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The purpose of the study is to learn about:
This information is being collected to support further clinical development as well as medicine registration in China.
This study is seeking for participants who:
About 12 participants will receive sisunatovir. Four capsules (strength=50 milligrams, 200 milligrams in total) of Sisunatovir will be given on Day 1 on empty stomach. This will be followed by 8 capsules of sisunatovir with 12 hours gap in between four capsules from Days 4 to 7. The participants will have to take 4 capsules of sisunatovir in the morning of 8th day with a meal.
The total time of participants will be in the study is about 71 days. This includes the screening visit to the Follow-up contact. In screening visit, participants will be tested to see if they are fit to take part in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | This only arm will be given as a single dose on Day 1 in a fasted state followed by repeated twice daily doses (200 mg BID, Q12 hours) from Days 4-7 plus 1 morning dose on Day 8 in a fed state |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sisunatovir | Drug | Will be given as a single dose on Day 1 in a fasted state followed by repeated twice daily doses (200 mg BID, Q12 hours) from Days 4-7 plus 1 morning dose on Day 8 in a fed state |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Sisunatovir on Day 1 | Cmax was defined as maximum observed plasma concentration. Cmax was observed directly from data. | 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72 hours post dose on Day1 |
| Maximum Observed Plasma Concentration (Cmax) of Sisunatovir on Day 4 | Cmax was defined as maximum observed plasma concentration. | 0, 1, 2, 3, 4, 5, 6, 8, 10, 12 hours post dose on Day 4 |
| Maximum Observed Plasma Concentration (Cmax) of Sisunatovir on Day 8 | Cmax was defined as maximum observed plasma concentration. | 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72 hours post dose on Day 8 |
| Area Under the Plasma Concentration-time Profile From Time Zero to Time 12 Hours (AUC12) of Sisunatovir on Day 1 | AUC12 was defined as area under the concentration-time curve from time zero to 12 hours. | 0, 1, 2, 3, 4, 5, 6, 8, 10, 12 hours post dose on Day1 |
| Area Under the Plasma Concentration-time Profile From Time Zero to Time 12 Hours (AUC12) of Sisunatovir on Day 4 | AUC12 was defined as area under the concentration-time curve from time zero to 12 hours. | 0, 1, 2, 3, 4, 5, 6, 8, 10, 12 hours post dose on Day 4 |
| Area Under the Plasma Concentration-time Profile From Time Zero to Time 12 Hours (AUC12) of Sisunatovir on Day 8 | AUC12 was defined as area under the concentration-time curve from time zero to 12 hours. | 0, 1, 2, 3, 4, 5, 6, 8, 10, 12 hours post dose on Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Cmax (Tmax) on Day 1, Day 4 and Day 8 | Tmax was defined as time to reach Cmax. | 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72 hours post dose on Day1, and Day 8. 0, 1, 2, 3, 4, 5, 6, 8, 10, 12 hours post dose on Day 4. |
| Terminal Elimination Half-life (t½) on Day 1 and Day 8 |
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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 |
|---|---|---|---|---|---|---|
| Huashan Hospital, Fudan University | Shanghai | Shanghai Municipality | 200040 | China | ||
| Huashan Hospital |
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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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Follow-up occurred via telephone contact and must occur 28 to 35 days after administration of the last dose of study intervention.
Twelve participants were enrolled and treated in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sisunatovir 200 mg | Participants received a single oral dose of sisunatovir 200 mg on Day 1 in a fasted state followed by repeated twice daily doses (200 mg BID, every 12 hours [Q12 hours]) from Days 4-7 plus 1 morning dose on Day 8 in a fed state. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period (Day -1 to Day 11) |
| ||||||||||||||||
| FOLLOW-UP |
|
The baseline analysis population was defined as all participants enrolled and who took at least 1 dose of study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sisunatovir 200 mg | Participants received a single oral dose of sisunatovir 200 mg on Day 1 in a fasted state followed by repeated twice daily doses (200 mg BID, every 12 hours [Q12 hours]) from Days 4-7 plus 1 morning dose on Day 8 in a fed state. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Maximum Observed Plasma Concentration (Cmax) of Sisunatovir on Day 1 | Cmax was defined as maximum observed plasma concentration. Cmax was observed directly from data. | Analysis population included all participants who take at least 1 dose of study intervention and in whom at least 1 plasma concentration value is reported. One participant had emesis on Day 1 and therefore was excluded from the summaries. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72 hours post dose on Day1 |
|
From the first dose (Day 1) up to 35 days after the last dose (Day 8) of study intervention (up to 43 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 | Sisunatovir 200 mg | Participants received a single oral dose of sisunatovir 200 mg on Day 1 in a fasted state followed by repeated twice daily doses (200 mg BID, every 12 hours [Q12 hours]) from Days 4-7 plus 1 morning dose on Day 8 in a fed state. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | 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 | Jun 9, 2023 | Nov 24, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 8, 2023 | Nov 24, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C000717948 | sisunatovir |
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single-arm to investigate PK, safety and tolerability of 200 mg sisunatovir given as a single dose on Day 1 in a fasted state followed by repeated twice daily doses (200 mg BID, Q12 hours) from Days 4-7 plus 1 morning dose on Day 8 in a fed state in Chinese healthy participants.
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| Area Under the Plasma Concentration-time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of Sisunatovir on Day1 | AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. | 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72 hours post dose on Day1 |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) on Day1 | AUCinf was defined as area under the concentration-time curve from time 0 to infinity. | 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72 hours post dose on Day1 |
t½ was defined as terminal elimination half-life. |
| 0, 1, 2, 3, 4, 5, 6, 8, 10, 12,14, 24, 48, 72 hours post dose on Day1, and Day 8 |
| Accumulation Ratio for Sisunatovir (Rac) | Rac is defined as: Observed accumulation ratio for AUCtau. Accumulation ratio on AUCtau = AUC12 (Day 8) /AUC12 (Day 4) | 0, 1, 2, 3, 4, 5, 6, 8, 10, 12 hours post dose on Day 4 and Day 8 |
| Accumulation Ratio on Cmax for Sisunatovir (Rac, Cmax) | Accumulation ratio on Cmax =Cmax (Day 8) /Cmax (Day 4) | 0, 1, 2, 3, 4, 5, 6, 8, 10, 12 hours post dose on Day 4 and 0, 1, 2, 3, 4, 5, 6, 8, 10, 12,14, 24, 48, 72 hours post dose on Day 8 |
| Number of Participants With All-Causality and Treatment-Related Treatment-emergent Adverse Events (TEAEs) | An AE is any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship with the study intervention. SAE is defined as one of the following: is fatal or life threatening; results in persistent or significant disability/incapacity; constitutes a congenital anomaly/birth defect; is medically significant; requires inpatient hospitalization or prolongation of existing hospitalization. Treatment-emergent AE is defined as an AE with onset date occurring during the on-treatment period. AEs include all SAEs and non-SAEs. | From the first dose (Day 1) up to 35 days after the last dose (Day 8) of study intervention (up to 43 days) |
| Number of Participants With Vital Signs Meeting the Pre-specified Criteria | Blood pressure (BP) and pulse rate were obtained with participant following at least a 5-minute rest in a supine position. Clinical significance of vital signs was determined at the investigator's discretion. | Baseline up to Day 11 (11 days) |
| Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, platelet, neutrophils, eosinophils, monocytes, basophils, lymphocytes, leukocytes); clinical chemistry (alanine aminotransferase, albumin, alkaline phosphatase, bilirubin, calcium, carbon dioxide combining power, chloride, creatinine, cystatin C, GFR CKD-EPI serum creatinine 2021, gamma glutamyl transferase, glucose, potassium, sodium, urate, urea). urinalysis (Bilirubin, Glucose, Hemoglobin, Ketones, Leukocyte Esterase, Nitrite, Protein, Urobilinogen, pH).0 indicates no participants with abnormalities of all above lab examination. | Baseline up to Day 11 (11 days) |
| Number of Participants With Electrocardiogram (ECG) Abnormalities | Criteria for ECG abnormalities: maximum PR interval >=300 milliseconds (msec) and maximum increase PR interval increase from baseline (IFB): percent change (Pctchg) >=25 percent (%) for baseline value of >200 msec and Pctchg>=50% for baseline value of <=200 msec for PR interval, maximum QRS interval >=140 msec and a maximum IFB: Pctchg>=50%, maximum QTCF interval (Fridericia's Correction) of 450 msec to <480 msec, 480 msec to <500 msec or >=500 msec and a maximum change of <=30change<60 or >=60 msec from baseline. | Baseline up to Day 11 (11 days) |
| Shanghai |
| Shanghai Municipality |
| 200040 |
| China |
| Huashan Hospital Fudan University | Shanghai | Shanghai Municipality | 201107 | China |
| NOT COMPLETED |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
| Primary | Maximum Observed Plasma Concentration (Cmax) of Sisunatovir on Day 4 | Cmax was defined as maximum observed plasma concentration. | Analysis population included all participants who take at least 1 dose of study intervention and in whom at least 1 plasma concentration value is reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | 0, 1, 2, 3, 4, 5, 6, 8, 10, 12 hours post dose on Day 4 |
|
|
|
| Primary | Maximum Observed Plasma Concentration (Cmax) of Sisunatovir on Day 8 | Cmax was defined as maximum observed plasma concentration. | Analysis population included all participants who take at least 1 dose of study intervention and in whom at least 1 plasma concentration value is reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72 hours post dose on Day 8 |
|
|
|
| Primary | Area Under the Plasma Concentration-time Profile From Time Zero to Time 12 Hours (AUC12) of Sisunatovir on Day 1 | AUC12 was defined as area under the concentration-time curve from time zero to 12 hours. | Analysis population included all participants who take at least 1 dose of study intervention and have at least 1 of the PK parameters of interest calculated. One participant had emesis on Day 1 and therefore was excluded from the summaries. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | 0, 1, 2, 3, 4, 5, 6, 8, 10, 12 hours post dose on Day1 |
|
|
|
| Primary | Area Under the Plasma Concentration-time Profile From Time Zero to Time 12 Hours (AUC12) of Sisunatovir on Day 4 | AUC12 was defined as area under the concentration-time curve from time zero to 12 hours. | Analysis population included all participants who take at least 1 dose of study intervention and have at least 1 of the PK parameters of interest calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | 0, 1, 2, 3, 4, 5, 6, 8, 10, 12 hours post dose on Day 4 |
|
|
|
| Primary | Area Under the Plasma Concentration-time Profile From Time Zero to Time 12 Hours (AUC12) of Sisunatovir on Day 8 | AUC12 was defined as area under the concentration-time curve from time zero to 12 hours. | Analysis population included all participants who take at least 1 dose of study intervention and have at least 1 of the PK parameters of interest calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | 0, 1, 2, 3, 4, 5, 6, 8, 10, 12 hours post dose on Day 8 |
|
|
|
| Primary | Area Under the Plasma Concentration-time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of Sisunatovir on Day1 | AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. | Analysis population included all participants who take at least 1 dose of study intervention and have at least 1 of the PK parameters of interest calculated. One participant had emesis on Day 1 and therefore was excluded from the summaries. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72 hours post dose on Day1 |
|
|
|
| Primary | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) on Day1 | AUCinf was defined as area under the concentration-time curve from time 0 to infinity. | Analysis population included all participants who take at least 1 dose of study intervention and have at least 1 of the PK parameters of interest calculated. One participant had emesis on Day 1 and therefore was excluded from the summaries. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72 hours post dose on Day1 |
|
|
|
| Secondary | Time to Reach Cmax (Tmax) on Day 1, Day 4 and Day 8 | Tmax was defined as time to reach Cmax. | Analysis population included all participants who take at least 1 dose of study intervention and have at least 1 of the PK parameters of interest calculated. One participant had emesis on Day 1 and therefore was excluded from the summaries of Day 1. | Posted | Median | Full Range | hr (hour) | 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72 hours post dose on Day1, and Day 8. 0, 1, 2, 3, 4, 5, 6, 8, 10, 12 hours post dose on Day 4. |
|
|
|
| Secondary | Terminal Elimination Half-life (t½) on Day 1 and Day 8 | t½ was defined as terminal elimination half-life. | Analysis population included all participants who take at least 1 dose of study intervention and have at least 1 of the PK parameters of interest calculated. One participant had emesis on Day 1 and therefore was excluded from the summaries of Day 1. | Posted | Mean | Standard Deviation | hr (hour) | 0, 1, 2, 3, 4, 5, 6, 8, 10, 12,14, 24, 48, 72 hours post dose on Day1, and Day 8 |
|
|
|
| Secondary | Accumulation Ratio for Sisunatovir (Rac) | Rac is defined as: Observed accumulation ratio for AUCtau. Accumulation ratio on AUCtau = AUC12 (Day 8) /AUC12 (Day 4) | Analysis population included all participants who take at least 1 dose of study intervention and have at least 1 of the PK parameters of interest calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | 0, 1, 2, 3, 4, 5, 6, 8, 10, 12 hours post dose on Day 4 and Day 8 |
|
|
|
| Secondary | Accumulation Ratio on Cmax for Sisunatovir (Rac, Cmax) | Accumulation ratio on Cmax =Cmax (Day 8) /Cmax (Day 4) | Analysis population included all participants who take at least 1 dose of study intervention and have at least 1 of the PK parameters of interest calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | 0, 1, 2, 3, 4, 5, 6, 8, 10, 12 hours post dose on Day 4 and 0, 1, 2, 3, 4, 5, 6, 8, 10, 12,14, 24, 48, 72 hours post dose on Day 8 |
|
|
|
| Secondary | Number of Participants With All-Causality and Treatment-Related Treatment-emergent Adverse Events (TEAEs) | An AE is any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship with the study intervention. SAE is defined as one of the following: is fatal or life threatening; results in persistent or significant disability/incapacity; constitutes a congenital anomaly/birth defect; is medically significant; requires inpatient hospitalization or prolongation of existing hospitalization. Treatment-emergent AE is defined as an AE with onset date occurring during the on-treatment period. AEs include all SAEs and non-SAEs. | The analysis population included all participants who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From the first dose (Day 1) up to 35 days after the last dose (Day 8) of study intervention (up to 43 days) |
|
|
|
| Secondary | Number of Participants With Vital Signs Meeting the Pre-specified Criteria | Blood pressure (BP) and pulse rate were obtained with participant following at least a 5-minute rest in a supine position. Clinical significance of vital signs was determined at the investigator's discretion. | The analysis population included all participants who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Baseline up to Day 11 (11 days) |
|
|
|
| Secondary | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, platelet, neutrophils, eosinophils, monocytes, basophils, lymphocytes, leukocytes); clinical chemistry (alanine aminotransferase, albumin, alkaline phosphatase, bilirubin, calcium, carbon dioxide combining power, chloride, creatinine, cystatin C, GFR CKD-EPI serum creatinine 2021, gamma glutamyl transferase, glucose, potassium, sodium, urate, urea). urinalysis (Bilirubin, Glucose, Hemoglobin, Ketones, Leukocyte Esterase, Nitrite, Protein, Urobilinogen, pH).0 indicates no participants with abnormalities of all above lab examination. | The analysis population included all participants who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Baseline up to Day 11 (11 days) |
|
|
|
| Secondary | Number of Participants With Electrocardiogram (ECG) Abnormalities | Criteria for ECG abnormalities: maximum PR interval >=300 milliseconds (msec) and maximum increase PR interval increase from baseline (IFB): percent change (Pctchg) >=25 percent (%) for baseline value of >200 msec and Pctchg>=50% for baseline value of <=200 msec for PR interval, maximum QRS interval >=140 msec and a maximum IFB: Pctchg>=50%, maximum QTCF interval (Fridericia's Correction) of 450 msec to <480 msec, 480 msec to <500 msec or >=500 msec and a maximum change of <=30change<60 or >=60 msec from baseline. | The analysis population included all participants who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Baseline up to Day 11 (11 days) |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 7 |
| 12 |
| Diarrhoea | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
|
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 |
| D007239 | Infections |
|
| Day 8 |
|
|
|
| Title | Measurements |
|---|---|
|
| Participants with treatment related SAEs |
|
| Title | Measurements |
|---|---|
|
| supine diastolic BP value< 50mmHg |
|
| supine diastolic BP increase≥ 20mmHg |
|
| supine diastolic BP decrease≥ 20mmHg |
|
| pulse rate value<40 bpm |
|
| pulse rate value>120 bpm |
|