Respiratory Syncytial VirusesPhase 1NCT05712460

A Study to Assess the Safety, Effects and Palatability of Sisunatovir in Healthy Adult Participants

A Phase 1 study testing sisunatovir in people with Respiratory Syncytial Viruses, run by Pfizer at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study is seeking healthy participants who are: 1. Aged 18 to 65 years of age. All fertile participants must agree to use a highly effective method of contraception. 2. Male and female participants who are overtly healthy as determined by medical evaluation. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Respiratory Syncytial Viruses
What is being tested?: sisunatovir
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 12 participants
Where: 1 siteBelgium
Study dates: 8 Feb 2023to 28 Apr 2023
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Participants aged 18 to 65 years of age, inclusive, at the time of signing of the informed consent document (ICD).
All fertile participants must agree to use a highly effective method of contraception.
Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, including blood pressure, pulse rate, standard 12-lead electrocardiogram (ECG), and laboratory tests.
Body mass index (BMI) of 17.5 to 35 kg/m2; and a total body weight >50 kg (110 lb).

Who cannot join

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality, or other conditions or situations related to Coronavirus Disease 2019 (COVID-19) pandemic that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention with the exception of moderate/strong CYP3A inducers or time dependent inhibitors which are prohibited within 14 days plus 5 half lives prior to the first dose of study intervention.
A positive urine drug test, confirmed by a repeat test, if deemed necessary.
Screening supine blood pressure (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.
Standard 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.

Show all 12Show fewer

Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:
glomerular filtration rate (GFR) <60 mL/min/1.73m2 based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation;
Aspartate Aminotransferase (AST) or Alanine Transaminase (ALT) level ≥1.5 x upper limit of normal (ULN);
Gamma-glutamyl transferase (Gamma-GT)> ULN;
Alkaline phosphatase > 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.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, B-1070

Other trials in Belgium

About this study

Official title: A PHASE 1, RANDOMIZED, SPONSOR OPEN, TWO-PART CROSSOVER STUDY TO ASSESS SAFETY, TOLERABILITY, PHARMACOKINETICS AND FOOD EFFECT OF MULTIPLE DOSES IN PART 1 AND PALATABILITY OF A SINGLE DOSE OF SISUNATOVIR IN PART 2, IN HEALTHY ADULT PARTICIPANTS

This study is seeking healthy participants who are:

Aged 18 to 65 years of age. All fertile participants must agree to use a highly effective method of contraception.
Male and female participants who are overtly healthy as determined by medical evaluation. This includes medical history, physical examination, blood pressure, pulse rate, standard 12-lead ECG (electrocardiogram), and laboratory tests.
BMI (body mass index) of 17.5 to 35 kg/m2; and a total body weight >50 kg (110 lb).

This study will consist of up to 2 cohorts (groups of participants).:

Cohort 1 is a randomized, 2-part, crossover cohort. Part 1 has 3 periods. Periods 1 and 2 are to evaluate the safety and effects of sisunatovir. Participants will take sisunatovir tablets or placebo by mouth once every 12 hours. A placebo looks like the study medicine but does not contain any active medicine in it.

Period 3 is an open label period to evaluate the food effect of the planned higher dose of sisunatovir. Participants will take the planned higher dose sisunatovir tablets every 12 hours. In Part 2, participants will take sisunatovir prepared in 4 different vehicles (water, infant formula, apple juice, and saline) to assess how palatable each form is. Participants will complete a questionnaire after tasting each form of sisunatovir. The palatability questionnaire will be completed for each vehicle, the questionnaire asks participants to assess each vehicle at 4 different time increments after tasting. At least 60 minutes will pass between tasting each vehicle. Period 4 may start after the last PK draw of Period 3.

A minimum 7-day washout period will occur between the last dose of Periods 1 and 2 and the first dose of Periods 2 and 3. We will assess the safety of participants following each study period and doses and adjust the doses for subsequent study periods as needed.

Cohort 2 is an optional cohort; the design of Cohort 2 is the same as Part 1 of Cohort 1. Dose levels studied in Cohort 2 will be determined after the completion of Cohort 1.

Participants will take part in this study for approximately 2 months, excluding the screening period. During this time there are 3 separate 7-day in-patient stays at the study clinic and a follow-up phone call that takes place 28-35 days after the last dose of study medicine.

Conditions: Respiratory Syncytial Viruses
Being tested: sisunatovir, Placebo
Keywords: RSV, respiratory syncytial virus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

sisunatovirDrug
Sisunatovir is an orally administered RSV F-protein inhibitor being developed to target viral-host cell fusion for the treatment of adult and pediatric patients with RSV
PlaceboDrug
Placebo for sisunatovir

Study groups in NCT05712460
Study group	Role	What they receive
Group A: Higher dose sisunatovir	Experimental	higher dose of sisunatovir dosed every 12 hours Receives: Drug: sisunatovir
Group B: Lower dose sisunatovir	Experimental	Lower dose of sisunatovir dosed every 12 hours Receives: Drug: sisunatovir
Group C: Placebo	Placebo comparator	Placebo for sisunatovir dosed every 12 hours Receives: Drug: Placebo
Group D: Higher dose of sisunatovir	Experimental	Higher dose of sisunatovir dosed every 12 hours under fasted conditions Receives: Drug: sisunatovir
Group E: sisunatovir palatability	Experimental	Sisunatovir in 4 vehicles (water, saline, apple juice, infant formula) to assess the palatability of sisunatovir in each vehicle. sisunatovir will not be swallowed, participants will swirl and spit to assess various aspects of the taste. Receives: Drug: sisunatovir

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were any AEs that occurred following start of treatment.
Measured: From start of treatment to 28-35 days after last dose (maximum upto 66 days)
Number of Participants With Clinical Laboratory Abnormalities: Part 1
Laboratory tests included haematology (Monocytes [10^9/L] increase: > 1.2* upper limit of normal [ULN] and Monocytes/Leukocytes [percentage] {%}:> 1.2* ULN); clinical chemistry (serum) included Alanine Aminotransferase (units per liter [U/L]):> 3.0* ULN and Bicarbonate (milliequivalents per liter) (mEq/L): >1.1* ULN and in urinalysis (urine Hemoglobin (Scalar) more than equal to (>=) 1, urine Bilirubin (Scalar) >= 1, Hyaline Casts (/Low power field [LPF]) >= 1. Number of participants with any clinical laboratory abnormalities is reported in this outcome.
Measured: Up to Day 5
Number of Participants With Newly Occurring Notable Abnormal Vital Signs: Part 1
Supine blood pressure (BP) was measured with the participant's arm supported at the level of the heart and recorded after approximately 5 minutes of rest. Pulse rate was measured in the brachial/radial artery. Notable abnormal vital sign categories included: Systolic BP: <90 millimeter of mercury [mmHg]; Systolic BP change from baseline: maximum increase and decrease >=30 mmHg; Diastolic BP <50 mmHg; Diastolic BP change from baseline: maximum decrease and increase ≥20 mmHg; pulse rate <40 and >120 beats per minute. Number of participants with newly occurring notable abnormal vital sign (i.e. change in supine systolic BP >=30 millimeter of mercury [mmHg] increase) is reported in this outcome measure.
Measured: Up to Day 5
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings: Part 1
Standard 12-lead ECGs utilizing limb leads were used to measure PR interval, QT interval, QTc corrected using Fridericia's formula (QTcF), and QRS complex. ECG was performed after the participant had rested quietly for at least 5 minutes in a supine position. Clinical significance was determined by the investigator.
Measured: Up to Day 7

Secondary outcomes (24)

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Day 1: Part 1
Area under the concentration-time profile from time zero to time tau (the dosing interval), where tau = 12 hours for twice a day (BID) dosing.
Measured: Pre-dose, 1, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day 1
Dose Normalized AUCtau (AUCtau [dn]) for Day 1: Part 1
AUCtau(dn) was calculated as AUCtau/Dose.
Measured: Pre-dose, 1, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day 1
Maximum Observed Plasma Concentration (Cmax) for Day 1: Part 1
Measured: Pre-dose, 1, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day 1
Dose Normalized Maximum Plasma Concentration (Cmax [dn]) for Day 1: Part 1
Cmax(dn) was calculated as Cmax/Dose.
Measured: Pre-dose, 1, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day 1
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Day 1: Part 1
Measured: Pre-dose, 1, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day 1
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Day 5: Part 1
Area under the concentration-time profile from time zero to time tau (the dosing interval), where tau = 12 hours for BID dosing.
Measured: Pre-dose, 1, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day 5
AUCtau(dn) for Day 5: Part 1
AUCtau(dn) was calculated as AUCtau/Dose.
Measured: Pre-dose, 1, 2, 3,4, 5, 6, 8 and 12 hours post-dose on Day 5
Maximum Observed Plasma Concentration (Cmax) for Day 5: Part 1
Measured: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 5
Cmax(dn) for Day 5: Part 1
Cmax(dn) was calculated as Cmax/Dose.
Measured: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 5
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Day 5: Part 1
Measured: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 5
Apparent Clearance (CL/F) for Day 5: Part 1
CL/F was calculated as Dose/AUCtau.
Measured: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 5
Observed Accumulation Ratio (Rac) for AUC for Day 5: Part 1
Rac for AUC was calculated as AUCtau Day5/AUCtau Day1.
Measured: Pre-dose, 1, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day 1 and Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12 hours post-dose on Day 5
Observed Accumulation Ratio for Maximum Observed Plasma Concentration (Rac,Cmax) for Day 5: Part 1
Rac,Cmax was calculated as Cmax Day5/Cmax Day1.
Measured: Pre-dose, 1, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day 1 and Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 5
Plasma Decay Half-Life (t1/2) for Day 5: Part 1
Measured: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 5
Apparent Volume of Distribution (Vz/F) for Day 5: Part 1
Vz/F was calculated as Dose/(AUCtau * kel [Terminal phase rate constant]).
Measured: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 5
AUCtau for Day 5: Evaluation of Food Effect (Sisunatovir 200 mg Fed Versus Fasted): Part 1
Measured: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12 hours post-dose on Day 5
Cmax for Day 5: Evaluation of Food Effect (Sisunatovir 200 mg Fed Versus Fasted): Part 1
Measured: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 5
Assessment of Overall Liking Based on Palatability Assessment Questionnaire: Part 2
Participants were required to answer the palatability attribute of overall liking by providing a mark on the colour bar. The data was rescaled to a score ranging from 0 (good) to 100 (bad), where higher scores indicated less overall liking.
Measured: 1 minute (immediately following dose), 5,10 and 20 minutes after tasting dose in each vehicle
Assessment of Mouth Feel Based on Palatability Assessment Questionnaire: Part 2
Participants were required to answer the palatability attribute of mouth feel by providing a mark on the colour bar. The data was rescaled to a score ranging from 0 (good) to 100 (bad), where higher scores indicated worse mouth feel.
Measured: 1 minute (immediately following dose), 5,10 and 20 minutes after tasting dose in each vehicle
Assessment of Bitterness Based on Palatability Assessment Questionnaire: Part 2
Participants were required to answer the palatability attribute of bitterness by providing a mark on the colour bar. The data was rescaled to a score ranging from 0 (good) to 100 (bad), where higher scores indicated more bitterness.
Measured: 1 minute (immediately following dose), 5,10 and 20 minutes after tasting dose in each vehicle
Assessment of Tongue/Mouth Burn Based on Palatability Assessment Questionnaire: Part 2
Participants were required to answer the palatability attribute of tongue/mouth burn by providing a mark on the colour bar. The data was rescaled to a score ranging from 0 (good) to 100 (bad), where higher scores indicated more tongue/mouth burn.
Measured: 1 minute (immediately following dose), 5,10 and 20 minutes after tasting dose in each vehicle
Assessment of Sourness Based on Palatability Assessment Questionnaire: Part 2
Participants were required to answer the palatability attribute of sourness by providing a mark on the colour bar. The data was rescaled to a score ranging from 0 (good) to 100 (bad), where higher scores indicated increase in sourness.
Measured: 1 minute (immediately following dose), 5,10 and 20 minutes after tasting dose in each vehicle
Assessment of Saltiness Based on Palatability Assessment Questionnaire: Part 2
Participants were required to answer the palatability attribute of saltiness by providing a mark on the colour bar. The data was rescaled to a score ranging from 0 (good) to 100 (bad), where higher scores indicated more saltiness.
Measured: 1 minute (immediately following dose), 5,10 and 20 minutes after tasting dose in each vehicle
Assessment of Sweetness on Palatability Assessment Questionnaire: Part 2
Participants were required to answer the palatability attribute of sweetness by providing a mark on the colour bar. The data was rescaled to a score ranging from 0 (good) to 100 (bad), Participants were required to answer the palatability attribute of sweetness by providing a mark on the colour bar. The data was rescaled to a score ranging from 0 (good) to 100 (bad), where higher scores indicated more sweetness.
Measured: 1 minute (immediately following dose), 5,10 and 20 minutes after tasting dose in each vehicle

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Feb 202328 Apr 2023

First posted3 Feb 2023
Study start8 Feb 2023
Primary completion28 Apr 2023
Study completion28 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Respiratory Syncytial VirusesStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05712460
Sponsor's protocol ID: C5241006
Other IDs: 2022-003426-53
Status last verified: Apr 2024
First submitted: 25 Jan 2023
Last updated: 19 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Respiratory Syncytial Viruses trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1, RANDOMIZED, SPONSOR OPEN, TWO-PART CROSSOVER STUDY TO ASSESS SAFETY, TOLERABILITY, PHARMACOKINETICS AND FOOD EFFECT OF MULTIPLE DOSES IN PART 1 AND PALATABILITY OF A SINGLE DOSE OF SISUNATOVIR IN PART 2, IN HEALTHY ADULT PARTICIPANTS
ClinicalTrials.gov ID: NCT05712460
Acronym / sponsor ID: C5241006
Conditions: Respiratory Syncytial Viruses
Keywords: RSV, respiratory syncytial virus
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 8 Feb 2023 (actual)
Primary completion: 28 Apr 2023 (actual)
Study completion: 28 Apr 2023 (actual)
First posted: 3 Feb 2023 (actual)
Results: Posted 19 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is seeking healthy participants who are:

Aged 18 to 65 years of age. All fertile participants must agree to use a highly effective method of contraception.
Male and female participants who are overtly healthy as determined by medical evaluation. This includes medical history, physical examination, blood pressure, pulse rate, standard 12-lead ECG (electrocardiogram), and laboratory tests.
BMI (body mass index) of 17.5 to 35 kg/m2; and a total body weight >50 kg (110 lb).

This study will consist of up to 2 cohorts (groups of participants).:

Cohort 2 is an optional cohort; the design of Cohort 2 is the same as Part 1 of Cohort 1. Dose levels studied in Cohort 2 will be determined after the completion of Cohort 1.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Group A: Higher dose sisunatovir	Experimental	Drug: sisunatovirhigher dose of sisunatovir dosed every 12 hours
Group B: Lower dose sisunatovir	Experimental	Drug: sisunatovirLower dose of sisunatovir dosed every 12 hours
Group C: Placebo	Placebo comparator	Drug: PlaceboPlacebo for sisunatovir dosed every 12 hours
Group D: Higher dose of sisunatovir	Experimental	Drug: sisunatovirHigher dose of sisunatovir dosed every 12 hours under fasted conditions
Group E: sisunatovir palatability	Experimental	Drug: sisunatovirSisunatovir in 4 vehicles (water, saline, apple juice, infant formula) to assess the palatability of sisunatovir in each vehicle. sisunatovir will not be swallowed, participants will swirl and spit to assess various aspects of the taste.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Participants aged 18 to 65 years of age, inclusive, at the time of signing of the informed consent document (ICD).
Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, including blood pressure, pulse rate, standard 12-lead electrocardiogram (ECG), and laboratory tests.
Body mass index (BMI) of 17.5 to 35 kg/m2; and a total body weight >50 kg (110 lb).

Key exclusion criteria (12 listed)

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality, or other conditions or situations related to Coronavirus Disease 2019 (COVID-19) pandemic that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention with the exception of moderate/strong CYP3A inducers or time dependent inhibitors which are prohibited within 14 days plus 5 half lives prior to the first dose of study intervention.
A positive urine drug test, confirmed by a repeat test, if deemed necessary.
Screening supine blood pressure (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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
sisunatovirSisunatovir is an orally administered RSV F-protein inhibitor being developed to target viral-host cell fusion for the treatment of adult and pediatric patients with RSV	Drug	Group A: Higher dose sisunatovir, Group B: Lower dose sisunatovir, Group D: Higher dose of sisunatovir, Group E: sisunatovir palatability
PlaceboPlacebo for sisunatovir	Drug	Group C: Placebo

Primary outcome

Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: From start of treatment to 28-35 days after last dose (maximum upto 66 days)
An adverse event (AE) is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were any AEs that occurred following start of treatment.
Number of Participants With Clinical Laboratory Abnormalities: Part 1
Time frame: Up to Day 5
Laboratory tests included haematology (Monocytes [10^9/L] increase: > 1.2* upper limit of normal [ULN] and Monocytes/Leukocytes [percentage] {%}:> 1.2* ULN); clinical chemistry (serum) included Alanine Aminotransferase (units per liter [U/L]):> 3.0* ULN and Bicarbonate (milliequivalents per liter) (mEq/L): >1.1* ULN and in urinalysis (urine Hemoglobin (Scalar) more than equal to (>=) 1, urine Bilirubin (Scalar) >= 1, Hyaline Casts (/Low power field [LPF]) >= 1. Number of participants with any clinical laboratory abnormalities is reported in this outcome.
Number of Participants With Newly Occurring Notable Abnormal Vital Signs: Part 1
Time frame: Up to Day 5
Supine blood pressure (BP) was measured with the participant's arm supported at the level of the heart and recorded after approximately 5 minutes of rest. Pulse rate was measured in the brachial/radial artery. Notable abnormal vital sign categories included: Systolic BP: <90 millimeter of mercury [mmHg]; Systolic BP change from baseline: maximum increase and decrease >=30 mmHg; Diastolic BP <50 mmHg; Diastolic BP change from baseline: maximum decrease and increase ≥20 mmHg; pulse rate <40 and >120 beats per minute. Number of participants with newly occurring notable abnormal vital sign (i.e. change in supine systolic BP >=30 millimeter of mercury [mmHg] increase) is reported in this outcome measure.
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings: Part 1
Time frame: Up to Day 7
Standard 12-lead ECGs utilizing limb leads were used to measure PR interval, QT interval, QTc corrected using Fridericia's formula (QTcF), and QRS complex. ECG was performed after the participant had rested quietly for at least 5 minutes in a supine position. Clinical significance was determined by the investigator.

24 secondary outcomes

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Day 1: Part 1
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day 1
Dose Normalized AUCtau (AUCtau [dn]) for Day 1: Part 1
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day 1
Maximum Observed Plasma Concentration (Cmax) for Day 1: Part 1
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day 1
Dose Normalized Maximum Plasma Concentration (Cmax [dn]) for Day 1: Part 1
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day 1
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Day 1: Part 1
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day 1
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Day 5: Part 1
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day 5
AUCtau(dn) for Day 5: Part 1
Time frame: Pre-dose, 1, 2, 3,4, 5, 6, 8 and 12 hours post-dose on Day 5
Maximum Observed Plasma Concentration (Cmax) for Day 5: Part 1
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 5
Cmax(dn) for Day 5: Part 1
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 5
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Day 5: Part 1
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 5
Apparent Clearance (CL/F) for Day 5: Part 1
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 5
Observed Accumulation Ratio (Rac) for AUC for Day 5: Part 1
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day 1 and Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12 hours post-dose on Day 5
Observed Accumulation Ratio for Maximum Observed Plasma Concentration (Rac,Cmax) for Day 5: Part 1
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day 1 and Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 5
Plasma Decay Half-Life (t1/2) for Day 5: Part 1
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 5
Apparent Volume of Distribution (Vz/F) for Day 5: Part 1
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 5
AUCtau for Day 5: Evaluation of Food Effect (Sisunatovir 200 mg Fed Versus Fasted): Part 1
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12 hours post-dose on Day 5
Cmax for Day 5: Evaluation of Food Effect (Sisunatovir 200 mg Fed Versus Fasted): Part 1
Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 5
Assessment of Overall Liking Based on Palatability Assessment Questionnaire: Part 2
Time frame: 1 minute (immediately following dose), 5,10 and 20 minutes after tasting dose in each vehicle
Assessment of Mouth Feel Based on Palatability Assessment Questionnaire: Part 2
Time frame: 1 minute (immediately following dose), 5,10 and 20 minutes after tasting dose in each vehicle
Assessment of Bitterness Based on Palatability Assessment Questionnaire: Part 2
Time frame: 1 minute (immediately following dose), 5,10 and 20 minutes after tasting dose in each vehicle
Assessment of Tongue/Mouth Burn Based on Palatability Assessment Questionnaire: Part 2
Time frame: 1 minute (immediately following dose), 5,10 and 20 minutes after tasting dose in each vehicle
Assessment of Sourness Based on Palatability Assessment Questionnaire: Part 2
Time frame: 1 minute (immediately following dose), 5,10 and 20 minutes after tasting dose in each vehicle
Assessment of Saltiness Based on Palatability Assessment Questionnaire: Part 2
Time frame: 1 minute (immediately following dose), 5,10 and 20 minutes after tasting dose in each vehicle
Assessment of Sweetness on Palatability Assessment Questionnaire: Part 2
Time frame: 1 minute (immediately following dose), 5,10 and 20 minutes after tasting dose in each vehicle

Results and safety

Results posted to the registry on 19 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Sequence: ABDEFGH	1	1
Treatment Sequence: ABDFGHE	1	1
Treatment Sequence: ABDGHEF	1	1
Treatment Sequence: ACDEFGH	1	1
Treatment Sequence: ACDFGHE	1	1
Treatment Sequence: ACDGHEF	1	1
Treatment Sequence: BLDEFGH	1	1
Treatment Sequence: BLDFGHE	1	1
Treatment Sequence: BLDGHEF	1	1
Treatment Sequence: CLDEFGH	1	1
Treatment Sequence: CLDFGHE	1	1
Treatment Sequence: CLDGHEF	1	1

Primary outcome: Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Time frame: From start of treatment to 28-35 days after last dose (maximum upto 66 days). Count of participants. Unit: Participants

Measure	Part 1: Sisunatovir 400 mg, Fed n = 6	Part 1: Sisunatovir 200 mg, Fed n = 12	Part 1: Placebo, Fed n = 6	Part 1: Sisunatovir 200 mg, Fasted n = 11	Part 2: Sisunatovir 50 mg, Water n = 11	Part 2: Sisunatovir 50 mg, Formula n = 11	Part 2: Sisunatovir 50 mg, Apple Juice n = 11	Part 2: Sisunatovir 50 mg, Saline n = 11
Value	6	7	4	9	2	1	0	2

Population analysed: 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.

Primary outcome: Number of Participants With Clinical Laboratory Abnormalities: Part 1

Time frame: Up to Day 5. Count of participants. Unit: Participants

Measure	Sisunatovir 400 mg, Fed n = 6	Sisunatovir 200 mg, Fed n = 12	Placebo, Fed n = 6	Sisunatovir 200 mg, Fasted n = 11
Value	2	2	4	5

Primary outcome: Number of Participants With Newly Occurring Notable Abnormal Vital Signs: Part 1

Time frame: Up to Day 5. Count of participants. Unit: Participants

Measure	Sisunatovir 400 mg, Fed n = 6	Sisunatovir 200 mg, Fed n = 12	Placebo, Fed n = 6	Sisunatovir 200 mg, Fasted n = 11
Value	0	1	0	0

Primary outcome: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings: Part 1

Time frame: Up to Day 7. Count of participants. Unit: Participants

Measure	Sisunatovir 400 mg, Fed n = 6	Sisunatovir 200 mg, Fed n = 12	Placebo, Fed n = 6	Sisunatovir 200 mg, Fasted n = 11
Value	0	0	0	1

24 secondary outcomes are reported in the full results.

Adverse events

Time frame: From start of treatment to 28-35 days after last dose (maximum up to 66 days).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1: Sisunatovir 400 mg, Fed	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Part 1: Sisunatovir 200 mg, Fed	0 of 12 (0%)	7 of 12 (58.3%)	0 of 12
Part 1: Placebo, Fed	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Part 1: Sisunatovir 200 mg, Fasted	0 of 11 (0%)	9 of 11 (81.8%)	0 of 11
Part 2: Sisunatovir 50 mg, Water	0 of 11 (0%)	2 of 11 (18.2%)	0 of 11
Part 2: Sisunatovir 50 mg, Formula	0 of 11 (0%)	1 of 11 (9.1%)	0 of 11
Part 2: Sisunatovir 50 mg, Apple Juice	0 of 11 (0%)	0 of 11 (0%)	0 of 11
Part 2: Sisunatovir 50 mg, Saline	0 of 11 (0%)	2 of 11 (18.2%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing sisunatovir in people with Respiratory Syncytial Viruses, run by Pfizer at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment Emergent Adverse Events (TEAEs) (time frame: From start of treatment to 28-35 days after last dose (maximum upto 66 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05712460.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.