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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-003426-53 | EudraCT Number |
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This study is seeking healthy participants who are:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Higher dose sisunatovir | Experimental | higher dose of sisunatovir dosed every 12 hours |
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| Group B: Lower dose sisunatovir | Experimental | Lower dose of sisunatovir dosed every 12 hours |
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| Group C: Placebo | Placebo Comparator | Placebo for sisunatovir dosed every 12 hours |
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| Group D: Higher dose of sisunatovir | Experimental | Higher dose of sisunatovir dosed every 12 hours under fasted conditions |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sisunatovir | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Up to Day 5 |
| Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings: Part 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Inclusion Criteria:
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).
Exclusion Criteria:
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.
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:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit - Brussels | Brussels | Bruxelles-capitale, Région de | B-1070 | Belgium |
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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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A total of 12 participants were enrolled at 1 site in Brussels.
This study was planned to be conducted in 2 cohorts: Cohort 1 and optional Cohort 2. Cohort 1 had 2 parts, Part 1 had 3 periods (Period 1, 2, 3) and Part 2 had 4 periods (Period 4, 5, 6, 7). The optional cohort 2 was not conducted based on the findings for Cohort 1.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Sequence: ABDEFGH | Sisunatovir 400 mg, Fed (treatment A) was administered once every 12 hours (Q12h) for 4 days in Period 1, followed by sisunatovir 200 mg plus matching placebo, Fed (treatment B) Q12h for 4 days in Period 2 followed by sisunatovir 200 mg, Fasted (treatment D) administered Q12h for 4 days in Period 3. There was a washout period of minimum 7 days between each subsequent period. Participants tasted sisunatovir 50 mg capsule content in water (treatment E) followed by sisunatovir 50 mg in Formula (treatment F) sisunatovir 50 mg in apple juice (treatment G) and sisunatovir 50 mg in saline (treatment H) on Day 1 of treatment period 4 to 7. There was a washout of at least 60 minutes between tasting each vehicle. |
| FG001 | Treatment Sequence: ABDFGHE | Sisunatovir 400 mg, Fed (treatment A) was administered Q12h for 4 days in Period 1, followed by sisunatovir 200 mg plus matching placebo, Fed (treatment B) Q12h for 4 days in Period 2 followed by sisunatovir 200 mg, Fasted (treatment D) administered Q12h for 4 days in Period 3. There was a washout period of minimum 7 days between each subsequent period. Participants tasted sisunatovir 50 mg in Formula (treatment F) followed by sisunatovir 50 mg in apple juice (treatment G) and sisunatovir 50 mg in saline (treatment H), sisunatovir 50 mg capsule content in water (treatment E) on Day 1 of treatment period 4 to 7. There was a washout of at least 60 minutes between tasting each vehicle. |
| FG002 | Treatment Sequence: ABDGHEF | Sisunatovir 400 mg, Fed (treatment A) was administered Q12h for 4 days in Period 1, followed by sisunatovir 200 mg plus matching placebo, Fed (treatment B) Q12h for 4 days in Period 2 followed by sisunatovir 200 mg, Fasted (treatment D) administered Q12h for 4 days in Period 3. There was a washout period of minimum 7 days between each subsequent period. Participants tasted sisunatovir 50 mg in apple juice (treatment G) and sisunatovir 50 mg in saline (treatment H), sisunatovir 50 mg capsule content in water (treatment E), sisunatovir 50 mg in Formula (treatment F) on Day 1 of treatment period 4 to 7. There was a washout of at least 60 minutes between tasting each vehicle. |
| FG003 | Treatment Sequence: ACDEFGH | Sisunatovir 400 mg, Fed (treatment A) was administered Q12h for 4 days in Period 1, followed by Placebo, Fed (treatment C) Q12h for 4 days in Period 2 followed by sisunatovir 200 mg, Fasted (treatment D) administered Q12h for 4 days in Period 3. There was a washout period of minimum 7 days between each subsequent period. Participants tasted Sisunatovir 50 mg, Water (Treatment E) sisunatovir 50 mg in Formula (treatment F), sisunatovir 50 mg in apple juice (treatment G) and sisunatovir 50 mg in saline (treatment H), on Day 1 of treatment period 4 to 7. There was a washout of at least 60 minutes between tasting each vehicle. |
| FG004 | Treatment Sequence: ACDFGHE | Sisunatovir 400 mg, Fed (treatment A) was administered Q12h for 4 days in Period 1, followed by Placebo, Fed (treatment C) Q12h for 4 days in Period 2 followed by sisunatovir 200 mg, Fasted (treatment D) administered Q12h for 4 days in Period 3. There was a washout period of minimum 7 days between each subsequent period. Participants tasted sisunatovir 50 mg in Formula (treatment F), sisunatovir 50 mg in apple juice (treatment G), sisunatovir 50 mg in saline (treatment H), Sisunatovir 50 mg, Water (Treatment E), and on Day 1 of treatment period 4 to 7. There was a washout of at least 60 minutes between tasting each vehicle. |
| FG005 | Treatment Sequence: ACDGHEF | Sisunatovir 400 mg, Fed (treatment A) was administered Q12h for 4 days in Period 1, followed by Placebo, Fed (treatment C) Q12h for 4 days in Period 2 followed by sisunatovir 200 mg, Fasted (treatment D) administered Q12h for 4 days in Period 3. There was a washout period of minimum 7 days between each subsequent period. Participants tasted sisunatovir 50 mg in apple juice (treatment G), sisunatovir 50 mg in saline (treatment H), Sisunatovir 50 mg, Water (Treatment E), and sisunatovir 50 mg in Formula (treatment F) on Day 1 of treatment period 4 to 7. There was a washout of at least 60 minutes between tasting each vehicle. |
| FG006 | Treatment Sequence: BLDEFGH | Sisunatovir 200 mg, Fed (treatment B) was administered Q12h for 4 days in Period 1, followed by Sisunatovir 200 mg, Fed (treatment L) Q12h for 4 days in Period 2 followed by sisunatovir 200 mg, Fasted (treatment D) administered Q12h for 4 days in Period 3. There was a washout period of minimum 7 days between each subsequent period. Participants tasted sisunatovir 50 mg capsule content in water (treatment E), sisunatovir 50 mg in Formula (treatment F), sisunatovir 50 mg in apple juice (treatment G) and sisunatovir 50 mg in saline (treatment H), on Day 1 of treatment period 4 to 7. There was a washout of at least 60 minutes between tasting each vehicle. |
| FG007 | Treatment Sequence: BLDFGHE | Sisunatovir 200 mg, Fed (treatment B) was administered Q12h for 4 days in Period 1, followed by Sisunatovir 200 mg, Fed (treatment L) Q12h for 4 days in Period 2 followed by sisunatovir 200 mg, Fasted (treatment D) administered Q12h for 4 days in Period 3. There was a washout period of minimum 7 days between each subsequent period. Participants tasted sisunatovir 50 mg in Formula (treatment F), sisunatovir 50 mg in apple juice (treatment G) and sisunatovir 50 mg in saline (treatment H) and sisunatovir 50 mg capsule content in water (treatment E) on Day 1 of treatment period 4 to 7. There was a washout of at least 60 minutes between tasting each vehicle. |
| FG008 | Treatment Sequence: BLDGHEF | Sisunatovir 200 mg, Fed (treatment B) was administered Q12h for 4 days in Period 1, followed by Sisunatovir 200 mg, Fed (treatment L) Q12h for 4 days in Period 2 followed by sisunatovir 200 mg, Fasted (treatment D) administered Q12h for 4 days in Period 3. There was a washout period of minimum 7 days between each subsequent period. Participants tasted sisunatovir 50 mg in apple juice (treatment G), sisunatovir 50 mg in saline (treatment H), sisunatovir 50 mg capsule content in water (treatment E) and sisunatovir 50 mg in Formula (treatment F) on Day 1 of treatment period 4 to 7. There was a washout of at least 60 minutes between tasting each vehicle. |
| FG009 | Treatment Sequence: CLDEFGH | Placebo, Fed (treatment C) was administered Q12h for 4 days in Period 1, followed by Sisunatovir 200 mg, Fed (treatment L) Q12h for 4 days in Period 2 followed by sisunatovir 200 mg, Fasted (treatment D) administered Q12h for 4 days in Period 3. There was a washout period of minimum 7 days between each subsequent period. Participants tasted sisunatovir 50 mg capsule content in water (treatment E), sisunatovir 50 mg in Formula (treatment F) sisunatovir 50 mg in apple juice (treatment G) and sisunatovir 50 mg in saline (treatment H) on Day 1 of treatment period 4 to 7. There was a washout of at least 60 minutes between tasting each vehicle. |
| FG010 | Treatment Sequence: CLDFGHE | Placebo, Fed (treatment C) was administered Q12h for 4 days in Period 1, followed by Sisunatovir 200 mg, Fed (treatment L) Q12h for 4 days in Period 2 followed by sisunatovir 200 mg, Fasted (treatment D) administered Q12h for 4 days in Period 3. There was a washout period of minimum 7 days between each subsequent period. Participants tasted sisunatovir 50 mg in Formula (treatment F) sisunatovir 50 mg in apple juice (treatment G) and sisunatovir 50 mg in saline (treatment H) and sisunatovir 50 mg capsule content in water (treatment E) on Day 1 of treatment period 4 to 7. There was a washout of at least 60 minutes between tasting each vehicle. |
| FG011 | Treatment Sequence: CLDGHEF | Placebo, Fed (treatment C) was administered Q12h for 4 days in Period 1, followed by Sisunatovir 200 mg, Fed (treatment L) Q12h for 4 days in Period 2 followed by sisunatovir 200 mg, Fasted (treatment D) administered Q12h for 4 days in Period 3. There was a washout period of minimum 7 days between each subsequent period. Participants tasted sisunatovir 50 mg in apple juice (treatment G) and sisunatovir 50 mg in saline (treatment H) and sisunatovir 50 mg capsule content in water (treatment E) and sisunatovir 50 mg in Formula (treatment F) on Day 1 of treatment period 4 to 7. There was a washout of at least 60 minutes between tasting each vehicle. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1 Period 1 (4 Days) |
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| Part 1 Period 2 (4 Days) |
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| Part 1 Period 3 (4 Days) |
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| Part 2 Period 4 (1 Day) |
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| Part 2 Period 5 (1 Day) |
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| Part 2 Period 6 (1 Day) |
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| Part 2 Period 7 (1 Day) |
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Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants who were randomized to either of the treatment sequence and received Sisunatovir 400 mg, Fed (A) Sisunatovir 200 mg, Fed (B), Placebo, Fed (treatment C), Sisunatovir 200 mg, Fasted (D), Sisunatovir 200 mg, Fed (treatment L), Sisunatovir 50 mg, Water (E), Sisunatovir 50 mg, Formula (F), Sisunatovir 50 mg, Apple Juice (G), Sisunatovir 50 mg, Saline (H) in any of the treatment periods were included. Participants were administered either Sisunatovir 200 mg in the fed state, Sisunatovir 400 mg in the fed state or placebo in fed state in Period 1 and 2, Sisunatovir 200 mg in fasted state in Period 3 and tasted Sisunatovir 50 mg capsule in either water, formula, apple juice or saline in Periods 4 to 7. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Count of Participants | Participants | From start of treatment to 28-35 days after last dose (maximum upto 66 days) |
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From start of treatment to 28-35 days after last dose (maximum up to 66 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 | Part 1: Sisunatovir 400 mg, Fed | Participants were administered sisunatovir 400 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA v26.0 | 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 | Dec 23, 2022 | Apr 11, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 14, 2023 | Apr 11, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000717948 | sisunatovir |
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| Placebo | Drug | Placebo for sisunatovir |
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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.
| Up to Day 7 |
AUCtau(dn) was calculated as AUCtau/Dose. |
| 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 | 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. | 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 | 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. | 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. | 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 | 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. | 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 | 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. | 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. | 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. | 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 | 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]). | 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 | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 1 minute (immediately following dose), 5,10 and 20 minutes after tasting dose in each vehicle |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 | Part 1: Sisunatovir 200 mg, Fed | Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1. |
| OG002 | Part 1: Placebo, Fed | Participants were administered placebo once every 12 hours for 4 days plus 1 dose in a fed state in either period 1 or 2 of Part 1. |
| OG003 | Part 1: Sisunatovir 200 mg, Fasted | Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose in a fasted state in period 3 of Part 1. |
| OG004 | Part 2: Sisunatovir 50 mg, Water | Participants tasted sisunatovir 50 mg capsule content in water and then spat out the drug to assess the palatability. |
| OG005 | Part 2: Sisunatovir 50 mg, Formula | Participants tasted sisunatovir 50 mg capsule content in formula and then spat out the drug to assess the palatability. |
| OG006 | Part 2: Sisunatovir 50 mg, Apple Juice | Participants tasted sisunatovir 50 mg capsule content in Apple Juice and then spat out the drug to assess the palatability. |
| OG007 | Part 2: Sisunatovir 50 mg, Saline | Participants tasted sisunatovir 50 mg capsule content in saline and then spat out the drug to assess the palatability. |
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| Primary | 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. | 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. | Posted | Count of Participants | Participants | Up to Day 5 |
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| Primary | 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. | 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. | Posted | Count of Participants | Participants | Up to Day 5 |
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| Primary | 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. | 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. | Posted | Count of Participants | Participants | Up to Day 7 |
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| Secondary | 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. | Pharmacokinetic (PK) parameter analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest could be reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram*hour/ milliliter (ng*hr/mL) | Pre-dose, 1, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day 1 |
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| Secondary | Dose Normalized AUCtau (AUCtau [dn]) for Day 1: Part 1 | AUCtau(dn) was calculated as AUCtau/Dose. | PK parameter analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest could be reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram*hour/ milliliter/milligram | Pre-dose, 1, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day 1 |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) for Day 1: Part 1 | PK parameter analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest could be reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram/milliliter (ng/mL) | Pre-dose, 1, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day 1 |
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| Secondary | Dose Normalized Maximum Plasma Concentration (Cmax [dn]) for Day 1: Part 1 | Cmax(dn) was calculated as Cmax/Dose. | PK parameter analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest could be reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram/milliliter/milligram (ng/mL/mg) | Pre-dose, 1, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day 1 |
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| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) for Day 1: Part 1 | PK parameter analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest could be reported. | Posted | Median | Full Range | Hour | Pre-dose, 1, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day 1 |
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| Secondary | 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. | PK parameter analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest could be reported. Here, Number of Participants Analyzed' signifies participants evaluable for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram*hour/ milliliter (ng*hr/mL) | Pre-dose, 1, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day 5 |
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| Secondary | AUCtau(dn) for Day 5: Part 1 | AUCtau(dn) was calculated as AUCtau/Dose. | PK parameter analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest could be reported. Here, Number of Participants Analyzed' signifies participants evaluable for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram*hour/milliliter/milligram | Pre-dose, 1, 2, 3,4, 5, 6, 8 and 12 hours post-dose on Day 5 |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) for Day 5: Part 1 | PK parameter analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest could be reported. Here, Number of Participants Analyzed' signifies participants evaluable for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram/milliliter (ng/mL) | Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 5 |
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| Secondary | Cmax(dn) for Day 5: Part 1 | Cmax(dn) was calculated as Cmax/Dose. | PK parameter analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest could be reported. Here, Number of Participants Analyzed' signifies participants evaluable for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL/mg | Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 5 |
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| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) for Day 5: Part 1 | PK parameter analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest could be reported. Here, Number of Participants Analyzed' signifies participants evaluable for this outcome. | Posted | Median | Full Range | Hour | Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 5 |
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| Secondary | Apparent Clearance (CL/F) for Day 5: Part 1 | CL/F was calculated as Dose/AUCtau. | PK parameter analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest could be reported. Here, Number of Participants Analyzed' signifies participants evaluable for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter/hour | Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 5 |
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| Secondary | Observed Accumulation Ratio (Rac) for AUC for Day 5: Part 1 | Rac for AUC was calculated as AUCtau Day5/AUCtau Day1. | PK parameter analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest could be reported. Here, Number of Participants Analyzed' signifies participants evaluable for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio | 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 |
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| Secondary | Observed Accumulation Ratio for Maximum Observed Plasma Concentration (Rac,Cmax) for Day 5: Part 1 | Rac,Cmax was calculated as Cmax Day5/Cmax Day1. | PK parameter analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest could be reported. Here, Number of Participants Analyzed' signifies participants evaluable for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio | 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 |
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| Secondary | Plasma Decay Half-Life (t1/2) for Day 5: Part 1 | PK parameter analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest could be reported. Here, Number of Participants Analyzed' signifies participants evaluable for this outcome. | Posted | Mean | Standard Deviation | Hour | Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 5 |
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| Secondary | Apparent Volume of Distribution (Vz/F) for Day 5: Part 1 | Vz/F was calculated as Dose/(AUCtau * kel [Terminal phase rate constant]). | PK parameter analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest could be reported. Here, Number of Participants Analyzed' signifies participants evaluable for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter | Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 5 |
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| Secondary | AUCtau for Day 5: Evaluation of Food Effect (Sisunatovir 200 mg Fed Versus Fasted): Part 1 | PK parameter analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest could be reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12 hours post-dose on Day 5 |
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| Secondary | Cmax for Day 5: Evaluation of Food Effect (Sisunatovir 200 mg Fed Versus Fasted): Part 1 | PK parameter analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest could be reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 5 |
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| Secondary | 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. | 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. | Posted | Mean | 90% Confidence Interval | Units on a scale | 1 minute (immediately following dose), 5,10 and 20 minutes after tasting dose in each vehicle |
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| Secondary | 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. | 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. | Posted | Mean | 90% Confidence Interval | Units on a scale | 1 minute (immediately following dose), 5,10 and 20 minutes after tasting dose in each vehicle |
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| Secondary | 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. | 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. | Posted | Mean | 90% Confidence Interval | Units on a scale | 1 minute (immediately following dose), 5,10 and 20 minutes after tasting dose in each vehicle |
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| Secondary | 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. | 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. | Posted | Mean | 90% Confidence Interval | Units on a scale | 1 minute (immediately following dose), 5,10 and 20 minutes after tasting dose in each vehicle |
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| Secondary | 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. | 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. | Posted | Mean | 90% Confidence Interval | Units on a scale | 1 minute (immediately following dose), 5,10 and 20 minutes after tasting dose in each vehicle |
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| Secondary | 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. | 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. | Posted | Mean | 90% Confidence Interval | Units on a scale | 1 minute (immediately following dose), 5,10 and 20 minutes after tasting dose in each vehicle |
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| Secondary | 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. | 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. | Posted | Mean | 90% Confidence Interval | Units on a scale | 1 minute (immediately following dose), 5,10 and 20 minutes after tasting dose in each vehicle |
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| 0 |
| 6 |
| 0 |
| 6 |
| 6 |
| 6 |
| EG001 | Part 1: Sisunatovir 200 mg, Fed | Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1. | 0 | 12 | 0 | 12 | 7 | 12 |
| EG002 | Part 1: Placebo, Fed | Participants were administered placebo once every 12 hours for 4 days plus 1 dose in a fed state in either period 1 or 2 of Part 1. | 0 | 6 | 0 | 6 | 4 | 6 |
| EG003 | Part 1: Sisunatovir 200 mg, Fasted | Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose in a fasted state in period 3 of Part 1. | 0 | 11 | 0 | 11 | 9 | 11 |
| EG004 | Part 2: Sisunatovir 50 mg, Water | Participants tasted sisunatovir 50 mg capsule content in water and then spat out the drug to assess the palatability. | 0 | 11 | 0 | 11 | 2 | 11 |
| EG005 | Part 2: Sisunatovir 50 mg, Formula | Participants tasted sisunatovir 50 mg capsule content in formula and then spat out the drug to assess the palatability. | 0 | 11 | 0 | 11 | 1 | 11 |
| EG006 | Part 2: Sisunatovir 50 mg, Apple Juice | Participants tasted sisunatovir 50 mg capsule content in Apple Juice and then spat out the drug to assess the palatability. | 0 | 11 | 0 | 11 | 0 | 11 |
| EG007 | Part 2: Sisunatovir 50 mg, Saline | Participants tasted sisunatovir 50 mg capsule content in saline and then spat out the drug to assess the palatability. | 0 | 11 | 0 | 11 | 2 | 11 |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Abnormal faeces | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Frequent bowel movements | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Lip dry | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Oesophageal pain | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Feeling drunk | General disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Folliculitis | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
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| Limb injury | Injury, poisoning and procedural complications | MedDRA v26.0 | Non-systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
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| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Dizziness postural | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Bradyphrenia | Psychiatric disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Nightmare | Psychiatric disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Polyuria | Renal and urinary disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Eczema nummular | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Keratosis pilaris | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA v26.0 | Non-systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center 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.
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