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The purpose of the study is to investigate the effects of multiple oral doses of sisunatovir on QTc Interval.
This study is seeking participants who:
All participants will remain in the study clinic for 4 days for each treatment, for safety review, laboratory collections, and to assess how the study medicine affects QTc intervals.
All participants selected in the study will be required to go through a screening period up to 28 days. A screening period is the time during which a few participants are examined to see whether they are fit for the study. During this period, the participant's medical history and past and current medications will be reviewed. A series of tests will also be performed to see if they are good to be selected for the study. If the participant meets all required criteria and are interested in continuing, the participant will be brought into the study clinic to stay overnight for 4 days for each treatment. On day 4, the participant will be discharged. About 28 to 35 days after discharge following the final treatment, the participant will be contacted for a follow up visit either in person or by telephone. This is to check up on how the participant is doing and to conclude the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | 6 capsules of sisunatovir administered Q12 hours for 5 doses |
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| Treatment B | Placebo Comparator | 6 capsules of placebo administered Q12 hours for 5 doses |
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| Treatment C | Active Comparator | 6 capsules of placebo administered Q12 hours for 4 doses, followed by a single tablet of moxifloxacin |
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| Treatment D | Experimental | 7 capsules of sisunatovir administered Q12 hours for 5 doses |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sisunatovir | Drug | 6 capsules administered Q12 hours for 5 doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Placebo-Adjusted Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) at Expected Maximum Concentration (Cmax) on Day 3 for Sisunatovir | The relationship between sisunatovir plasma concentration and change from baseline in Fridericia's heart-rate corrected QT interval were analyzed using a model-based concentration-QTc analysis consistent with the Scientific White Paper on Concentration-QT Modeling. Baseline was defined as the mean of the 3 averages of the triplicate electrocardiogram (ECG) measurements taken before dosing on Day 1 within each period. Mean and CI statistics were based on the individual (within subject) corrected differences between sisunatovir and placebo exposures. | Baseline, Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events | 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 adverse event was considered a Treatment-Emergent Adverse Event (TEAE) if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time but before the end of the study were considered as TEAEs. |
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Inclusion Criteria: for healthy volunteers:
Body Mass Index (BMI) of 17.5 to 32 kg/m2, inclusive, and a total body weight >50 kg (110 lb).
Capable of giving signed informed consent.
At screening, no clinically relevant abnormalities identified by a detailed medical history, complete physical examination, including blood pressure (BP) and pulse rate measurement, standard 12-lead electrocardiogram (ECG) and clinical laboratory tests.
--Exclusion criteria for all participants:
Any condition or surgery possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection)
Those with increased risk if dosed with moxifloxacin
Self-reported history or risk factors for QT prolongation or torsades de pointes, congenital deafness, family history of cardiac arrest or suggest death, and family history of long QT syndrome
Positive human immunodeficiency virus (HIV) antibodies
Positive drug or alcohol test
Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest. If BP is ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility-estimated glomerular filtration rate (GFR) <60 mL/min/1.73m2 at screening
Standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, QTcF >450 ms, complete LBBB, signs of an acute or indeterminate- age myocardial infarction, ST-T interval changes suggestive of myocardial ischemia, second- or third- degree AV block, or serious bradyarrhythmias or tachyarrhythmias). If the uncorrected QT interval is >450 ms, this interval should be rate-corrected using the Fridericia method only and the resulting QTcF should be used for decision making and reporting. If QTcF exceeds 450 ms, or QRS exceeds 120 ms, the ECG should be repeated twice and the average of the 3 QTcF or QRS values used to determine the participant's eligibility. Participants with an average QTc interval >450 milliseconds (ms) will not be allowed to participate in the study. Computer-interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding a participant.
GFR <60 mL/min/1.73m2 based on CKD-EPI equation
AST or ALT level ≥1.5 x upper limit normal (ULN)
Gamma-GT> 1.2 x ULN
Alkaline phosphatase > 1.2 x ULN
Total bilirubin level ≥1.5 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN
History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1 ounce (30 mL) of 40% spirit, or 3 ounces (90 mL) of wine).
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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 |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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This study was conducted at a single site in the United States. A total of 43 participants were assigned in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sisunatovir 300 mg Followed by (=>) Placebo + Moxifloxacin 400mg => Placebo | Healthy participants administered 5 doses of sisunatovir 300 milligram (mg) capsule orally every 12 hours (Q12) over 3 days in a fed condition in Period 1. Followed by 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 2. Followed by 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 3. There was washout period of minimum 7 days between doses. |
| FG001 | Sisunatovir 300 mg => Placebo => Placebo + Moxifloxacin 400 mg | Healthy participants administered 5 doses of sisunatovir 300 mg capsule orally every Q12 over 3 days in a fed condition in Period 1. Followed by 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 2. Followed by 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 3. There was washout period of minimum 7 days between doses. |
| FG002 | Sisunatovir 350 mg => Placebo + Moxifloxacin 400 mg => Placebo | Healthy participants administered 5 doses of sisunatovir 350 mg capsule orally every Q12 over 3 days in a fed condition in Period 1. Followed by 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 2. Followed by 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 3. There was washout period of minimum 7 days between doses. |
| FG003 | Sisunatovir 350 mg => Placebo => Placebo + Moxifloxacin 400 mg | Healthy participants administered 5 doses of sisunatovir 350 mg capsule orally every Q12 over 3 days in a fed condition in Period 1. Followed by 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 2. Followed by 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 3. There was washout period of minimum 7 days between doses. |
| FG004 | Placebo + Moxifloxacin 400 mg => Sisunatovir 300 mg => Placebo | Healthy participants administered 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 1. Followed by 5 doses of sisunatovir 300 mg capsule orally every Q12 over 3 days in a fed condition in Period 2. Followed by 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 3. There was washout period of minimum 7 days between doses. |
| FG005 | Placebo + Moxifloxacin 400 mg => Sisunatovir 350 mg => Placebo | Healthy participants administered 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 1. Followed by 5 doses of sisunatovir 350 mg capsule orally every Q12 over 3 days in a fed condition in Period 2. Followed by 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 3. There was washout period of minimum 7 days between doses. |
| FG006 | Placebo + Moxifloxacin 400 mg => Placebo => Sisunatovir 300 mg | Healthy participants administered 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 1. Followed by 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 2. Followed by 5 doses of sisunatovir 300 mg capsule orally every Q12 over 3 days in a fed condition in Period 3. There was washout period of minimum 7 days between doses. |
| FG007 | Placebo + Moxifloxacin 400 mg => Placebo => Sisunatovir 350 mg | Healthy participants administered 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 1. Followed by 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 2. Followed by 5 doses of sisunatovir 350 mg capsule orally every Q12 over 3 days in a fed condition in Period 3. There was washout period of minimum 7 days between doses. |
| FG008 | Placebo => Sisunatovir 300 mg => Placebo + Moxifloxacin 400 mg | Healthy participants administered 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 1. Followed by 5 doses of sisunatovir 300 mg capsule orally every Q12 over 3 days in a fed condition in Period 2. Followed by 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 3. There was washout period of minimum 7 days between doses. |
| FG009 | Placebo => Sisunatovir 350 mg => Placebo + Moxifloxacin 400 mg | Healthy participants administered 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 1. Followed by 5 doses of sisunatovir 350 mg capsule orally every Q12 over 3 days in a fed condition in Period 2. Followed by 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 3. There was washout period of minimum 7 days between doses. |
| FG010 | Placebo => Placebo + Moxifloxacin 400 mg => Sisunatovir 300 mg | Healthy participants administered 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 1. Followed by 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 2. Followed by 5 doses of sisunatovir 300 mg capsule orally every Q12 over 3 days in a fed condition in Period 3. There was washout period of minimum 7 days between doses. |
| FG011 | Placebo => Placebo + Moxifloxacin 400 mg => Sisunatovir 350 mg | Healthy participants administered 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 1. Followed by 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 2. Followed by 5 doses of sisunatovir 350 mg capsule orally every Q12 over 3 days in a fed condition in Period 3. There was washout period of minimum 7 days between doses. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period- 1 (3 Days) |
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| Washout Period-1 (7 Days) |
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| Treatment Period- 2 (3 Days) |
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| Washout Period-2 (7 Days) |
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| Treatment Period- 3 (3 Days) |
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Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sisunatovir 300 mg Followed by (=>) Placebo + Moxifloxacin 400mg => Placebo | Healthy participants administered 5 doses of sisunatovir 300 milligram (mg) capsule orally every 12 hours (Q12) over 3 days in a fed condition in Period 1. Followed by 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 2. Followed by 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 3. There was washout period of minimum 7 days between doses. |
| 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, Continuous | Mean |
| 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 | Placebo-Adjusted Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) at Expected Maximum Concentration (Cmax) on Day 3 for Sisunatovir | The relationship between sisunatovir plasma concentration and change from baseline in Fridericia's heart-rate corrected QT interval were analyzed using a model-based concentration-QTc analysis consistent with the Scientific White Paper on Concentration-QT Modeling. Baseline was defined as the mean of the 3 averages of the triplicate electrocardiogram (ECG) measurements taken before dosing on Day 1 within each period. Mean and CI statistics were based on the individual (within subject) corrected differences between sisunatovir and placebo exposures. | The concentration QTc analysis set was defined as all participants randomized and treated with sisunatovir or placebo who had at least 1 pair of time-matched post-dose QT and sisunatovir plasma concentration values in at least 1 period of the study. For placebo treatment, the concentration was set to 0. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Mean | 90% Confidence Interval | Milli seconds (msec) | Baseline, Day 3 |
From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
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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 | Sisunatovir 300 mg | Healthy participants administered 5 doses of sisunatovir 300 mg capsule orally every Q12 over 3 days in a fed condition in any of the treatment periods. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA v26.1 | 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 | May 1, 2023 | Oct 22, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 5, 2023 | Oct 22, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000717948 | sisunatovir |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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Single Group, Crossover study
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Sisunatovir and placebo oral capsules will be prepared in the CRU by 2 operators, 1 of whom is an unblinded pharmacist. Sisunatovir and placebo will be administered in blinded fashion to the subject.
Moxifloxacin 400 mg tablets will be packaged in an open-label manner at the CRU in the individual dosing containers by 2 operators, 1 of whom is an appropriately qualified and experienced member of the study staff (eg, physician, nurse, physician's assistant, practitioner, or pharmacist).
| placebo | Drug | 6 capsules administered Q12 hours for 5 doses |
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| moxifloxacin | Drug | 6 capsules of placebo administered Q12 hours for 4 doses, followed by a single tablet of moxifloxacin |
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| sisunatovir | Drug | 7 capsules administered Q12 hours for 5 doses |
|
|
| From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks) |
| Number of Participants With Clinically Significant Changes in Electrocardiogram Parameters | Standard 12-lead ECGs were performed after the participant had rested quietly for at least 5 minutes in a supine position using an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, QTcF, and QRS complex. Clinical significance was determined based on investigator's discretion. Baseline of ECG parameters was defined as average of the triplicate ECGs collected at each time point before dosing on Day 1 within each period. | From Baseline up to Day 23 |
| Number of Participants Meeting Pre-defined Criteria for Vital Signs | Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured with the participant in a supine position after at least 5 minutes of rest. Vital signs were categorized as 1) supine diastolic blood pressure (DBP) minimum (min) less than (<)50 and maximum (max) increase greater than or equal to (>=) 20 millimeter of mercury (mmHg); 2) supine systolic blood pressure (SBP) max. decrease >=20 and min. <90 (mmHg). | From Baseline up to Day 23 |
| Number of Participants With Clinically Significant Changes in Laboratory Abnormalities | The clinical laboratory tests include hematology, chemistry, urinalysis and other tests. Following parameters were analyzed for laboratory assessments: Hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); Chemistry: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Albumin, Alkaline Phosphatase, Total Bilirubin, Creatinine, Uric Acid, Sodium, Potassium; Glucose(Fasting), Urea, Chloride, Bicarbonates, Total protein; Urinalysis: (decimal logarithm of reciprocal of hydrogen ion activity )[pH], Glucose, Protein, Blood, Ketones, Nitrites, Leukocyte esterase; Others tests: Pregnancy test, Urine drug screening, Covid-19 testing. Clinically significant laboratory abnormality findings were based on investigator discretion. | From Baseline up to Day 23 |
| Change From Baseline in QTcF of Moxifloxacin and Placebo at 3, 4 and 5 Hours Post-Dose of Day 3 | Change from baseline in QTcF intervals were analyzed using a MMRM model with sequence, period, treatment, time (post-dose timepoint) and treatment by time interaction as fixed effect, participants within sequence as a random effect and baseline QTcF as a covariate. A compound symmetry covariance matrix was fitted to the repeated times within participant and the Kenward-Roger approximation was used for estimating degrees of freedom. | Baseline, 3, 4 and 5 hours post-dose on Day 3 |
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| BG001 | Sisunatovir 300 mg => Placebo => Placebo + Moxifloxacin 400 mg | Healthy participants administered 5 doses of sisunatovir 300 mg capsule orally every Q12 over 3 days in a fed condition in Period 1. Followed by 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 2. Followed by 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 3. There was washout period of minimum 7 days between doses. |
| BG002 | Sisunatovir 350 mg => Placebo + Moxifloxacin 400 mg => Placebo | Healthy participants administered 5 doses of sisunatovir 350 mg capsule orally every Q12 over 3 days in a fed condition in Period 1. Followed by 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 2. Followed by 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 3. There was washout period of minimum 7 days between doses. |
| BG003 | Sisunatovir 350 mg => Placebo => Placebo + Moxifloxacin 400 mg | Healthy participants administered 5 doses of sisunatovir 350 mg capsule orally every Q12 over 3 days in a fed condition in Period 1. Followed by 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 2. Followed by 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 3. There was washout period of minimum 7 days between doses. |
| BG004 | Placebo => Placebo + Moxifloxacin 400 mg => Sisunatovir 300 mg | Healthy participants administered 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 1. Followed by 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 2. Followed by 5 doses of sisunatovir 300 mg capsule orally every Q12 over 3 days in a fed condition in Period 3. There was washout period of minimum 7 days between doses. |
| BG005 | Placebo => Placebo + Moxifloxacin 400 mg => Sisunatovir 350 mg | Healthy participants administered 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 1. Followed by 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 2. Followed by 5 doses of sisunatovir 350 mg capsule orally every Q12 over 3 days in a fed condition in Period 3. There was washout period of minimum 7 days between doses. |
| BG006 | Placebo => Sisunatovir 300 mg => Placebo + Moxifloxacin 400 mg | Healthy participants administered 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 1. Followed by 5 doses of sisunatovir 300 mg capsule orally every Q12 over 3 days in a fed condition in Period 2. Followed by 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 3. There was washout period of minimum 7 days between doses. |
| BG007 | Placebo => Sisunatovir 350 mg => Placebo + Moxifloxacin 400 mg | Healthy participants administered 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 1. Followed by 5 doses of sisunatovir 350 mg capsule orally every Q12 over 3 days in a fed condition in Period 2. Followed by 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 3. There was washout period of minimum 7 days between doses. |
| BG008 | Placebo + Moxifloxacin 400 mg => Sisunatovir 300 mg => Placebo | Healthy participants administered 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 1. Followed by 5 doses of sisunatovir 300 mg capsule orally every Q12 over 3 days in a fed condition in Period 2. Followed by 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 3. There was washout period of minimum 7 days between doses. |
| BG009 | Placebo + Moxifloxacin 400 mg => Sisunatovir 350 mg => Placebo | Healthy participants administered 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 1. Followed by 5 doses of sisunatovir 350 mg capsule orally every Q12 over 3 days in a fed condition in Period 2. Followed by 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 3. There was washout period of minimum 7 days between doses. |
| BG010 | Placebo + Moxifloxacin 400 mg => Placebo => Sisunatovir 300 mg | Healthy participants administered 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 1. Followed by 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 2. Followed by 5 doses of sisunatovir 300 mg capsule orally every Q12 over 3 days in a fed condition in Period 3. There was washout period of minimum 7 days between doses. |
| BG011 | Placebo + Moxifloxacin 400 mg => Placebo => Sisunatovir 350 mg | Healthy participants administered 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 1. Followed by 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 2. Followed by 5 doses of sisunatovir 350 mg capsule orally every Q12 over 3 days in a fed condition in Period 3. There was washout period of minimum 7 days between doses. |
| BG012 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | Sisunatovir 300 mg | Healthy participants administered 5 doses of sisunatovir 300 mg capsule orally every Q12 over 3 days in a fed condition in any of the treatment periods. |
| OG001 | Sisunatovir 350 mg | Healthy participants administered 5 doses of sisunatovir 350 mg capsule orally every Q12 over 3 days in a fed condition in any of the treatment periods. |
|
|
| Secondary | Number of Participants With Treatment Emergent Adverse Events | 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 adverse event was considered a Treatment-Emergent Adverse Event (TEAE) if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time but before the end of the study were considered as TEAEs. | Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks) |
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| Secondary | Number of Participants With Clinically Significant Changes in Electrocardiogram Parameters | Standard 12-lead ECGs were performed after the participant had rested quietly for at least 5 minutes in a supine position using an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, QTcF, and QRS complex. Clinical significance was determined based on investigator's discretion. Baseline of ECG parameters was defined as average of the triplicate ECGs collected at each time point before dosing on Day 1 within each period. | Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | From Baseline up to Day 23 |
|
|
|
| Secondary | Number of Participants Meeting Pre-defined Criteria for Vital Signs | Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured with the participant in a supine position after at least 5 minutes of rest. Vital signs were categorized as 1) supine diastolic blood pressure (DBP) minimum (min) less than (<)50 and maximum (max) increase greater than or equal to (>=) 20 millimeter of mercury (mmHg); 2) supine systolic blood pressure (SBP) max. decrease >=20 and min. <90 (mmHg). | Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | From Baseline up to Day 23 |
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| Secondary | Number of Participants With Clinically Significant Changes in Laboratory Abnormalities | The clinical laboratory tests include hematology, chemistry, urinalysis and other tests. Following parameters were analyzed for laboratory assessments: Hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); Chemistry: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Albumin, Alkaline Phosphatase, Total Bilirubin, Creatinine, Uric Acid, Sodium, Potassium; Glucose(Fasting), Urea, Chloride, Bicarbonates, Total protein; Urinalysis: (decimal logarithm of reciprocal of hydrogen ion activity )[pH], Glucose, Protein, Blood, Ketones, Nitrites, Leukocyte esterase; Others tests: Pregnancy test, Urine drug screening, Covid-19 testing. Clinically significant laboratory abnormality findings were based on investigator discretion. | Safety analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | From Baseline up to Day 23 |
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| Secondary | Change From Baseline in QTcF of Moxifloxacin and Placebo at 3, 4 and 5 Hours Post-Dose of Day 3 | Change from baseline in QTcF intervals were analyzed using a MMRM model with sequence, period, treatment, time (post-dose timepoint) and treatment by time interaction as fixed effect, participants within sequence as a random effect and baseline QTcF as a covariate. A compound symmetry covariance matrix was fitted to the repeated times within participant and the Kenward-Roger approximation was used for estimating degrees of freedom. | ECG analysis set included all participants who were randomized and treated who have at least 1 post-dose ECG measurement in at least 1 period. This was planned to be reported in moxifloxacin and placebo as pre-specified in protocol. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Least Squares Mean | 90% Confidence Interval | msec | Baseline, 3, 4 and 5 hours post-dose on Day 3 |
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|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 8 |
| 13 |
| EG001 | Sisunatovir 350 mg | Healthy participants administered 5 doses of sisunatovir 350 mg capsule orally every Q12 over 3 days in a fed condition in any of the treatment periods. | 0 | 29 | 0 | 29 | 8 | 29 |
| EG002 | Placebo | Healthy participants administered 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in any of the treatment periods. | 0 | 41 | 0 | 41 | 4 | 41 |
| EG003 | Placebo + Moxifloxacin 400 mg | Healthy participants administered 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in any of the treatment periods. | 0 | 39 | 0 | 39 | 7 | 39 |
| Constipation | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Skin laceration | Injury, poisoning and procedural complications | MedDRA v26.1 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Brain fog | Nervous system disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA v26.1 | Non-systematic Assessment |
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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.
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Supine diastolic blood pressure (mmHg) max. increase >=20 |
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| Supine systolic blood pressure (mmHg) max. decrease >=20 |
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| Supine systolic blood pressure (mmHg) min. <90 |
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| 5 hours post-dose |
|
| LS Mean difference |
| 11.35 |
| 2-Sided |
| 90 |
| 8.50 |
| 14.20 |
| Other |
| 5-hours post-dose | LS Mean difference | 8.35 | 90 | 5.51 | 11.20 | Other |