Trial Outcomes & Findings for A Study to Learn About the Study Medicine Sisunatovir in Adults With Respiratory Syncytial Virus (RSV) Infection (NCT NCT06079320)

NCT ID: NCT06079320

Last Updated: 2025-11-10

Results Overview

RSV related hospitalization included a specialized acute medical care unit within an assisted living facility or nursing home.

• Recruitment status: TERMINATED
• Study phase: PHASE2/PHASE3
• Target enrollment: 16 participants
• Primary outcome timeframe: From Day 1 (start of study intervention) up to Day 28
• Results posted on: 2025-11-10

Participant Flow

A total of 16 participants were enrolled at 16 centers in the United States, China, Japan and India.

Participant milestones

Measure	Sisunatovir Participants received oral doses of sisunatovir from Day 1 to Day 5.	Placebo Participants received oral doses of placebo from Day 1 to Day 5.
Treatment Phase STARTED	8	8
Treatment Phase COMPLETED	8	8
Treatment Phase NOT COMPLETED	0	0
Follow up Phase STARTED	8	8
Follow up Phase COMPLETED	7	8
Follow up Phase NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Sisunatovir Participants received oral doses of sisunatovir from Day 1 to Day 5.	Placebo Participants received oral doses of placebo from Day 1 to Day 5.
Follow up Phase Lost to Follow-up	1	0

Baseline Characteristics

A Study to Learn About the Study Medicine Sisunatovir in Adults With Respiratory Syncytial Virus (RSV) Infection

Baseline characteristics by cohort

Measure	Sisunatovir n=8 Participants Participants received oral doses of sisunatovir from Day 1 to Day 5.	Placebo n=8 Participants Participants received oral doses of placebo from Day 1 to Day 5.	Total n=16 Participants Total of all reporting groups
Age, Continuous	63.9 Years STANDARD_DEVIATION 10.96 • n=5 Participants	60.8 Years STANDARD_DEVIATION 9.13 • n=20 Participants	62.3 Years STANDARD_DEVIATION 9.88 • n=40 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=20 Participants	9 Participants n=40 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=20 Participants	7 Participants n=40 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=20 Participants	3 Participants n=40 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	5 Participants n=20 Participants	12 Participants n=40 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=20 Participants	1 Participants n=40 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=20 Participants	1 Participants n=40 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	3 Participants n=20 Participants	5 Participants n=40 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=20 Participants	3 Participants n=40 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	1 Participants n=20 Participants	5 Participants n=40 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=20 Participants	2 Participants n=40 Participants

PRIMARY outcome

Timeframe: From Day 1 (start of study intervention) up to Day 28

Population: Modified Intent-to-Treat-Infected (mITT-infected) population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention, and who had confirmed RSV infection.

RSV related hospitalization included a specialized acute medical care unit within an assisted living facility or nursing home.

Outcome measures

Measure	Sisunatovir n=4 Participants Participants received oral doses of sisunatovir from Day 1 to Day 5.	Placebo n=5 Participants Participants received oral doses of placebo from Day 1 to Day 5.
Number of Participants With Respiratory Syncytial Virus (RSV) Related Hospitalization or Death From Any Cause Through Day 28	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 1 (start of study intervention) up to Day 28

Population: mITT-infected population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention, and who had confirmed RSV infection.

Participants with RSV related visits in a hospital/urgent care or ED requiring no minimum duration of hospitalization were reported in this outcome measure. Investigators determined if a medical visit was related to RSV. RSV-related medical visits were those attendances that would not otherwise occur in the absence of the RSV infection. These may have included: deterioration or decompensation of the lung function that required supplemental oxygen; development of secondary respiratory tract infections that required antibiotic treatment; management of severe symptoms associated with RSV such as fever; worsening or decompensation of cardiac or renal function in participants with underlying cardiac or renal disease.

Outcome measures

Measure	Sisunatovir n=4 Participants Participants received oral doses of sisunatovir from Day 1 to Day 5.	Placebo n=5 Participants Participants received oral doses of placebo from Day 1 to Day 5.
Number of Participants With RSV-Related Visits (Urgent Care/ Emergency Department (ED)/Hospital) or Death From Any Cause Through Day 28	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From randomization on Day 1 up to Day 10

Population: mITT-infected population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention, and who had confirmed RSV infection. Here "Overall Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.

Progression of LRTI was defined as development of LRTI or transition from non-severe LRTI-RSV at randomization to severe LRTI-RSV at any time up to and including Day 10. LRTI was defined as: >= 2 lower respiratory signs or symptoms for at least 24 hours including at least 1 lower respiratory sign; or 3 lower respiratory symptoms for at least 24 hours. Lower respiratory symptoms included following: new or increased sputum, new or increased cough, new or increased dyspnea (shortness of breath). Lower respiratory signs included: new or increased wheezing, new or increased crackles/ronchi based on chest auscultation, respiratory rate >= 20 respirations/minute, low or decreased oxygen saturation (O2 less than (<) 95 percent (%) or <= 90% if pre-season baseline is < 95%), need for new or increased oxygen supplementation.

Outcome measures

Measure	Sisunatovir n=4 Participants Participants received oral doses of sisunatovir from Day 1 to Day 5.	Placebo n=3 Participants Participants received oral doses of placebo from Day 1 to Day 5.
Number of Participants With Progression of Lower Respiratory Tract Infection (LRTI) Through Day 10	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From randomization on Day 1 up to Day 10

Population: mITT-infected population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention, and who had confirmed RSV infection. Here "Overall Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.

Development of LRTI was defined as transitioning from not having LRTI at randomization but having nsLRTI-RSV or sLRTI-RSV at any time up to and including Day 10. LRTI was defined as: >= 2 lower respiratory signs or symptoms for at least 24 hours including at least 1 lower respiratory sign; or 3 lower respiratory symptoms for at least 24 hours. Lower respiratory symptoms included following: new or increased sputum, new or increased cough, new or increased dyspnea (shortness of breath). Lower respiratory signs included: new or increased wheezing, new or increased crackles/ronchi based on chest auscultation, respiratory rate >= 20 respirations/minute, low or decreased oxygen saturation (O2 < 95 % or <= 90% if pre-season baseline is < 95%), need for new or increased oxygen supplementation.

Outcome measures

Measure	Sisunatovir n=1 Participants Participants received oral doses of sisunatovir from Day 1 to Day 5.	Placebo n=2 Participants Participants received oral doses of placebo from Day 1 to Day 5.
Number of Participants With Development of LRTI Through Day 10	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 15

Population: mITT-infected population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention, and who had confirmed RSV infection. Here "Overall Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.

Resolution of LRTI was defined as transition from RSV-related non-severe LRTI (nsLRTI-RSV) or RSV-related severe LRTI (sLRTI-RSV) at randomization to not having nsLRTI and sLRTI-RSV. LRTI was defined as: >= 2 lower respiratory signs or symptoms for at least 24 hours including at least 1 lower respiratory sign; or 3 lower respiratory symptoms for at least 24 hours. Lower respiratory symptoms included following: new or increased sputum, new or increased cough, new or increased dyspnea (shortness of breath). Lower respiratory signs included: new or increased wheezing, new or increased crackles/ronchi based on chest auscultation, respiratory rate >= 20 respirations/minute, low or decreased oxygen saturation (O2 < 95 % or <= 90% if pre-season baseline is < 95%), need for new or increased oxygen supplementation.

Outcome measures

Measure	Sisunatovir n=3 Participants Participants received oral doses of sisunatovir from Day 1 to Day 5.	Placebo n=3 Participants Participants received oral doses of placebo from Day 1 to Day 5.
Number of Participants With Resolution of LRTI at Day 15	1 Participants	1 Participants

SECONDARY outcome

Timeframe: From Day 1 (start of study intervention) up to Day 28

Population: mITT-infected population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention, and who had confirmed RSV infection.

Outcome measures

Measure	Sisunatovir n=4 Participants Participants received oral doses of sisunatovir from Day 1 to Day 5.	Placebo n=5 Participants Participants received oral doses of placebo from Day 1 to Day 5.
Mean Number of Hospital Free Days Through Day 28	28.0 Days Standard Deviation 0.00	28.0 Days Standard Deviation 0.00

SECONDARY outcome

Timeframe: From randomization on Day 1 up to Days 3, 5, 15 and 28

Population: mITT-infected population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention, and who had confirmed RSV infection. Here "Overall Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.

Progression of LRTI was defined as development of LRTI or transition from non severe LRTI-RSV at randomization to severe LRTI-RSV at any time up to and including Days 3, 5, 15 and 28. LRTI was defined as: >= 2 lower respiratory signs or symptoms for at least 24 hours including at least 1 lower respiratory sign; or 3 lower respiratory symptoms for at least 24 hours. Lower respiratory symptoms included following: new or increased sputum, new or increased cough, new or increased dyspnea (shortness of breath). Lower respiratory signs included: new or increased wheezing, new or increased crackles/ronchi based on chest auscultation, respiratory rate >= 20 respirations/minute, low or decreased oxygen saturation (O2 < 95 % or <= 90% if pre-season baseline is < 95%), need for new or increased oxygen supplementation.

Outcome measures

Measure	Sisunatovir n=4 Participants Participants received oral doses of sisunatovir from Day 1 to Day 5.	Placebo n=3 Participants Participants received oral doses of placebo from Day 1 to Day 5.
Number of Participants With Progression of LRTI Through Days 3, 5, 15 and 28 Day 3	0 Participants	0 Participants
Number of Participants With Progression of LRTI Through Days 3, 5, 15 and 28 Day 5	0 Participants	0 Participants
Number of Participants With Progression of LRTI Through Days 3, 5, 15 and 28 Day 15	0 Participants	0 Participants
Number of Participants With Progression of LRTI Through Days 3, 5, 15 and 28 Day 28	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From randomization on Day 1 up to Days 3, 5, 15 and 28

Population: mITT-infected population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention, and who had confirmed RSV infection. Here "Overall Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.

Development of LRTI was defined as transitioning from not having LRTI at randomization but having nsLRTI-RSV or sLRTI-RSV at any time up to and including Days 3, 5, 15 and 28. LRTI was defined as: >= 2 lower respiratory signs or symptoms for at least 24 hours including at least 1 lower respiratory sign; or 3 lower respiratory symptoms for at least 24 hours. Lower respiratory symptoms included following: new or increased sputum, new or increased cough, new or increased dyspnea (shortness of breath). Lower respiratory signs included: new or increased wheezing, new or increased crackles/ronchi based on chest auscultation, respiratory rate >= 20 respirations/minute, low or decreased oxygen saturation (O2 < 95 % or <= 90% if pre-season baseline is < 95%), need for new or increased oxygen supplementation.

Outcome measures

Measure	Sisunatovir n=1 Participants Participants received oral doses of sisunatovir from Day 1 to Day 5.	Placebo n=2 Participants Participants received oral doses of placebo from Day 1 to Day 5.
Number of Participants With Development of LRTI Through Days 3, 5, 15 and 28 Day 3	0 Participants	0 Participants
Number of Participants With Development of LRTI Through Days 3, 5, 15 and 28 Day 5	0 Participants	0 Participants
Number of Participants With Development of LRTI Through Days 3, 5, 15 and 28 Day 15	0 Participants	0 Participants
Number of Participants With Development of LRTI Through Days 3, 5, 15 and 28 Day 28	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At Days 3, 5, 10 and 28

Population: mITT-infected population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention, and who had confirmed RSV infection. Here, "Overall Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.

Resolution of LRTI was defined as transition from nsLRTI-RSV or sLRTI-RSV at randomization to not having nsLRTI and sLRTI-RSV. LRTI was defined as >= 2 lower respiratory signs or symptoms for at least 24 hours including at least 1 lower respiratory sign; or 3 lower respiratory symptoms for at least 24 hours. Lower respiratory symptoms included following: new or increased sputum, new or increased cough, new or increased dyspnea (shortness of breath). Lower respiratory signs included: new or increased wheezing, new or increased crackles/ronchi based on chest auscultation, respiratory rate >= 20 respirations/minute, low or decreased oxygen saturation (O2 < 95% or <= 90% if pre-season baseline is < 95%), need for new or increased oxygen supplementation.

Outcome measures

Measure	Sisunatovir n=3 Participants Participants received oral doses of sisunatovir from Day 1 to Day 5.	Placebo n=3 Participants Participants received oral doses of placebo from Day 1 to Day 5.
Number of Participants With Resolution of LRTI at Days 3, 5, 10 and 28 Day 3	1 Participants	1 Participants
Number of Participants With Resolution of LRTI at Days 3, 5, 10 and 28 Day 5	1 Participants	1 Participants
Number of Participants With Resolution of LRTI at Days 3, 5, 10 and 28 Day 10	1 Participants	1 Participants
Number of Participants With Resolution of LRTI at Days 3, 5, 10 and 28 Day 28	2 Participants	3 Participants

SECONDARY outcome

Timeframe: At Days 3, 5, 10, 15 and 28

Population: mITT-infected population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention, and who had confirmed RSV infection. Here "Overall Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure.

Improvement in LRTI status was defined as LRTI resolution or transition from sLRTI-RSV at randomization to nsLRTI-RSV. LRTI was defined as: >= 2 lower respiratory signs or symptoms for at least 24 hours including at least 1 lower respiratory sign; or 3 lower respiratory symptoms for at least 24 hours. Lower respiratory symptoms included following: new or increased sputum, new or increased cough, new or increased dyspnea (shortness of breath). Lower respiratory signs included: new or increased wheezing, new or increased crackles/ronchi based on chest auscultation, respiratory rate >= 20 respirations/minute, low or decreased oxygen saturation (O2 < 95 % or <= 90% if pre-season baseline is < 95%), need for new or increased oxygen supplementation.

Outcome measures

Measure	Sisunatovir n=3 Participants Participants received oral doses of sisunatovir from Day 1 to Day 5.	Placebo n=3 Participants Participants received oral doses of placebo from Day 1 to Day 5.
Number of Participants With Improvement of LRTI at Days 3, 5, 10, 15 and 28 Day 3	1 Participants	2 Participants
Number of Participants With Improvement of LRTI at Days 3, 5, 10, 15 and 28 Day 5	1 Participants	2 Participants
Number of Participants With Improvement of LRTI at Days 3, 5, 10, 15 and 28 Day 10	1 Participants	2 Participants
Number of Participants With Improvement of LRTI at Days 3, 5, 10, 15 and 28 Day 15	1 Participants	3 Participants
Number of Participants With Improvement of LRTI at Days 3, 5, 10, 15 and 28 Day 28	2 Participants	3 Participants

SECONDARY outcome

Timeframe: From Day 1 (start of study intervention) up to Day 28

Population: mITT-infected population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention, and who had confirmed RSV infection.

RSV related hospitalization included a specialized acute medical care unit within an assisted living facility or nursing home.

Outcome measures

Measure	Sisunatovir n=4 Participants Participants received oral doses of sisunatovir from Day 1 to Day 5.	Placebo n=5 Participants Participants received oral doses of placebo from Day 1 to Day 5.
Mean Number of RSV Related Days in Hospital Through Day 28	0 Days Standard Deviation 0	0 Days Standard Deviation 0

SECONDARY outcome

Timeframe: From Day 1 (start of study intervention) up to Day 28

Population: mITT-infected population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention, and who had confirmed RSV infection.

Outcome measures

Measure	Sisunatovir n=4 Participants Participants received oral doses of sisunatovir from Day 1 to Day 5.	Placebo n=5 Participants Participants received oral doses of placebo from Day 1 to Day 5.
Mean Number of RSV Related Days in Intensive Care Unit (ICU) Through Day 28	0 Days Standard Deviation 0	0 Days Standard Deviation 0

SECONDARY outcome

Timeframe: At Days 5, 10, 15, and 28

Population: mITT-infected population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention, and who had confirmed RSV infection.

Improvement was defined as no new acute respiratory infection (ARI) signs or symptoms, and no worsening of existing signs or symptoms compared to the Day 1 visit. At least one sign or symptom (but not all) present at Day 1 was absent, improved or returned to pre-infection status. Resolution was defined as all ARI signs or symptoms were absent or returned to pre-infection status. Clinical response was evaluated by the investigator.

Outcome measures

Measure	Sisunatovir n=4 Participants Participants received oral doses of sisunatovir from Day 1 to Day 5.	Placebo n=5 Participants Participants received oral doses of placebo from Day 1 to Day 5.
Number of Participants With a Clinical Response of Improvement or Resolution at Days 5, 10, 15, and 28 Day 5	3 Participants	5 Participants
Number of Participants With a Clinical Response of Improvement or Resolution at Days 5, 10, 15, and 28 Day 10	4 Participants	5 Participants
Number of Participants With a Clinical Response of Improvement or Resolution at Days 5, 10, 15, and 28 Day 15	3 Participants	5 Participants
Number of Participants With a Clinical Response of Improvement or Resolution at Days 5, 10, 15, and 28 Day 28	3 Participants	5 Participants

SECONDARY outcome

Timeframe: At Days 3, 5, 10, 15, and 28

Population: mITT-infected population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention, and who had confirmed RSV infection.

Undetectable RSV viral load at a visit was defined as a central PCR laboratory result of target not detected (TND).

Outcome measures

Measure	Sisunatovir n=4 Participants Participants received oral doses of sisunatovir from Day 1 to Day 5.	Placebo n=5 Participants Participants received oral doses of placebo from Day 1 to Day 5.
Number of Participants With Undetectable RSV Viral Load at Days 3, 5, 10, 15 and 28 Day 5	0 Participants	1 Participants
Number of Participants With Undetectable RSV Viral Load at Days 3, 5, 10, 15 and 28 Day 10	1 Participants	2 Participants
Number of Participants With Undetectable RSV Viral Load at Days 3, 5, 10, 15 and 28 Day 15	4 Participants	5 Participants
Number of Participants With Undetectable RSV Viral Load at Days 3, 5, 10, 15 and 28 Day 28	4 Participants	5 Participants
Number of Participants With Undetectable RSV Viral Load at Days 3, 5, 10, 15 and 28 Day 3	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (within 1 hour post start of study intervention on Day 1) and Days 3, 5, 10, 15, and 28

Population: mITT-infected population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention, and who had confirmed RSV infection.

Undetectable viral load was considered to be 0 copies/mL for this analysis.

Outcome measures

Measure	Sisunatovir n=4 Participants Participants received oral doses of sisunatovir from Day 1 to Day 5.	Placebo n=5 Participants Participants received oral doses of placebo from Day 1 to Day 5.
Change From Baseline in Log10 Transformed Total RSV Viral Load at Days 3, 5, 10, 15 and 28 Day 3	-1.453 Log10 copies/mL Standard Deviation 1.2107	-1.184 Log10 copies/mL Standard Deviation 1.2960
Change From Baseline in Log10 Transformed Total RSV Viral Load at Days 3, 5, 10, 15 and 28 Day 5	-1.788 Log10 copies/mL Standard Deviation 2.0327	-1.626 Log10 copies/mL Standard Deviation 1.6493
Change From Baseline in Log10 Transformed Total RSV Viral Load at Days 3, 5, 10, 15 and 28 Day 10	-4.445 Log10 copies/mL Standard Deviation 1.5779	-2.784 Log10 copies/mL Standard Deviation 1.8207
Change From Baseline in Log10 Transformed Total RSV Viral Load at Days 3, 5, 10, 15 and 28 Day 15	-6.110 Log10 copies/mL Standard Deviation 2.6486	-4.900 Log10 copies/mL Standard Deviation 1.7815
Change From Baseline in Log10 Transformed Total RSV Viral Load at Days 3, 5, 10, 15 and 28 Day 28	-6.110 Log10 copies/mL Standard Deviation 2.6486	-4.900 Log10 copies/mL Standard Deviation 1.7815

SECONDARY outcome

Timeframe: From Day 1 of study intervention up to 28-30 days after last dose of study drug (up to Day 35)

Population: Safety analysis set (SAS) included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An adverse event was considered a TEAE if the event started on or after the study intervention start date (Day 1).

Outcome measures

Measure	Sisunatovir n=8 Participants Participants received oral doses of sisunatovir from Day 1 to Day 5.	Placebo n=8 Participants Participants received oral doses of placebo from Day 1 to Day 5.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Through Day 35	1 Participants	4 Participants

SECONDARY outcome

Timeframe: From Day 1 of study intervention up to 28-30 days after last dose of study drug (up to Day 35)

Population: SAS included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the criteria listed below: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, suspected transmission via a Pfizer product of an infectious agent, pathogenic or nonpathogenic and other important medical event.

Outcome measures

Measure	Sisunatovir n=8 Participants Participants received oral doses of sisunatovir from Day 1 to Day 5.	Placebo n=8 Participants Participants received oral doses of placebo from Day 1 to Day 5.
Number of Participants With Treatment Emergent Serious Adverse Events (TESAE) Through Day 35	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Anytime between 3 to 8 hours post dose on Day 3, and pre-dose on Day 5

Population: Pharmacokinetic (PK) concentration analysis set included all participants who received at least 1 dose of sisunatovir and in whom at least 1 concentration value was reported. Here, "Number Analyzed" signifies participants evaluable for the specified rows.

Outcome measures

Measure	Sisunatovir n=7 Participants Participants received oral doses of sisunatovir from Day 1 to Day 5.	Placebo Participants received oral doses of placebo from Day 1 to Day 5.
Plasma Concentrations of Sisunatovir at Days 3 and 5 Day 3	98.26 Nanogram per milliliter Standard Deviation 141.41	—
Plasma Concentrations of Sisunatovir at Days 3 and 5 Day 5	173.1 Nanogram per milliliter Standard Deviation 231.83	—

Adverse Events

Sisunatovir

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Sisunatovir n=8 participants at risk Participants received oral doses of sisunatovir from Day 1 to Day 5.	Placebo n=8 participants at risk Participants received oral doses of placebo from Day 1 to Day 5.
Investigations Gamma-glutamyltransferase increased	0.00% 0/8 • From Day 1 of study intervention up to 28-30 days after last dose of study drug (up to Day 35) SAS included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	12.5% 1/8 • From Day 1 of study intervention up to 28-30 days after last dose of study drug (up to Day 35) SAS included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Nervous system disorders Head discomfort	0.00% 0/8 • From Day 1 of study intervention up to 28-30 days after last dose of study drug (up to Day 35) SAS included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	12.5% 1/8 • From Day 1 of study intervention up to 28-30 days after last dose of study drug (up to Day 35) SAS included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Nervous system disorders Headache	12.5% 1/8 • From Day 1 of study intervention up to 28-30 days after last dose of study drug (up to Day 35) SAS included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	0.00% 0/8 • From Day 1 of study intervention up to 28-30 days after last dose of study drug (up to Day 35) SAS included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Gastrointestinal disorders Constipation	0.00% 0/8 • From Day 1 of study intervention up to 28-30 days after last dose of study drug (up to Day 35) SAS included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	12.5% 1/8 • From Day 1 of study intervention up to 28-30 days after last dose of study drug (up to Day 35) SAS included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Infections and infestations Upper respiratory tract infection	0.00% 0/8 • From Day 1 of study intervention up to 28-30 days after last dose of study drug (up to Day 35) SAS included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	12.5% 1/8 • From Day 1 of study intervention up to 28-30 days after last dose of study drug (up to Day 35) SAS included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Investigations Alanine aminotransferase increased	0.00% 0/8 • From Day 1 of study intervention up to 28-30 days after last dose of study drug (up to Day 35) SAS included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.	12.5% 1/8 • From Day 1 of study intervention up to 28-30 days after last dose of study drug (up to Day 35) SAS included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 18007181021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication 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.
• Publication restrictions are in place

Restriction type: OTHER