | Cmax is maximum plasma concentration. It was observed directly from data. Cmax(dn) = Cmax / dose. | Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose on Day 1, Day 5; and pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16 hours post-dose on Day 10. |
| Dose Normalized AUCtau (AUCtau[dn]) of Plasma PF-07321332 in PART-2: MAD on Day 1, Day 5 and Day 10 | AUCtau is area under the concentration-time profile from time 0 (pre-dose) to end of dosing interval, where dosing interval was 12 hours. AUCtau(dn) = AUCtau/dose. | Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose on Day 1, Day 5; and pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16 hours post-dose on Day 10. |
| Average Plasma Concentration Over the Dosing Interval (Cav) of Plasma PF-07321332 in PART-2: MAD on Day 5 and Day 10 | Cav is average plasma concentration over the dosing interval, where dosing interval was 12 hours. | Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose on Day 1, Day 5; and pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16 hours post-dose on Day 10. |
| Minimum Observed Concentration During the Dosing Interval (Cmin) of Plasma PF-07321332 in PART-2: MAD on Day 5 and Day 10 | Cmin is minimum observed concentration during the dosing interval, where dosing interval was 12 hours. | Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose on Day 1, Day 5; and pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16 hours post-dose on Day 10. |
| Observed Accumulation Ratio for AUCtau (Rac) Plasma PF-07321332 in PART-2: MAD on Day 5 and Day 10 | Rac was calculated as Day 5 or Day 10 AUCtau/Day 1 AUCtau. | Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose on Day 1, Day 5; and pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16 hours post-dose on Day 10. |
| Observed Accumulation Ratio for Cmax (Rac,Cmax) of Plasma PF-07321332 in PART-2: MAD on Day 5 and Day 10 | Rac,Cmax is Day 5 or Day 10 Cmax/Day 1 Cmax. | Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose on Day 1, Day 5; and pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16 hours post-dose on Day 10. |
| Peak-to-Trough Ratio (PTR) of Plasma PF-07321332 in PART-2: MAD on Day 5 and Day 10 | PTR is defined as peak-to-trough ratio. PTR = Cmax/Cmin. | Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose on Day 1, Day 5; and pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16 hours post-dose on Day 10. |
| CL/F of Plasma PF-07321332 in PART-2:MAD on Day 5 and Day 10 | CL/F is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F = Dose/AUCtau. | Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose on Day 1, Day 5; and pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16 hours post-dose on Day 10. |
| Vz/F of Plasma PF-07321332 in PART-2: MAD on Day 10 | Vz/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F = Dose/(AUCinf*kel), where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. | Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16 hours post-dose on Day 10. |
| t1/2 of of Plasma PF-07321332 in PART-2: MAD on Day 10 | t1/2 is the time measured for the plasma concentration of drug to decrease by one-half of its initial concentration. | Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16 hours post-dose on Day 10. |
| Amount Excreted in Urine as Unchanged Drug Over the Dosing Interval Tau (Aetau) in PART-2: MAD on Day 10 | Ae is the cumulative amount of drug recovered unchanged in urine during the dosing interval, where the dosing interval is 12 hours. Aetau is the sum of (urine volume × urine concentration) for each collection over the dosing interval. | Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16 hours post-dose on Day 10. |
| Percent of Dose Excreted in Urine as Unchanged Drug Over the Dosing Interval Tau (Aetau%) in PART-2: MAD on Day 10 | Aetau% is defined as percent of dose excreted in urine as unchanged drug over the dosing interval, where the dosing interval is 12 hours. Aetau% = Aetau / Dose * 100. | Pre-dose to 12 hours post-dose on Day 10 |
| Renal Clearance (CLr) in PART-2: MAD on Day 10 | CLr is defined as the renal clearance. CLr = Aetau / AUCtau, where the dosing interval was 12 hours. | Pre-dose to 12 hours post-dose on Day 10 |
| AUClast of Plasma PF-07321332 of Tablet Formulation Under Fed Condition and Fasted Condition in PART-3: rBA/FE | AUClast is area under the concentration-time profile from time 0 (pre-dose) to the time of the last quantifiable concentration. Natural log transformed AUClast for PF-07321332 was analyzed to provide an estimate of the ratio of adjusted geometric means (Test [tablet under fed condition] /Reference [tablet under fasted condition]) and 90% CI for the ratio. | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, and 48 hours post-dose |
| AUCinf of Plasma PF-07321332 of Tablet Formulation Under Fed Condition and Fasted Condition in PART-3: rBA/FE | AUCinf is area under the concentration-time profile from time 0 (pre-dose) extrapolated to infinite time. Natural log transformed AUCinf for PF-07321332 was analyzed to provide an estimate of the ratio of adjusted geometric means (Test [tablet under fed condition] /Reference [tablet under fasted condition]) and 90% CI for the ratio. | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, and 48 hours post-dose |
| Cmax of Plasma PF-07321332 of Tablet Formulation Under Fed Condition and Fasted Condition in PART-3: rBA/FE | Cmax is maximum plasma concentration. It was observed directly from data. Natural log transformed Cmax for PF-07321332 was analyzed to provide an estimate of the ratio of adjusted geometric means (Test [tablet under fed condition] /Reference [tablet under fasted condition]) and 90% CI for the ratio. | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, and 48 hours post-dose |
| Cmax(dn) of Plasma PF-07321332 in PART-3: rBA/FE | Cmax is maximum plasma concentration. It was observed directly from data. Cmax(dn) = Cmax / dose. | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, and 48 hours post-dose |
| Tmax of Plasma PF-07321332 in PART-3: rBA/FE | Time to reach Cmax. | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, and 48 hours post-dose |
| AUClast(dn) of Plasma PF-07321332 in PART-3: rBA/FE | AUClast is area under the concentration-time profile from time 0 (pre-dose) to the time of the last quantifiable concentration. AUClast(dn) = AUClast /dose. | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, and 48 hours post-dose |
| AUCinf(dn) of Plasma PF-07321332 in PART-3: rBA/FE | AUCinf is area under the concentration-time profile from time 0 (pre-dose) extrapolated to infinite time. AUCinf(dn) = AUCinf/dose. | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, and 48 hours post-dose |
| CL/F of Plasma PF-07321332 in PART-3: rBA/FE | CL/F is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F = Dose/AUCinf. | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, and 48 hours post-dose |
| Vz/F of Plasma PF-07321332 in PART-3: rBA/FE | Vz/F = Dose/(AUCinf*kel), where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, and 48 hours post-dose |
| t1/2 of Plasma PF-07321332 in PART-3: rBA/FE | t1/2 is the time measured for the plasma concentration of drug to decrease by one-half of its initial concentration. | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, and 48 hours post-dose |
| Number of Participants With TEAEs in PART-3: rBA/FE | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were those with initial onset or increasing in severity between the first dose of study intervention and up to 36 days after last dose of study intervention. An SAE 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 AEs and SAEs were determined by the investigator. | Post the single dose of study intervention till up to 36 days |
| Number of Participants With Laboratory Test Abnormalities in PART-3: rBA/FE | Laboratory parameters included hematology, chemistry, urinalysis, and other (urine drug screening, SARS-CoV-2 RT-PCR, eGFR, pregnancy test [b-hCG], aPTT, PT-INR, fibrinogen, TSH, Free T4). The clinical significance of laboratory parameters was determined at the investigator's discretion. The analysis population included all participants who received at least 1 dose of the study intervention. | Baseline up to Day 3 |
| Cmax of Plasma PF-07321332 in PART-4: ME | Cmax is maximum plasma concentration. It was observed directly from data. | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
| Tmax of Plasma PF-07321332 in PART-4: ME | Tmax is time to reach Cmax. | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
| AUClast of Plasma PF-07321332 in PART-4: ME | AUClast is area under the concentration-time profile from time 0 (pre-dose) to the time of the last quantifiable concentration. | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
| AUCinf of Plasma PF-07321332 in PART-4: ME | AUCinf is area under the concentration-time profile from time 0 (pre-dose) extrapolated to infinite time. | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
| CL/F of Plasma PF-07321332 in PART-4: ME | CL/F is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F = Dose/AUCinf. | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
| Vz/F of Plasma PF-07321332 in PART-4: ME | Vz/F = Dose/(AUCinf*kel), where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
| t1/2 of Plasma PF-07321332 in PART-4: ME | t1/2 is the time measured for the plasma concentration of drug to decrease by one-half of its initial concentration. | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
| Number of Participants With TEAEs in PART-4: ME | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were those with initial onset or increasing in severity between the first dose of study intervention and up to 36 days after last dose of study intervention. An SAE 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 AEs and SAEs were determined by the investigator. | Post the single dose of study intervention till up to 36 days |
| Number of Participants With Laboratory Abnormalities in PART-4: ME | Laboratory parameters included hematology, chemistry, urinalysis, and other (urine drug screening, SARS-CoV-2 RT-PCR, eGFR, pregnancy test [b-hCG], aPTT, PT-INR, fibrinogen, TSH, Free T4). The clinical significance of laboratory parameters was determined at the investigator's discretion. | Baseline up to Day 11 |
| Cmax of Plasma PF-07321332 in PART-5: SE | Cmax is maximum plasma concentration. It was observed directly from data. | Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96 hours post-dose |
| Tmax of Plasma PF-07321332 in PART-5: SE | Time to reach Cmax. | Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96 hours post-dose |
| AUClast of Plasma PF-07321332 in PART-5: SE | AUClast is area under the concentration-time profile from time 0 (pre-dose) to the time of the last quantifiable concentration. | Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96 hours post-dose |
| AUCinf of Plasma PF-07321332 in PART-5: SE | AUCinf is area under the concentration-time profile from time 0 (pre-dose) extrapolated to infinite time. | Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96 hours post-dose |
| t1/2 of Plasma PF-07321332 in PART-5: SE | t1/2 is the time measured for the plasma concentration of drug to decrease by one-half of its initial concentration. | Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96 hours post-dose |
| Brussels |
| Bruxelles-capitale, Région de |
| B-1070 |
| Belgium |
| Withdrawal by Subject |
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| BG001 | PART-1: SAD Treatment Sequence 2 | PF-07321332 150 mg (Suspension), Fasted=>Placebo (Suspension), Fasted=>PF-07321332 750 mg (Suspension)/RTV 100 mg, Fasted Participants received a single dose of PF-07321332 150 mg under fasted condition in period 1, a single dose of placebo under fasted condition in period 2, a single dose of PF-07321332 750 mg and a total of 3 doses of RTV 100 mg at -12h, 0h and 12h post-dose under fasted condition in period 3. There was a washout interval of ≥5 days between periods. |
| BG002 | PART-1:SAD Treatment Sequence 3 | Placebo (Suspension), Fasted=>PF-07321332 1500 mg (Suspension), Fasted=>PF-07321332 750 mg (suspension)/RTV 100 mg, Fasted Participants received a single dose of placebo under fasted condition in period 1, a single dose of PF-07321332 1500 mg under fasted condition in period 2, a single dose of PF-07321332 750 mg and a total of 3 doses of RTV 100 mg at -12 hour (h), 0h and 12h post-dose under fasted condition in period 3. There was a washout interval of ≥5 days between periods. |
| BG003 | PART-1: SAD Treatment Sequence 4 | PF-07321332 500 mg (Suspension), Fasted=>PF-07321332 250 mg (Suspension)/RTV 100 mg, Fasted=>PF-07321332 250 mg (Suspension)/RTV 100 mg, Fed Participants received a single dose of PF-07321332 500 mg under fasted condition in period 1, a single dose of PF-07321332 250 mg and a total of 3 doses of RTV 100 mg at -12h, 0h and 12h post-dose under fasted condition in period 2, a single dose of PF-07321332 250 mg and a total of 3 doses of RTV 100 mg at -12h, 0h and 12h post-dose under fed condition in period 3. There was a washout interval of ≥5 days between periods. |
| BG004 | PART-1: SAD Treatment Sequence 5 | PF-07321332 500 mg (Suspension), Fasted=>Placebo (Suspension)/RTV 100 mg, Fasted=>Placebo (Suspension)/RTV 100 mg, Fed Participants received a single dose of PF-07321332 500 mg under fasted condition in period 1, a single dose of placebo and a total of 3 doses of RTV 100 mg at -12h, 0h and 12h post-dose under fasted condition in period 2, a single dose of placebo and a total of 3 doses of RTV 100 mg at -12h, 0h and 12h post-dose under fed condition in period 3. There was a washout interval of ≥5 days between periods. |
| BG005 | PART-1: SAD Treatment Sequence 6 | Placebo (Suspension), Fasted=>PF-07321332 250 mg (Suspension)/RTV 100 mg, Fasted=>PF-07321332 250 mg (Suspension)/RTV 100 mg, Fed Participants received a single dose of placebo under fasted condition in period 1, a single dose of PF-07321332 250 mg and a total of 3 doses of RTV 100 mg at -12h, 0h and 12h post-dose under fasted condition in period 2, a single dose of PF-07321332 250 mg and a total of 3 doses of RTV 100 mg at -12h, 0h and 12h post-dose under fed condition in period 3. There was a washout interval of ≥5 days between periods. |
| BG006 | PART-2: MAD Placebo (Suspension)/RTV 100 mg Twice Daily (BID), Fasted | Participants received placebo and RTV 100 mg BID under fasted condition for 10 days. |
| BG007 | PART-2: MAD PF-07321332 (Suspension)/RTV 75/100 mg BID, Fasted | Participants received PF-07321332 75 mg and RTV 100 mg BID under fasted condition for 10 days. |
| BG008 | PART-2: MAD PF-07321332 (Suspension)/RTV 250/100 mg BID, Fasted | Participants received PF-07321332 250 mg and RTV 100 mg BID under fasted condition for 10 days. |
| BG009 | PART-2: MAD PF-07321332 (Suspension)/RTV 500/100 mg BID, Fasted | Participants received PF-07321332 500 mg and RTV 100 mg BID under fasted condition for 10 days. |
| BG010 | PART-2: MAD Placebo (Suspension)/RTV100 mg BID, Fasted, Japanese | Japanese participants received placebo and RTV 100 mg BID under fasted condition for 10 days. |
| BG011 | PART-2: MAD PF-07321332 (Suspension)/RTV 250/100 mg BID, Fasted, Japanese | Japanese participants received PF-07321332 250 mg and RTV 100 mg BID under fasted condition for 10 days. |
| BG012 | PART-3: rBA/FE Treatment Sequence 1 | PF-07321332 250 mg (Suspension), Fasted=>PF-07321332 250 mg (Tablet), Fasted=>PF-07321332 250 mg (Tablet), Fed Participants received a single dose of PF-07321332 250 mg (suspension) under fasted condition in period 1, PF-07321332 250 mg (tablet) under fasted condition in period 2, and PF-07321332 250 mg (tablet) under fed condition in period 3. There was a washout interval of at least 2 days between dosing in each period. |
| BG013 | PART-3: rBA/FE Treatment Sequence 2 | PF-07321332 250 mg (Tablet), Fasted=>PF-07321332 250 mg (Tablet), Fed=>PF-07321332 250 mg (Suspension), Fasted Participants received a single dose of PF-07321332 250 mg (tablet) under fasted condition in period 1, PF-07321332 250 mg (tablet) under fed condition in period 2, and PF-07321332 250 mg (suspension) under fasted condition in period 3. There was a washout interval of at least 2 days between dosing in each period. |
| BG014 | PART-3: rBA/FE Treatment Sequence 3 | PF-07321332 250 mg (Tablet), Fed=>PF-07321332 250 mg (Suspension), Fasted=>PF-07321332 250 mg (Tablet), Fasted Participants received a single dose of PF-07321332 250 mg (tablet) under fed condition in period 1, PF-07321332 250 mg (suspension) under fasted condition in period 2, and PF-07321332 250 mg (tablet) under fasted condition in period 3. There was a washout interval of at least 2 days between dosing in each period. |
| BG015 | PART-4: M&E PF-07321332 300 mg (Suspension)/RTV 100 mg, Fasted | Participants received a single oral dose of PF-07321332 300 mg with RTV (4 doses of 100 mg at -12h, 0h, 12h, and 24h relative to PF-07321332) under fasted condition. |
| BG016 | PART-5: SE Placebo (Suspension)/RTV 100 mg=>PF-07321332 2250 mg (Suspension)/RTV 100 mg | In period 1, participants received placebo (3 split doses at 0, 2h, and 4h) with RTV (3 doses of 100 mg at -12h, 0h and 12h post-dose) approximately 2h after breakfast. In period 2, participants received PF-07321332 2250 mg (divided into 3 doses of 750 mg administered at 0, 2h, and 4h) with RTV (3 doses of 100 mg at -12h, 0h and 12h post-dose) approximately 2h after breakfast. There was a washout interval of ≥5 days between periods. |
| BG017 | PART-5: SE PF-07321332 2250 mg (Suspension)/RTV 100 mg=>Placebo (Suspension)/RTV 100 mg | In period 1, participants received PF-07321332 2250 mg (divided into 3 doses of 750 mg administered at 0, 2h, and 4h) with RTV (3 doses of 100 mg at -12h, 0h and 12h post-dose) approximately 2h after breakfast. In period 2, participants received placebo (3 split doses at 0, 2h, and 4h) with RTV (3 doses of 100 mg at -12h, 0h and 12h post-dose) approximately 2h after breakfast. There was a washout interval of ≥5 days between periods. |
| BG018 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| OG000 | Placebo (Suspension), Fasted | Participants received a single dose of placebo under fasted condition at 0 h |
| OG001 | Placebo (Suspension)/RTV 100 mg, Fasted | Participants received a single dose of placebo at 0 h under fasted condition in combination with RTV 100 mg at -12, 0 and 12h |
| OG002 | Placebo (Suspension)/RTV 100 mg, Fed | Participants received a single dose of placebo at 0 h under fed condition in combination with RTV 100 mg at -12, 0 and 12h |
| OG003 | PF-07321332 150 mg (Suspension), Fasted | Participants received a single dose of PF-07321332 150 mg (suspension) alone at 0 h under fasted condition |
| OG004 | PF-07321332 500 mg (Suspension), Fasted | Participants received a single dose of PF-07321332 500 mg (suspension) alone at 0 h under fasted condition |
| OG005 | PF-07321332 1500 mg (Suspension), Fasted | Participants received a single dose of PF-07321332 1500 mg (suspension) alone at 0 h under fasted condition |
| OG006 | PF-07321332 250 mg (Suspension)/RTV 100 mg, Fasted | Participants received a single dose of PF-07321332 250 mg (suspension) at 0 h under fasted condition in combination with RTV 100 mg at -12, 0 and 12h |
| OG007 | PF-07321332 250 mg (Suspension)/RTV 100 mg, Fed | Participants received a single dose of PF-07321332 250 mg (suspension) at 0 h under fed condition in combination with RTV 100 mg at -12, 0 and 12h |
| OG008 | PF-07321332 750 mg (Suspension)/RTV 100 mg, Fasted | Participants received a single dose of PF-07321332 750 mg (suspension) at 0 h under fasted condition in combination with RTV 100 mg at -12, 0 and 12h |
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| Primary | Number of Participants With Clinically Significant Change From Baseline in Vital Signs in PART-1: SAD | Vital signs (temperature, respiratory rate, pulse rate [PR], systolic blood pressure [SBP], and diastolic blood pressure [DBP]) were obtained with participants following at least 5 minutes of supine rest. Categorical criteria were defined as DBP: value <50 millimeters of mercury (mm Hg), increase >=20 mm Hg, or decrease >=20 mm Hg; PR: value <40 beats per minute (bpm) or value >120 bpm; SBP: value <90 mm Hg, increase >=30 mm Hg, or decrease >=30 mm Hg. Clinical significance of vital signs was determined at the investigator's discretion. The analysis population included all participants who received at least 1 dose of study intervention and had at least 1 assessment undertaken post treatment. | The analysis population included all participants who received at least 1 dose of study intervention. | Posted | Number | Participants | Baseline up to Day 2 of the final period |
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| Primary | Number of Participants With Laboratory Abnormalities in PART-1: SAD | Laboratory parameters included hematology, chemistry, urinalysis, and other (urine drug screening, Severe Acute Respiratory Syndrome Coronavirus 2 [SARS-CoV-2] reverse transcription polymerase chain reaction [RT-PCR], estimated glomerular filtration rate [eGFR], pregnancy test [beta human chorionic gonadotropin [b-hCG]], activated partial thromboplastin time [aPTT], prothrombin time [PT] - international normalized ratio [INR], fibrinogen, thyroid stimulating hormone [TSH], Free thyroxine [T4]). The clinical significance of laboratory parameters was determined at the investigator's discretion. The analysis population included all participants who received at least 1 dose of the study intervention. | The analysis population included all participants who received at least 1 dose of study intervention. | Posted | Number | Participants | Baseline up to Day 4 of the final period |
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| Primary | Number of Participants With TEAEs in PART-2:MAD | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were those with initial onset or increasing in severity between the first dose of study intervention and up to 36 days after last dose of study intervention. An SAE 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 AEs and SAEs were determined by the investigator. | The analysis population included all participants who received at least 1 dose of study intervention. | Posted | Number | Participants | Post first dose till up to 45 days after last dose of study intervention |
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| Primary | Number of Participants With Clinically Significant Change From Baseline in Vital Signs in PART-2: MAD | Vital signs (temperature, respiratory rate, PR, SBP, DBP) were obtained with participants following at least 5 minutes of supine rest. Categorical criteria were defined as DBP: value <50 mm Hg, increase >=20 mm Hg, or decrease >=20 mm Hg; PR: value <40 bpm or value >120 bpm; SBP: value <90 mm Hg, increase >=30 mm Hg, or decrease >=30 mm Hg. Clinical significance of vital signs was determined at the investigator's discretion. | The analysis population included all participants who received at least 1 dose of study intervention and had at least 1 assessment undertaken post treatment. | Posted | Number | Participants | Baseline up to Day 12 |
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| Primary | Number of Participants With Laboratory Abnormalities in PART-2: MAD | Laboratory parameters included hematology, chemistry, urinalysis, and other (urine drug screening, SARS-CoV-2 RT-PCR, eGFR, pregnancy test [b-hCG], aPTT, PT-INR, fibrinogen, TSH, Free T4). The clinical significance of laboratory parameters was determined at the investigator's discretion. The analysis population included all participants who received at least 1 dose of the study intervention. | The analysis population included all participants who received at least 1 dose of study intervention. | Posted | Number | Participants | Baseline up to Day 12 |
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| Primary | Area Under the Plasma Concentration-Time Profile From Time 0 to The Time of The Last Quantifiable Concentration (AUClast) of Tablet Formulation and Suspension in PART-3: rBA/FE | AUClast is area under the concentration-time profile from time 0 (pre-dose) to the time of the last quantifiable concentration. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, and 48 hours post-dose |
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| Primary | Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of Tablet Formulation and Suspension in PART-3: rBA/FE | AUCinf is area under the concentration-time profile from time 0 (pre-dose) extrapolated to infinite time. Natural log transformed AUCinf for PF-07321332 was analyzed to provide an estimate of the ratio of adjusted geometric means (Test [tablet] /Reference [suspension]) and 90% CI for the ratio. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/ml | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, and 48 hours post-dose |
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| Primary | Maximum Plasma Concentration (Cmax) of Tablet Formulation and Suspension in PART-3: rBA/FE | Cmax is maximum plasma concentration. It was observed directly from data. Natural log transformed Cmax for PF-07321332 was analyzed to provide an estimate of the ratio of adjusted geometric means (Test [tablet] /Reference [suspension]) and 90% CI for the ratio. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, and 48 hours post-dose |
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| Primary | Total Percent Recovery of Drug-Related Material in Urine in PART-4: ME | Total recovery of drug-related material excreted in urine, expressed as a percent of total dose administered, measured by fluorine-19 nuclear magnetic resonance (19F-NMR). | The analysis population included all participants who received at least 1 dose of study intervention. | Posted | Mean | Standard Deviation | Percent of the dose | Day 1 to Day 11 |
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| Primary | Total Percent Recovery of Drug-Related Material in Feces in PART-4: ME | Total recovery of drug-related material excreted in feces, expressed as a percent of total dose administered, measured by 19F-NMR. | The analysis population included all participants who received at least 1 dose of study intervention. | Posted | Mean | Standard Deviation | Percent of the dose | Day 1 to Day 11 |
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| Primary | Total Percent Recovery of Drug-Related Material in Excreta (Urine and Feces Combined) in PART-4: ME | Total recovery of drug-related material excreted in urine and feces combined, expressed as a percent of total dose administered, measured by 19F-NMR. | The analysis population included all participants who received at least 1 dose of study intervention. | Posted | Mean | Standard Deviation | Percent of the dose | Day 1 to Day 11 |
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| Primary | Number of Participants With TEAEs in PART-5: SE | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were those with initial onset or increasing in severity between the first dose of study intervention and up to 36 days after last dose of study intervention. An SAE 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 AEs and SAEs were determined by the investigator. | The analysis population included all participants who received at least 1 dose of study intervention. | Posted | Number | Participants | Post first dose till up to 36 days after last dose of study intervention |
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| Primary | Number of Participants With Clinically Significant Change From Baseline in Vital Signs in PART-5: SE | Vital signs (temperature, respiratory rate, PR, SBP, DBP) were obtained with participants following at least 5 minutes of supine rest. Categorical criteria were defined as DBP: value <50 mm Hg, increase >=20 mm Hg, or decrease >=20 mm Hg; PR: value <40 bpm or value >120 bpm; SBP: value <90 mm Hg, increase >=30 mm Hg, or decrease >=30 mm Hg. Clinical significance of vital signs was determined at the investigator's discretion. | The analysis population included all participants who received at least 1 dose of study intervention. | Posted | Number | Participants | Baseline up to Day 5 of the final period |
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| Primary | Number of Participants With Laboratory Abnormalities in PART-5: SE | Laboratory parameters included hematology, chemistry, urinalysis, and other (urine drug screening, SARS-CoV-2 RT-PCR, eGFR, pregnancy test [b-hCG], aPTT, PT-INR, fibrinogen, TSH, Free T4). The clinical significance of laboratory parameters was determined at the investigator's discretion. The analysis population included all participants who received at least 1 dose of the study intervention. | The analysis population included all participants who received at least 1 dose of study intervention. | Posted | Number | Participants | Baseline up to Day 5 of the final period |
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| Secondary | Cmax of Plasma PF-07321332 in PART-1: SAD | Cmax is maximum plasma concentration. It was observed directly from data. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
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| Secondary | Time for Cmax (Tmax) of Plasma PF-07321332 in PART-1: SAD | Time to reach Cmax. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Median | Full Range | hr | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
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| Secondary | AUClast of Plasma PF-07321332 in PART-1: SAD | AUClast is area under the concentration-time profile from time 0 (pre-dose) to the time of the last quantifiable concentration. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
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| Secondary | AUCinf of PF-07321332 in PART-1: SAD | AUCinf is area under the concentration-time profile from time 0 (pre-dose) extrapolated to infinite time. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
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| Secondary | Dose Normalized Cmax (Cmax[dn]) of Plasma PF-07321332 in PART-1: SAD | Cmax is maximum plasma concentration. It was observed directly from data. Cmax(dn) = Cmax / dose. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL/mg | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
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| Secondary | Dose Normalized AUCinf (AUCinf[dn]) of Plasma PF-07321332 in PART-1: SAD | AUCinf is area under the concentration-time profile from time 0 (pre-dose) extrapolated to infinite time. AUCinf(dn) = AUCinf/dose. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL/mg | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
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| Secondary | Dose Normalized AUClast (AUClast[dn]) of Plasma PF-07321332 in PART-1: SAD | AUClast is area under the concentration-time profile from time 0 (pre-dose) to the time of the last quantifiable concentration. AUClast(dn) = AUClast /dose. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL/mg | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
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| Secondary | Apparent Volume of Distribution (Vz/F) in PART-1: SAD | Vz/F = Dose/(AUCinf*kel), where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
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| Secondary | Apparent Clearance (CL/F) in PART-1: SAD | CL/F is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F = Dose/AUCinf. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | liter/hour (L/hr) | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
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| Secondary | Terminal Half-Life (t1/2) of Plasma PF-07321332 in PART-1: SAD | t1/2 is the time measured for the plasma concentration of drug to decrease by one half of its initial concentration. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Mean | Standard Deviation | hr | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
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| Secondary | Cmax of Plasma PF-07321332 in PART-2: MAD on Day 1, Day 5 and Day 10 | Cmax is maximum plasma concentration. It was observed directly from data. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose on Day 1, Day 5; and pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16 hours post-dose on Day 10. |
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| Secondary | Tmax of Plasma PF-07321332 in PART-2: MAD on Day 1, Day 5 and Day 10 | Time to reach Cmax. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Median | Full Range | hr | Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose on Day 1, Day 5; and pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16 hours post-dose on Day 10. |
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| Secondary | Area Under the Plasma Concentration Time Profile From Time 0 to Time Tau (AUCtau) of Plasma PF-07321332 in PART-2: MAD on Day 1, Day 5 and Day 10 | AUCtau is area under the concentration-time profile from time 0 (pre-dose) to end of dosing interval, where dosing interval was 12 hours. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose on Day 1, Day 5; and pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16 hours post-dose on Day 10. |
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| Secondary | Cmax(dn) of Plasma PF-07321332 in PART-2: MAD on Day 1, Day 5 and Day 10 | Cmax is maximum plasma concentration. It was observed directly from data. Cmax(dn) = Cmax / dose. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL/mg | Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose on Day 1, Day 5; and pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16 hours post-dose on Day 10. |
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| Secondary | Dose Normalized AUCtau (AUCtau[dn]) of Plasma PF-07321332 in PART-2: MAD on Day 1, Day 5 and Day 10 | AUCtau is area under the concentration-time profile from time 0 (pre-dose) to end of dosing interval, where dosing interval was 12 hours. AUCtau(dn) = AUCtau/dose. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL/mg | Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose on Day 1, Day 5; and pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16 hours post-dose on Day 10. |
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| Secondary | Average Plasma Concentration Over the Dosing Interval (Cav) of Plasma PF-07321332 in PART-2: MAD on Day 5 and Day 10 | Cav is average plasma concentration over the dosing interval, where dosing interval was 12 hours. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose on Day 1, Day 5; and pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16 hours post-dose on Day 10. |
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| Secondary | Minimum Observed Concentration During the Dosing Interval (Cmin) of Plasma PF-07321332 in PART-2: MAD on Day 5 and Day 10 | Cmin is minimum observed concentration during the dosing interval, where dosing interval was 12 hours. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose on Day 1, Day 5; and pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16 hours post-dose on Day 10. |
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| Secondary | Observed Accumulation Ratio for AUCtau (Rac) Plasma PF-07321332 in PART-2: MAD on Day 5 and Day 10 | Rac was calculated as Day 5 or Day 10 AUCtau/Day 1 AUCtau. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio | Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose on Day 1, Day 5; and pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16 hours post-dose on Day 10. |
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| Secondary | Observed Accumulation Ratio for Cmax (Rac,Cmax) of Plasma PF-07321332 in PART-2: MAD on Day 5 and Day 10 | Rac,Cmax is Day 5 or Day 10 Cmax/Day 1 Cmax. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio | Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose on Day 1, Day 5; and pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16 hours post-dose on Day 10. |
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| Secondary | Peak-to-Trough Ratio (PTR) of Plasma PF-07321332 in PART-2: MAD on Day 5 and Day 10 | PTR is defined as peak-to-trough ratio. PTR = Cmax/Cmin. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio | Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose on Day 1, Day 5; and pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16 hours post-dose on Day 10. |
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| Secondary | CL/F of Plasma PF-07321332 in PART-2:MAD on Day 5 and Day 10 | CL/F is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F = Dose/AUCtau. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/hr | Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose on Day 1, Day 5; and pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16 hours post-dose on Day 10. |
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| Secondary | Vz/F of Plasma PF-07321332 in PART-2: MAD on Day 10 | Vz/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F = Dose/(AUCinf*kel), where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter | Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16 hours post-dose on Day 10. |
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| Secondary | t1/2 of of Plasma PF-07321332 in PART-2: MAD on Day 10 | t1/2 is the time measured for the plasma concentration of drug to decrease by one-half of its initial concentration. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Mean | Standard Deviation | hr | Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16 hours post-dose on Day 10. |
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| Secondary | Amount Excreted in Urine as Unchanged Drug Over the Dosing Interval Tau (Aetau) in PART-2: MAD on Day 10 | Ae is the cumulative amount of drug recovered unchanged in urine during the dosing interval, where the dosing interval is 12 hours. Aetau is the sum of (urine volume × urine concentration) for each collection over the dosing interval. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | mg | Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16 hours post-dose on Day 10. |
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| Secondary | Percent of Dose Excreted in Urine as Unchanged Drug Over the Dosing Interval Tau (Aetau%) in PART-2: MAD on Day 10 | Aetau% is defined as percent of dose excreted in urine as unchanged drug over the dosing interval, where the dosing interval is 12 hours. Aetau% = Aetau / Dose * 100. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | percentage of dose | Pre-dose to 12 hours post-dose on Day 10 |
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| Secondary | Renal Clearance (CLr) in PART-2: MAD on Day 10 | CLr is defined as the renal clearance. CLr = Aetau / AUCtau, where the dosing interval was 12 hours. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/hr | Pre-dose to 12 hours post-dose on Day 10 |
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| Secondary | AUClast of Plasma PF-07321332 of Tablet Formulation Under Fed Condition and Fasted Condition in PART-3: rBA/FE | AUClast is area under the concentration-time profile from time 0 (pre-dose) to the time of the last quantifiable concentration. Natural log transformed AUClast for PF-07321332 was analyzed to provide an estimate of the ratio of adjusted geometric means (Test [tablet under fed condition] /Reference [tablet under fasted condition]) and 90% CI for the ratio. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, and 48 hours post-dose |
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| Secondary | AUCinf of Plasma PF-07321332 of Tablet Formulation Under Fed Condition and Fasted Condition in PART-3: rBA/FE | AUCinf is area under the concentration-time profile from time 0 (pre-dose) extrapolated to infinite time. Natural log transformed AUCinf for PF-07321332 was analyzed to provide an estimate of the ratio of adjusted geometric means (Test [tablet under fed condition] /Reference [tablet under fasted condition]) and 90% CI for the ratio. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, and 48 hours post-dose |
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| Secondary | Cmax of Plasma PF-07321332 of Tablet Formulation Under Fed Condition and Fasted Condition in PART-3: rBA/FE | Cmax is maximum plasma concentration. It was observed directly from data. Natural log transformed Cmax for PF-07321332 was analyzed to provide an estimate of the ratio of adjusted geometric means (Test [tablet under fed condition] /Reference [tablet under fasted condition]) and 90% CI for the ratio. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, and 48 hours post-dose |
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| Secondary | Cmax(dn) of Plasma PF-07321332 in PART-3: rBA/FE | Cmax is maximum plasma concentration. It was observed directly from data. Cmax(dn) = Cmax / dose. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL/mg | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, and 48 hours post-dose |
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| Secondary | Tmax of Plasma PF-07321332 in PART-3: rBA/FE | Time to reach Cmax. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Median | Full Range | hr | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, and 48 hours post-dose |
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| Secondary | AUClast(dn) of Plasma PF-07321332 in PART-3: rBA/FE | AUClast is area under the concentration-time profile from time 0 (pre-dose) to the time of the last quantifiable concentration. AUClast(dn) = AUClast /dose. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL/mg | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, and 48 hours post-dose |
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| Secondary | AUCinf(dn) of Plasma PF-07321332 in PART-3: rBA/FE | AUCinf is area under the concentration-time profile from time 0 (pre-dose) extrapolated to infinite time. AUCinf(dn) = AUCinf/dose. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL/mg | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, and 48 hours post-dose |
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| Secondary | CL/F of Plasma PF-07321332 in PART-3: rBA/FE | CL/F is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F = Dose/AUCinf. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/hr | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, and 48 hours post-dose |
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| Secondary | Vz/F of Plasma PF-07321332 in PART-3: rBA/FE | Vz/F = Dose/(AUCinf*kel), where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, and 48 hours post-dose |
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| Secondary | t1/2 of Plasma PF-07321332 in PART-3: rBA/FE | t1/2 is the time measured for the plasma concentration of drug to decrease by one-half of its initial concentration. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Mean | Standard Deviation | hr | Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, and 48 hours post-dose |
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| Secondary | Number of Participants With TEAEs in PART-3: rBA/FE | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were those with initial onset or increasing in severity between the first dose of study intervention and up to 36 days after last dose of study intervention. An SAE 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 AEs and SAEs were determined by the investigator. | The analysis population included all participants who received at least 1 dose of study intervention. | Posted | Number | Participants | Post the single dose of study intervention till up to 36 days |
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| Secondary | Number of Participants With Laboratory Test Abnormalities in PART-3: rBA/FE | Laboratory parameters included hematology, chemistry, urinalysis, and other (urine drug screening, SARS-CoV-2 RT-PCR, eGFR, pregnancy test [b-hCG], aPTT, PT-INR, fibrinogen, TSH, Free T4). The clinical significance of laboratory parameters was determined at the investigator's discretion. The analysis population included all participants who received at least 1 dose of the study intervention. | The analysis population included all participants who received at least 1 dose of study intervention. | Posted | Number | Participants | Baseline up to Day 3 |
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| Secondary | Cmax of Plasma PF-07321332 in PART-4: ME | Cmax is maximum plasma concentration. It was observed directly from data. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
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| Secondary | Tmax of Plasma PF-07321332 in PART-4: ME | Tmax is time to reach Cmax. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Median | Full Range | hr | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
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| Secondary | AUClast of Plasma PF-07321332 in PART-4: ME | AUClast is area under the concentration-time profile from time 0 (pre-dose) to the time of the last quantifiable concentration. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
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| Secondary | AUCinf of Plasma PF-07321332 in PART-4: ME | AUCinf is area under the concentration-time profile from time 0 (pre-dose) extrapolated to infinite time. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
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| Secondary | CL/F of Plasma PF-07321332 in PART-4: ME | CL/F is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F = Dose/AUCinf. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/hr | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
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| Secondary | Vz/F of Plasma PF-07321332 in PART-4: ME | Vz/F = Dose/(AUCinf*kel), where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
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| Secondary | t1/2 of Plasma PF-07321332 in PART-4: ME | t1/2 is the time measured for the plasma concentration of drug to decrease by one-half of its initial concentration. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Mean | Standard Deviation | hr | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
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| Secondary | Number of Participants With TEAEs in PART-4: ME | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were those with initial onset or increasing in severity between the first dose of study intervention and up to 36 days after last dose of study intervention. An SAE 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 AEs and SAEs were determined by the investigator. | The analysis population included all participants who received at least 1 dose of study intervention. | Posted | Number | Participants | Post the single dose of study intervention till up to 36 days |
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| Secondary | Number of Participants With Laboratory Abnormalities in PART-4: ME | Laboratory parameters included hematology, chemistry, urinalysis, and other (urine drug screening, SARS-CoV-2 RT-PCR, eGFR, pregnancy test [b-hCG], aPTT, PT-INR, fibrinogen, TSH, Free T4). The clinical significance of laboratory parameters was determined at the investigator's discretion. | The analysis population included all participants who received at least 1 dose of study intervention. | Posted | Number | Participants | Baseline up to Day 11 |
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| Secondary | Cmax of Plasma PF-07321332 in PART-5: SE | Cmax is maximum plasma concentration. It was observed directly from data. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96 hours post-dose |
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| Secondary | Tmax of Plasma PF-07321332 in PART-5: SE | Time to reach Cmax. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Median | Full Range | hr | Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96 hours post-dose |
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| Secondary | AUClast of Plasma PF-07321332 in PART-5: SE | AUClast is area under the concentration-time profile from time 0 (pre-dose) to the time of the last quantifiable concentration. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/ml | Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96 hours post-dose |
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| Secondary | AUCinf of Plasma PF-07321332 in PART-5: SE | AUCinf is area under the concentration-time profile from time 0 (pre-dose) extrapolated to infinite time. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/ml | Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96 hours post-dose |
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| Secondary | t1/2 of Plasma PF-07321332 in PART-5: SE | t1/2 is the time measured for the plasma concentration of drug to decrease by one-half of its initial concentration. | The analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. | Posted | Mean | Standard Deviation | hr | Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96 hours post-dose |
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| 0 |
| 6 |
| 0 |
| 6 |
| 2 |
| 6 |
| EG001 | Placebo (Suspension)/RTV 100 mg, Fasted | Participants received a single dose of placebo at 0 h under fasted condition in combination with RTV 100 mg at -12, 0 and 12h | 0 | 4 | 0 | 4 | 1 | 4 |
| EG002 | Placebo (Suspension)/RTV 100 mg, Fed | Participants received a single dose of placebo at 0 h under fed condition in combination with RTV 100 mg at -12, 0 and 12h | 0 | 2 | 0 | 2 | 1 | 2 |
| EG003 | PF-07321332 150 mg (Suspension), Fasted | Participants received a single dose of PF-07321332 150 mg (suspension) alone at 0 h under fasted condition | 0 | 4 | 0 | 4 | 0 | 4 |
| EG004 | PF-07321332 500 mg (Suspension), Fasted | Participants received a single dose of PF-07321332 500 mg (suspension) alone at 0 h under fasted condition | 0 | 4 | 0 | 4 | 1 | 4 |
| EG005 | PF-07321332 1500 mg (Suspension), Fasted | Participants received a single dose of PF-07321332 1500 mg (suspension) alone at 0 h under fasted condition | 0 | 4 | 0 | 4 | 1 | 4 |
| EG006 | PF-07321332 250 mg (Suspension)/RTV 100 mg, Fasted | Participants received a single dose of PF-07321332 250 mg (suspension) at 0 h under fasted condition in combination with RTV 100 mg at -12, 0 and 12h | 0 | 4 | 0 | 4 | 1 | 4 |
| EG007 | PF-07321332 250 mg (Suspension)/RTV 100 mg, Fed | Participants received a single dose of PF-07321332 250 mg (suspension) at 0 h under fed condition in combination with RTV 100 mg at -12, 0 and 12h | 0 | 4 | 0 | 4 | 0 | 4 |
| EG008 | PF-07321332 750 mg (Suspension)/RTV 100 mg, Fasted | Participants received a single dose of PF-07321332 750 mg (suspension) at 0 h under fasted condition in combination with RTV 100 mg at -12, 0 and 12h | 0 | 4 | 0 | 4 | 0 | 4 |
| EG009 | Placebo (Suspension)/RTV 100 mg BID, Fasted | Participants received placebo (suspension)/RTV 100 mg BID for 10 days under fasted condition | 0 | 8 | 0 | 8 | 4 | 8 |
| EG010 | PF-07321332 (Suspension)/RTV 75/100 mg BID, Fasted | Participants received PF-07321332/RTV 75/100 mg BID for 10 days under fasted condition | 0 | 4 | 0 | 4 | 3 | 4 |
| EG011 | PF-07321332 (Suspension)/RTV 250/100 mg BID, Fasted | Participants received PF-07321332 (suspension)/RTV 250/100 mg BID for 10 days under fasted condition | 0 | 4 | 0 | 4 | 3 | 4 |
| EG012 | PF-07321332 (Suspension)/RTV 500/100 mg BID, Fasted | Participants received PF-07321332 (suspension)/RTV 500/100 mg BID for 10 days under fasted condition | 0 | 7 | 0 | 7 | 4 | 7 |
| EG013 | Placebo (Suspension)/RTV 100 mg BID, Fasted, Japanese | Japanese participants received placebo (suspension)/RTV 100 mg BID for 10 days under fasted condition | 0 | 2 | 0 | 2 | 2 | 2 |
| EG014 | PF-07321332 (Suspension)/RTV 250/100 mg BID, Fasted, Japanese | Japanese participants received PF-07321332 (suspension)/RTV 250/100 mg BID for 10 days under fasted condition | 0 | 4 | 0 | 4 | 4 | 4 |
| EG015 | PF-07321332 250 mg (Suspension), Fasted | Participants received a single dose of PF-07321332 250 mg (suspension) under fasted condition | 0 | 12 | 0 | 12 | 3 | 12 |
| EG016 | PF-07321332 250 mg (Tablet), Fasted | Participants received a single dose of PF-07321332 250 mg (tablet) under fasted condition | 0 | 12 | 0 | 12 | 3 | 12 |
| EG017 | PF-07321332 250 mg (Tablet), Fed | Participants received a single dose of PF-07321332 250 mg (tablet) under fed condition | 0 | 12 | 0 | 12 | 1 | 12 |
| EG018 | PF-07321332 300 mg (Suspension)/RTV 100 mg, Fasted | Participants received a single oral dose of PF-07321332 300 mg with RTV (4 doses of 100 mg at -12, 0, 12, and 24 hours relative to PF-07321332) | 0 | 6 | 0 | 6 | 1 | 6 |
| EG019 | Placebo (Suspension)/RTV 100 mg | Participants received placebo with RTV (3 doses of 100 mg at -12, 0, and 12 hours relative to placebo) | 0 | 10 | 0 | 10 | 3 | 10 |
| EG020 | PF-07321332 2250 mg (Suspension)/RTV 100 mg | PF-07321332 2250 mg was administered as 3 split doses of 750 mg at 0, 2h and 4h, with RTV (3 doses of 100 mg at -12, 0 and 12 hours relative to PF-07321332). | 0 | 10 | 0 | 10 | 3 | 10 |
| SARS-CoV-2 test positive | Investigations | 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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| Tremor | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Balance disorder | Nervous system 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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| Presyncope | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Hypertonia | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Photopsia | Eye disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Abdominal pain upper | 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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| 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 sounds abnormal | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Gingival bleeding | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Abdominal pain | 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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| 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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| Acne | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue 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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| Nasopharyngitis | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA v24.0 | Non-systematic Assessment |
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| Procedural dizziness | Injury, poisoning and procedural complications | MedDRA v24.0 | Non-systematic Assessment |
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| Vaccination complication | Injury, poisoning and procedural complications | MedDRA v24.0 | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Early satiety | 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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| Medical device site irritation | General disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Vessel puncture site haemorrhage | General disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Puncture site pain | General disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Chest discomfort | 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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| Application site erythema | General disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Application site pruritus | General disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Seasonal allergy | Immune system disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Sleep disorder | Psychiatric disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Initial insomnia | Psychiatric disorders | MedDRA v24.0 | Non-systematic Assessment |
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Not provided
Not provided
Not provided
| SBP decrease >=30 mmHg |
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| DBP decrease >=20 mmHg |
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| Participants with treatment-related TEAEs |
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| Participants with all-causality SAEs |
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| Participants with severe AEs |
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| Participants discontinued from study due to AEs |
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| Discontinued study drug due to AE, study continued |
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| Dose reduced/temporary discontinuation due to AEs |
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| SBP decrease >=30 mmHg |
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| DBP value <50 mmHg |
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| PR value <40 bpm |
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| Title | Measurements |
|---|---|
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| Participants with all-causality SAEs |
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| Participants with severe AEs |
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| Participants discontinued from study due to AEs |
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| Discontinued study drug due to AE, study continued |
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| Dose reduced/temporary discontinuation due to AEs |
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| Day 5 |
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| Day 10 |
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| Day 5 |
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| Day 10 |
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| Day 5 |
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| Day 10 |
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| Day 5 |
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| Day 10 |
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| Day 5 |
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| Day 10 |
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| Day 10 |
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| Day 10 |
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| Day 10 |
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| Day 10 |
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| Day 10 |
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| Day 10 |
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| Participants with all-causality SAEs |
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| Participants with severe AEs |
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| Participants discontinued from study due to AEs |
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| Discontinued study drug due to AE, study continued |
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| Dose reduced/temporary discontinuation due to AEs |
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| Title | Measurements |
|---|---|
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| Participants with severe AEs |
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| Participants discontinued from study due to AEs |
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| Discontinued study drug due to AE, study continued |
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| Dose reduced/temporary discontinuation due to AEs |
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