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This is a drug-drug interaction study to assess the effects of PF-07321332/ritonavir and ritonavir on the Pharmacokinetic (PK) of dabigatran in healthy volunteers. PK will be evaluated for PF-07321332 and ritonavir. Dabigatran is being utilized as a P-gp substrate
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Active Comparator | Dabigatran only |
|
| Treatment B | Experimental | PF-07321332/ritonavir + Dabigatran |
|
| Treatment C | Active Comparator | Ritonavir + Dabigatran |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dabigatran | Drug | A single dose of Dabigatran on Day 1 |
| |
| PF-07321332/ritonavir + Dabigatran |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Dabigatran (Total) PK Parameters (PF-07321332/Ritonavir Co-administered With Dabigatran [Treatment 2]): Maximum Plasma Concentration (Cmax) | Cmax was defined as maximum observed plasma concentration. | Treatment 1 Day 1 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose. Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose |
| Plasma Dabigatran (Total) PK Parameters (PF-07321332/Ritonavir Co-administered With Dabigatran [Treatment 2]): AUCinf | AUCinf was defined as the area under the plasma concentration-time curve from time 0 extrapolated to infinity | Treatment 1 Day 1 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose. Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose |
| Plasma Dabigatran (Total) PK Parameters (PF-07321332/Ritonavir Co-administered With Dabigatran [Treatment 2]): AUClast | AUClast was defined as area under the plasma concentration time curve from time 0 to the time of the last measurable concentration. | Treatment 1 Day 1 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose. Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Dabigatran (Total) PK Parameters (Ritonavir Co-administered With Dabigatran [Treatment 3]): Maximum Plasma Concentration (Cmax) | Cmax was defined as maximum observed plasma concentration | Treatment 1 Day 1 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose. Treatment 3 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose |
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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 |
|---|---|---|---|---|---|---|
| Research Centers of America ( Hollywood ) | Hollywood | Florida | 33024 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37354048 | Derived | Cox DS, Rehman M, Khan T, Ginman K, Salageanu J, LaBadie RR, Wan K, Damle B. Effects of nirmatrelvir/ritonavir on midazolam and dabigatran pharmacokinetics in healthy participants. Br J Clin Pharmacol. 2023 Nov;89(11):3352-3363. doi: 10.1111/bcp.15835. Epub 2023 Jul 12. | |
| 37231296 | Derived | Sagawa K, Lin J, Jaini R, Di L. Physiologically-Based Pharmacokinetic Modeling of PAXLOVID with First-Order Absorption Kinetics. Pharm Res. 2023 Aug;40(8):1927-1938. doi: 10.1007/s11095-023-03538-5. Epub 2023 May 25. |
| 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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A total of 24 participants were enrolled into the study, and 4 participants were assigned to each of the 6 sequences to receive following treatments:
Treatment 1: dabigatran 75 mg orally (PO) single dose Treatment 2: PF-07321332/ritonavir 300 mg/100 mg PO q12h for 2 days + dabigatran 75 mg PO single dose on Day 2 Treatment 3: ritonavir 100 mg PO q12h for 2 days + dabigatran 75 mg PO single dose on Day 2
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| ID | Title | Description |
|---|---|---|
| FG000 | Dabigatran 75mg=>PF-07321332 300mg+Ritonavir 100mg+Dabigatran 75mg=>Ritonavir 100mg+Dabigatran 75mg | For participants in Sequence 1: In Period 1, participants received Dabigatran orally as a 75 mg single dose followed by a 3-day washout.(Treatment 1) In Period 2, participants received PF-07321332/ritonavir 300 mg/100 mg every 12 hours (q12h) as a multiple dose over a period of 2 days. In the morning on Day 2, 75 mg of dabigatran was administered orally as a single dose, followed by a 3-day washout. (Treatment 2) In Period 3, participants received ritonavir 100 mg every 12 hours (q12h) as a multiple dose over a period of 2 days. In the morning on Day 2, 75 mg of dabigatran was administered orally as a single dose. (Treatment 3) |
| FG001 | Dabigatran 75mg=>Ritonavir 100mg+Dabigatran 75mg=>PF-07321332 300mg+Ritonavir 100mg+Dabigatran 75mg | For participants in Sequence 6: In Period 1, participants received Dabigatran orally as a 75 mg single dose followed by a 3-day washout. In Period 2, participants received ritonavir 100 mg every 12 hours (q12h) as a multiple dose over a period of 2 days. In the morning on Day 2, 75 mg of dabigatran was administered orally as a single dose. In Period 3, participants received PF-07321332/ritonavir 300 mg/100 mg q12h as a multiple dose over a period of 2 days. In the morning on Day 2, 75 mg of dabigatran was administered orally as a single dose. Treatment 2 was followed by a 3-day washout. |
| FG002 | PF-07321332 300mg+Ritonavir 100mg+Dabigatran 75mg=>Dabigatran 75mg=>Ritonavir 100mg+Dabigatran 75mg | For participants in Sequence 5: In Period 1, participants received PF-07321332/ritonavir 300 mg/100 mg q12h as a multiple dose over a period of 2 days. In the morning on Day 2, 75 mg of dabigatran was administered orally as a single dose. Treatment 2 was followed by a 3-day washout. In Period 2, participants received Dabigatran orally as a 75 mg single dose followed by a 3-day washout. In Period 3, participants received ritonavir 100 mg every 12 hours (q12h) as a multiple dose over a period of 2 days. In the morning on Day 2, 75 mg of dabigatran was administered orally as a single dose. |
| FG003 | PF-07321332 300mg+Ritonavir 100mg+Dabigatran 75mg=>Ritonavir 100mg+Dabigatran 75mg=>Dabigatran 75mg | For participants in Sequence 3: In Period 1, Participants received PF-07321332/ritonavir 300 mg/100 mg q12h as a multiple dose over a period of 2 days. In the morning on Day 2, 75 mg of dabigatran was administered orally as a single dose. Treatment 2 was followed by a 3-day washout. In Period 2, Participants received ritonavir 100 mg every 12 hours (q12h) as a multiple dose over a period of 2 days. In the morning on Day 2, 75 mg of dabigatran was administered orally as a single dose. In Period 3, Participants received Dabigatran orally as a 75 mg single dose followed by a 3-day washout. |
| FG004 | Ritonavir 100mg+Dabigatran 75mg=>Dabigatran 75mg=>PF-07321332 300mg+Ritonavir 100mg+Dabigatran 75mg | For participants in Sequence 2: In Period 1, Participants received ritonavir 100 mg every 12 hours (q12h) as a multiple dose over a period of 2 days. In the morning on Day 2, 75 mg of dabigatran was administered orally as a single dose. In Period 2, Participants received Dabigatran orally as a 75 mg single dose followed by a 3-day washout. In Period 3, Participants received PF-07321332/ritonavir 300 mg/100 mg q12h as a multiple dose over a period of 2 days. In the morning on Day 2, 75 mg of dabigatran was administered orally as a single dose. Treatment 2 was followed by a 3-day washout. |
| FG005 | Ritonavir 100mg+Dabigatran 75mg=>PF-07321332 300mg+Ritonavir 100mg+Dabigatran 75mg=>Dabigatran 75mg | For participants in Sequence 4: In Period 1, Participants received ritonavir 100 mg every 12 hours (q12h) as a multiple dose over a period of 2 days. In the morning on Day 2, 75 mg of dabigatran was administered orally as a single dose. In Period 2, Participants received PF-07321332/ritonavir 300 mg/100 mg q12h as a multiple dose over a period of 2 days. In the morning on Day 2, 75 mg of dabigatran was administered orally as a single dose. Treatment 2 was followed by a 3-day washout. In Period 3, Participants received Dabigatran orally as a 75 mg single dose followed by a 3-day washout. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Period 2 |
| |||||||||||||
| Period 3 |
|
All participants who were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Enrolled Set | Enrolled set is defined as all participants legally authorized representative's, agreement to participate in this study following completion of the informed consent process and screening. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Plasma Dabigatran (Total) PK Parameters (PF-07321332/Ritonavir Co-administered With Dabigatran [Treatment 2]): Maximum Plasma Concentration (Cmax) | Cmax was defined as maximum observed plasma concentration. | All participants assigned to investigational product and treated who have at least 1 concentration measured. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Treatment 1 Day 1 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose. Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose |
|
From Study Day 1 up to Study Day 48
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
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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 | Treatment 1: Dabigatran 75 mg | Dabigatran was administered orally as a 75 mg single dose followed by a 3-day washout. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA v24.1 | 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 | Aug 3, 2021 | Oct 18, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 30, 2021 | Oct 18, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| C000718217 | nirmatrelvir |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
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This is a Phase1, open-label,3-treatment, 6-sequence, 3-period crossover study to estimate the effect of PF-07321332/ritonavir and ritonavir on the Pharmacokinetics of dabigatran in healthy participants
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| Drug |
PF-07321332/ritonavir twice daily (BID) for Days 1 and 2 Single dose of Dabigatran on Day 2 |
|
| Ritonavir + Dabigatran | Drug | Ritonavir BID on Days 1 and 2 Single dose of Dabigatran on Day 2 |
|
| Plasma Dabigatran (Total) PK Parameters (Ritonavir Co-administered With Dabigatran [Treatment 3]): AUCinf | AUCinf was defined as area under the plasma concentration-time curve from time 0 extrapolated to infinity | Treatment 1 Day 1 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose. Treatment 3 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose |
| Plasma Dabigatran (Total) PK Parameters (Ritonavir Co-administered With Dabigatran [Treatment 3]): AUClast | AUClast was defined as area under the plasma concentration time curve from time 0 to the time of the last measurable concentration. | Treatment 1 Day 1 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose. Treatment 3 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs , and TEAEs Leading to Participant Discontinuation From Study | 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. An serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. | From Pre-dose on Day 1 to Day 48 |
| Number of Participants With Laboratory Test Abnormality (Without Regard to Baseline Abnormality) | To determine if there are any clinically significant laboratory abnormalities, the haematological, clinical chemistry (serum) and urinalysis safety tests were assessed against the criteria specified in the sponsor reporting standards. Tests including Ery. Mean Corpuscular Hemoglobin, Eosinophils, Activated Partial Thromboplastin Time, Bilirubin, Fibrinogen, URINE Hemoglobin, Nitrite, and Leukocyte Esterase tests. | From pre-dose on Day 1 to Day 3 |
| Number of Participants With Vital Signs of Potential Clinical Concern | Single supine blood pressure and pulse rate tests were assessed against the criteria specified in the sponsor reporting standards. | From pre-dose on Day 1 to Day 3 |
| Number of Participants With ECG Values of Potential Clinical Concern | QT interval, QTc, PR, RR, QRS and heart rate tests were assessed against the criteria specified in the sponsor reporting standards. | From pre-dose on Day 1 to Day 3 |
| Plasma Dabigatran (Total) PK Parameters (PF-07321332/Ritonavir Co-administered With Dabigatran [Treatment 2]): Time to First Occurrence of Cmax (Tmax) | Tmax was defined as time to first occurrence of Cmax | Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose |
| Plasma Dabigatran (Total) PK Parameters (Ritonavir Co-administered With Dabigatran [Treatment 3]): Tmax | Tmax was defined as time to first occurrence of Cmax. | Treatment 3 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose |
| Plasma Dabigatran (Total) PK Parameters (PF-07321332/Ritonavir Co-administered With Dabigatran [Treatment 2]): Terminal Half-life (t½) | t½ was defined as terminal half-life of Dabigatran (Total) PK Parameters (PF-07321332/ritonavir co-administered with dabigatran. | Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose |
| Plasma Dabigatran (Total) PK Parameters (Ritonavir Co-administered With Dabigatran [Treatment 3]): t½ | t½ was defined as terminal half-life of Dabigatran (Total). | Treatment 3 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose |
| Plasma PF-07321332 PK Parameters: Cmax | Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12 hours post-dose |
| Plasma PF-07321332 PK Parameters: AUCtau | AUCtau was defined as area under the plasma concentration-time profile from time zero to time tau (τ) the dosing interval, where tau=12 hours for twice daily (BID) dosing. | Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12 hours post-dose |
| Plasma PF-07321332 PK Parameters: t½ | t½ was defined as terminal half-life of PF-07321332. | Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12 hours post-dose |
| Plasma PF-07321332 PK Parameters: Tmax | Tmax was defined as time to first occurrence of Cmax. | Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12 hours post-dose |
| Plasma PF-07321332 PK Parameters: CL/F | CL/F was defined as apparent clearance of drug from plasma. | Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12 hours post-dose |
| Plasma PF-07321332 PK Parameters: Vz/F | Vz/F was defined as apparent volume of distribution. | Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12 hours post-dose |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
PF-07321332/ritonavir 300 mg/100 mg every 12 hours (q12h) was administered as a multiple dose over a period of 2 days. In the morning on Treatment 2 Day 2, 75 mg of dabigatran was administered orally as a single dose. |
|
|
|
| Primary | Plasma Dabigatran (Total) PK Parameters (PF-07321332/Ritonavir Co-administered With Dabigatran [Treatment 2]): AUCinf | AUCinf was defined as the area under the plasma concentration-time curve from time 0 extrapolated to infinity | All participants assigned to investigational product and treated who have at least 1 concentration measured. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Treatment 1 Day 1 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose. Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose |
|
|
|
|
| Primary | Plasma Dabigatran (Total) PK Parameters (PF-07321332/Ritonavir Co-administered With Dabigatran [Treatment 2]): AUClast | AUClast was defined as area under the plasma concentration time curve from time 0 to the time of the last measurable concentration. | All participants assigned to investigational product and treated who have at least 1 concentration measured. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Treatment 1 Day 1 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose. Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose |
|
|
|
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| Secondary | Plasma Dabigatran (Total) PK Parameters (Ritonavir Co-administered With Dabigatran [Treatment 3]): Maximum Plasma Concentration (Cmax) | Cmax was defined as maximum observed plasma concentration | All participants assigned to investigational product and treated who have at least 1 concentration measured. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Treatment 1 Day 1 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose. Treatment 3 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose |
|
|
|
|
| Secondary | Plasma Dabigatran (Total) PK Parameters (Ritonavir Co-administered With Dabigatran [Treatment 3]): AUCinf | AUCinf was defined as area under the plasma concentration-time curve from time 0 extrapolated to infinity | All participants assigned to investigational product and treated who have at least 1 concentration measured. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Treatment 1 Day 1 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose. Treatment 3 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose |
|
|
|
|
| Secondary | Plasma Dabigatran (Total) PK Parameters (Ritonavir Co-administered With Dabigatran [Treatment 3]): AUClast | AUClast was defined as area under the plasma concentration time curve from time 0 to the time of the last measurable concentration. | All participants assigned to investigational product and treated who have at least 1 concentration measured. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Treatment 1 Day 1 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose. Treatment 3 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose |
|
|
|
|
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs , and TEAEs Leading to Participant Discontinuation From Study | 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. An serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. | All participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From Pre-dose on Day 1 to Day 48 |
|
|
|
| Secondary | Number of Participants With Laboratory Test Abnormality (Without Regard to Baseline Abnormality) | To determine if there are any clinically significant laboratory abnormalities, the haematological, clinical chemistry (serum) and urinalysis safety tests were assessed against the criteria specified in the sponsor reporting standards. Tests including Ery. Mean Corpuscular Hemoglobin, Eosinophils, Activated Partial Thromboplastin Time, Bilirubin, Fibrinogen, URINE Hemoglobin, Nitrite, and Leukocyte Esterase tests. | All participants with at least one observation of the given laboratory test while on study treatment or during lag time. | Posted | Count of Participants | Participants | From pre-dose on Day 1 to Day 3 |
|
|
|
| Secondary | Number of Participants With Vital Signs of Potential Clinical Concern | Single supine blood pressure and pulse rate tests were assessed against the criteria specified in the sponsor reporting standards. | All participants evaluated against criteria. | Posted | Count of Participants | Participants | From pre-dose on Day 1 to Day 3 |
|
|
|
| Secondary | Number of Participants With ECG Values of Potential Clinical Concern | QT interval, QTc, PR, RR, QRS and heart rate tests were assessed against the criteria specified in the sponsor reporting standards. | All participants evaluated against criteria. | Posted | Count of Participants | Participants | From pre-dose on Day 1 to Day 3 |
|
|
|
| Secondary | Plasma Dabigatran (Total) PK Parameters (PF-07321332/Ritonavir Co-administered With Dabigatran [Treatment 2]): Time to First Occurrence of Cmax (Tmax) | Tmax was defined as time to first occurrence of Cmax | All participants assigned to investigational product and treated who have at least 1 concentration measured. | Posted | Median | Full Range | hours | Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose |
|
|
|
| Secondary | Plasma Dabigatran (Total) PK Parameters (Ritonavir Co-administered With Dabigatran [Treatment 3]): Tmax | Tmax was defined as time to first occurrence of Cmax. | All participants assigned to investigational product and treated who have at least 1 concentration measured. | Posted | Median | Full Range | hours | Treatment 3 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose |
|
|
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| Secondary | Plasma Dabigatran (Total) PK Parameters (PF-07321332/Ritonavir Co-administered With Dabigatran [Treatment 2]): Terminal Half-life (t½) | t½ was defined as terminal half-life of Dabigatran (Total) PK Parameters (PF-07321332/ritonavir co-administered with dabigatran. | All participants assigned to investigational product and treated who have at least 1 concentration measured. | Posted | Mean | Standard Deviation | hours | Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose |
|
|
|
| Secondary | Plasma Dabigatran (Total) PK Parameters (Ritonavir Co-administered With Dabigatran [Treatment 3]): t½ | t½ was defined as terminal half-life of Dabigatran (Total). | All participants assigned to investigational product and treated who have at least 1 concentration measured. | Posted | Mean | Standard Deviation | hours | Treatment 3 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose |
|
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| Secondary | Plasma PF-07321332 PK Parameters: Cmax | All participants assigned to investigational product and treated who have at least 1 concentration measured. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12 hours post-dose |
|
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| Secondary | Plasma PF-07321332 PK Parameters: AUCtau | AUCtau was defined as area under the plasma concentration-time profile from time zero to time tau (τ) the dosing interval, where tau=12 hours for twice daily (BID) dosing. | All participants assigned to investigational product and treated who have at least 1 concentration measured. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12 hours post-dose |
|
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| Secondary | Plasma PF-07321332 PK Parameters: t½ | t½ was defined as terminal half-life of PF-07321332. | All participants assigned to investigational product and treated who have at least 1 concentration measured. | Posted | Mean | Standard Deviation | hours | Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12 hours post-dose |
|
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| Secondary | Plasma PF-07321332 PK Parameters: Tmax | Tmax was defined as time to first occurrence of Cmax. | All participants assigned to investigational product and treated who have at least 1 concentration measured. | Posted | Mean | Full Range | hours | Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12 hours post-dose |
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| Secondary | Plasma PF-07321332 PK Parameters: CL/F | CL/F was defined as apparent clearance of drug from plasma. | All participants assigned to investigational product and treated who have at least 1 concentration measured. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/hr | Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12 hours post-dose |
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|
| Secondary | Plasma PF-07321332 PK Parameters: Vz/F | Vz/F was defined as apparent volume of distribution. | All participants assigned to investigational product and treated who have at least 1 concentration measured. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters | Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12 hours post-dose |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Treatment 2: PF-07321332 300 mg + Ritonavir 100 mg + Dabigatran 75 mg | PF-07321332/ritonavir 300 mg/100 mg q12h was administered as a multiple dose over a period of 2 days. In the morning on Day 2, 75 mg of dabigatran was administered orally as a single dose. | 0 | 24 | 0 | 24 | 1 | 24 |
| EG002 | Treatment 3: Ritonavir 100 mg + Dabigatran 75 mg | ritonavir 100 mg q12h was administered as a multiple dose over a period of 2 days. In the morning on Day 2, 75 mg of dabigatran was administered orally as a single dose. | 0 | 24 | 0 | 24 | 2 | 24 |
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| Title | Measurements |
|---|---|
|
| All-Causality SAEs |
|
| Treatment-Related SAEs |
|
| All-Causality AEs leading to discontinuation from study |
|
| Treatment-Related AEs leading to discontinuation from study |
|
| Eosinophils (10^3/mm^3) > 1.2x ULN |
|
|
| Activated Partial Thromboplastin Time (sec) > 1.1x ULN |
|
|
| Bilirubin (mg/dL) > 1.5x ULN |
|
|
| Fibrinogen (mg/dL) > 1.25x Baseline |
|
|
| URINE Hemoglobin ≥ 1 |
|
|
| Nitrite ≥ 1 |
|
|
| Leukocyte Esterase ≥ 1 |
|
|
| Systolic Blood Pressure Change ≥ 30 mmHg increase |
|
|
| Systolic Blood Pressure Change ≥ 30 mmHg decrease |
|
|
| Diastolic Blood Pressure Value < 50 mmHg |
|
|
| Diastolic Blood Pressure Change ≥ 20 mmHg increase |
|
|
| Diastolic Blood Pressure Change ≥ 20 mmHg decrease |
|
|
| Pulse Rate Value < 40 bpm |
|
|
| Pulse Rate Value > 120 bpm |
|
|
| PR Interval not Otherwise Specified %Change ≥ 25/50% |
|
|
| QRS Interval not Otherwise Specified Value ≥ 140 MSEC |
|
|
| QRS Interval not Otherwise Specified %Change ≥ 50% |
|
|
| QTCF not Otherwise Specified 450 MSEC ≤ Value < 480 MSEC |
|
|
| QTCF not Otherwise Specified 480 MSEC ≤ Value < 500 MSEC |
|
|
| QTCF not Otherwise Specified Value ≥ 500 MSEC |
|
|
| QTCF not Otherwise Specified 30 MSEC ≤ Change < 60 MSEC |
|
|
| QTCF not Otherwise Specified Change ≥ 60 MSEC |
|
|