Respiratory Syncytial Virus Infection
Conditions
Brief summary
The purpose of the study is to learn about: * The activity of sisunotavir in the body over a period. It includes the processes by which sisunotavir is absorbed, distributed in the body, localized in the tissues, and removed from the body. * safety and tolerability of sisunatovir (PF-07923568) in Chinese healthy adult participants. This information is being collected to support further clinical development as well as medicine registration in China. This study is seeking for participants who: * are male and female participants aged 18 to 65 years of age. * are male and female participants who are healthy as seen by medical tests. * have body mass index (BMI) of 19 to 27 kg/m2 and a total body weight of more than 50 kilograms (110 pounds). About 12 participants will receive sisunatovir. Four capsules (strength=50 milligrams, 200 milligrams in total) of Sisunatovir will be given on Day 1 on empty stomach. This will be followed by 8 capsules of sisunatovir with 12 hours gap in between four capsules from Days 4 to 7. The participants will have to take 4 capsules of sisunatovir in the morning of 8th day with a meal. The total time of participants will be in the study is about 71 days. This includes the screening visit to the Follow-up contact. In screening visit, participants will be tested to see if they are fit to take part in the study.
Interventions
DRUGSisunatovir
Will be given as a single dose on Day 1 in a fasted state followed by repeated twice daily doses (200 mg BID, Q12 hours) from Days 4-7 plus 1 morning dose on Day 8 in a fed state
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
single-arm to investigate PK, safety and tolerability of 200 mg sisunatovir given as a single dose on Day 1 in a fasted state followed by repeated twice daily doses (200 mg BID, Q12 hours) from Days 4-7 plus 1 morning dose on Day 8 in a fed state in Chinese healthy participants.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Chinese male and female 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, standard 12-lead ECG, and laboratory tests. * Body mass index (BMI) of 19 to 27 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). * Any 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 cytochrome P4503A (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 (eg, QTc corrected using Fridericia's formula \[QTcF\] \>450 ms, complete left bundle branch block \[LBBB\], signs of an acute or indeterminate- age myocardial infarction, ST-segment and T-wave \[ST-T\] interval changes suggestive of myocardial ischemia, second- or thirddegree AV block, or serious bradyarrhythmias or tachyarrhythmias). If the uncorrected QT interval is \>450 ms, this interval should be rate-corrected using the Fridericia method only and the resulting QTcF should be used for decision making and reporting. If QTcF exceeds 450 ms, or quantitative restrictions (QRS) exceeds 120 ms, the ECG should be repeated twice and the average of the 3 QTcF or QRS values used to determine the participant's eligibility. Computer interpreted- ECGs should be overread by a physician experienced in reading ECGs before excluding a participant. * 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 chronic kidney disease epidemiology (CKD-EPI equation); * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≥1.05 × upper limit of normal (ULN); * Gamma-glutamyl transferase (GGT) \> 1.05 × ULN; * Alkaline phosphatase \> 1.05 × ULN; * Total bilirubin level ≥1.05 × 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) on Day1 | 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72 hours post dose on Day1 | AUCinf was defined as area under the concentration-time curve from time 0 to infinity. |
| Maximum Observed Plasma Concentration (Cmax) of Sisunatovir on Day 1 | 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72 hours post dose on Day1 | Cmax was defined as maximum observed plasma concentration. Cmax was observed directly from data. |
| Maximum Observed Plasma Concentration (Cmax) of Sisunatovir on Day 4 | 0, 1, 2, 3, 4, 5, 6, 8, 10, 12 hours post dose on Day 4 | Cmax was defined as maximum observed plasma concentration. |
| Maximum Observed Plasma Concentration (Cmax) of Sisunatovir on Day 8 | 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72 hours post dose on Day 8 | Cmax was defined as maximum observed plasma concentration. |
| Area Under the Plasma Concentration-time Profile From Time Zero to Time 12 Hours (AUC12) of Sisunatovir on Day 1 | 0, 1, 2, 3, 4, 5, 6, 8, 10, 12 hours post dose on Day1 | AUC12 was defined as area under the concentration-time curve from time zero to 12 hours. |
| Area Under the Plasma Concentration-time Profile From Time Zero to Time 12 Hours (AUC12) of Sisunatovir on Day 4 | 0, 1, 2, 3, 4, 5, 6, 8, 10, 12 hours post dose on Day 4 | AUC12 was defined as area under the concentration-time curve from time zero to 12 hours. |
| Area Under the Plasma Concentration-time Profile From Time Zero to Time 12 Hours (AUC12) of Sisunatovir on Day 8 | 0, 1, 2, 3, 4, 5, 6, 8, 10, 12 hours post dose on Day 8 | AUC12 was defined as area under the concentration-time curve from time zero to 12 hours. |
| Area Under the Plasma Concentration-time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of Sisunatovir on Day1 | 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72 hours post dose on Day1 | AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Reach Cmax (Tmax) on Day 1, Day 4 and Day 8 | 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72 hours post dose on Day1, and Day 8. 0, 1, 2, 3, 4, 5, 6, 8, 10, 12 hours post dose on Day 4. | Tmax was defined as time to reach Cmax. |
| Terminal Elimination Half-life (t½) on Day 1 and Day 8 | 0, 1, 2, 3, 4, 5, 6, 8, 10, 12,14, 24, 48, 72 hours post dose on Day1, and Day 8 | t½ was defined as terminal elimination half-life. |
| Accumulation Ratio for Sisunatovir (Rac) | 0, 1, 2, 3, 4, 5, 6, 8, 10, 12 hours post dose on Day 4 and Day 8 | Rac is defined as: Observed accumulation ratio for AUCtau. Accumulation ratio on AUCtau = AUC12 (Day 8) /AUC12 (Day 4) |
| Accumulation Ratio on Cmax for Sisunatovir (Rac, Cmax) | 0, 1, 2, 3, 4, 5, 6, 8, 10, 12 hours post dose on Day 4 and 0, 1, 2, 3, 4, 5, 6, 8, 10, 12,14, 24, 48, 72 hours post dose on Day 8 | Accumulation ratio on Cmax =Cmax (Day 8) /Cmax (Day 4) |
| Number of Participants With All-Causality and Treatment-Related Treatment-emergent Adverse Events (TEAEs) | From the first dose (Day 1) up to 35 days after the last dose (Day 8) of study intervention (up to 43 days) | An AE is any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship with the study intervention. SAE is defined as one of the following: is fatal or life threatening; results in persistent or significant disability/incapacity; constitutes a congenital anomaly/birth defect; is medically significant; requires inpatient hospitalization or prolongation of existing hospitalization. Treatment-emergent AE is defined as an AE with onset date occurring during the on-treatment period. AEs include all SAEs and non-SAEs. |
| Number of Participants With Vital Signs Meeting the Pre-specified Criteria | Baseline up to Day 11 (11 days) | Blood pressure (BP) and pulse rate were obtained with participant following at least a 5-minute rest in a supine position. Clinical significance of vital signs was determined at the investigator's discretion. |
| Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | Baseline up to Day 11 (11 days) | Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, platelet, neutrophils, eosinophils, monocytes, basophils, lymphocytes, leukocytes); clinical chemistry (alanine aminotransferase, albumin, alkaline phosphatase, bilirubin, calcium, carbon dioxide combining power, chloride, creatinine, cystatin C, GFR CKD-EPI serum creatinine 2021, gamma glutamyl transferase, glucose, potassium, sodium, urate, urea). urinalysis (Bilirubin, Glucose, Hemoglobin, Ketones, Leukocyte Esterase, Nitrite, Protein, Urobilinogen, pH).0 indicates no participants with abnormalities of all above lab examination. |
| Number of Participants With Electrocardiogram (ECG) Abnormalities | Baseline up to Day 11 (11 days) | Criteria for ECG abnormalities: maximum PR interval \>=300 milliseconds (msec) and maximum increase PR interval increase from baseline (IFB): percent change (Pctchg) \>=25 percent (%) for baseline value of \>200 msec and Pctchg\>=50% for baseline value of \<=200 msec for PR interval, maximum QRS interval \>=140 msec and a maximum IFB: Pctchg\>=50%, maximum QTCF interval (Fridericia's Correction) of 450 msec to \<480 msec, 480 msec to \<500 msec or \>=500 msec and a maximum change of \<=30change\<60 or \>=60 msec from baseline. |
Countries
China
Participant flow
Recruitment details
Twelve participants were enrolled and treated in the study.
Pre-assignment details
Follow-up occurred via telephone contact and must occur 28 to 35 days after administration of the last dose of study intervention.
Participants by arm
| Arm | Count |
|---|---|
| Sisunatovir 200 mg Participants received a single oral dose of sisunatovir 200 mg on Day 1 in a fasted state followed by repeated twice daily doses (200 mg BID, every 12 hours \[Q12 hours\]) from Days 4-7 plus 1 morning dose on Day 8 in a fed state. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Sisunatovir 200 mg |
|---|---|
| Age, Continuous | 27.4 Years STANDARD_DEVIATION 4.89 |
| Race/Ethnicity, Customized Ethnicity Not Hispanic or Latino | 12 Participants |
| Race/Ethnicity, Customized Race Asian | 12 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 7 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) on Day1
AUCinf was defined as area under the concentration-time curve from time 0 to infinity.
Time frame: 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72 hours post dose on Day1
Population: Analysis population included all participants who take at least 1 dose of study intervention and have at least 1 of the PK parameters of interest calculated. One participant had emesis on Day 1 and therefore was excluded from the summaries.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Sisunatovir 200 mg | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) on Day1 | 757.3 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 70 |
Primary
Area Under the Plasma Concentration-time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of Sisunatovir on Day1
AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.
Time frame: 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72 hours post dose on Day1
Population: Analysis population included all participants who take at least 1 dose of study intervention and have at least 1 of the PK parameters of interest calculated. One participant had emesis on Day 1 and therefore was excluded from the summaries.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Sisunatovir 200 mg | Area Under the Plasma Concentration-time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of Sisunatovir on Day1 | 708.8 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 78 |
Primary
Area Under the Plasma Concentration-time Profile From Time Zero to Time 12 Hours (AUC12) of Sisunatovir on Day 1
AUC12 was defined as area under the concentration-time curve from time zero to 12 hours.
Time frame: 0, 1, 2, 3, 4, 5, 6, 8, 10, 12 hours post dose on Day1
Population: Analysis population included all participants who take at least 1 dose of study intervention and have at least 1 of the PK parameters of interest calculated. One participant had emesis on Day 1 and therefore was excluded from the summaries.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Sisunatovir 200 mg | Area Under the Plasma Concentration-time Profile From Time Zero to Time 12 Hours (AUC12) of Sisunatovir on Day 1 | 470.6 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 71 |
Primary
Area Under the Plasma Concentration-time Profile From Time Zero to Time 12 Hours (AUC12) of Sisunatovir on Day 4
AUC12 was defined as area under the concentration-time curve from time zero to 12 hours.
Time frame: 0, 1, 2, 3, 4, 5, 6, 8, 10, 12 hours post dose on Day 4
Population: Analysis population included all participants who take at least 1 dose of study intervention and have at least 1 of the PK parameters of interest calculated.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Sisunatovir 200 mg | Area Under the Plasma Concentration-time Profile From Time Zero to Time 12 Hours (AUC12) of Sisunatovir on Day 4 | 602.3 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 60 |
Primary
Area Under the Plasma Concentration-time Profile From Time Zero to Time 12 Hours (AUC12) of Sisunatovir on Day 8
AUC12 was defined as area under the concentration-time curve from time zero to 12 hours.
Time frame: 0, 1, 2, 3, 4, 5, 6, 8, 10, 12 hours post dose on Day 8
Population: Analysis population included all participants who take at least 1 dose of study intervention and have at least 1 of the PK parameters of interest calculated.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Sisunatovir 200 mg | Area Under the Plasma Concentration-time Profile From Time Zero to Time 12 Hours (AUC12) of Sisunatovir on Day 8 | 1295 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 65 |
Primary
Maximum Observed Plasma Concentration (Cmax) of Sisunatovir on Day 1
Cmax was defined as maximum observed plasma concentration. Cmax was observed directly from data.
Time frame: 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72 hours post dose on Day1
Population: Analysis population included all participants who take at least 1 dose of study intervention and in whom at least 1 plasma concentration value is reported. One participant had emesis on Day 1 and therefore was excluded from the summaries.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Sisunatovir 200 mg | Maximum Observed Plasma Concentration (Cmax) of Sisunatovir on Day 1 | 80.14 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 73 |
Primary
Maximum Observed Plasma Concentration (Cmax) of Sisunatovir on Day 4
Cmax was defined as maximum observed plasma concentration.
Time frame: 0, 1, 2, 3, 4, 5, 6, 8, 10, 12 hours post dose on Day 4
Population: Analysis population included all participants who take at least 1 dose of study intervention and in whom at least 1 plasma concentration value is reported.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Sisunatovir 200 mg | Maximum Observed Plasma Concentration (Cmax) of Sisunatovir on Day 4 | 115.5 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 59 |
Primary
Maximum Observed Plasma Concentration (Cmax) of Sisunatovir on Day 8
Cmax was defined as maximum observed plasma concentration.
Time frame: 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72 hours post dose on Day 8
Population: Analysis population included all participants who take at least 1 dose of study intervention and in whom at least 1 plasma concentration value is reported.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Sisunatovir 200 mg | Maximum Observed Plasma Concentration (Cmax) of Sisunatovir on Day 8 | 198.7 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 51 |
Secondary
Accumulation Ratio for Sisunatovir (Rac)
Rac is defined as: Observed accumulation ratio for AUCtau. Accumulation ratio on AUCtau = AUC12 (Day 8) /AUC12 (Day 4)
Time frame: 0, 1, 2, 3, 4, 5, 6, 8, 10, 12 hours post dose on Day 4 and Day 8
Population: Analysis population included all participants who take at least 1 dose of study intervention and have at least 1 of the PK parameters of interest calculated.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Sisunatovir 200 mg | Accumulation Ratio for Sisunatovir (Rac) | 2.149 ratio | Geometric Coefficient of Variation 29 |
Secondary
Accumulation Ratio on Cmax for Sisunatovir (Rac, Cmax)
Accumulation ratio on Cmax =Cmax (Day 8) /Cmax (Day 4)
Time frame: 0, 1, 2, 3, 4, 5, 6, 8, 10, 12 hours post dose on Day 4 and 0, 1, 2, 3, 4, 5, 6, 8, 10, 12,14, 24, 48, 72 hours post dose on Day 8
Population: Analysis population included all participants who take at least 1 dose of study intervention and have at least 1 of the PK parameters of interest calculated.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Sisunatovir 200 mg | Accumulation Ratio on Cmax for Sisunatovir (Rac, Cmax) | 1.720 ratio | Geometric Coefficient of Variation 26 |
Secondary
Number of Participants With All-Causality and Treatment-Related Treatment-emergent Adverse Events (TEAEs)
An AE is any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship with the study intervention. SAE is defined as one of the following: is fatal or life threatening; results in persistent or significant disability/incapacity; constitutes a congenital anomaly/birth defect; is medically significant; requires inpatient hospitalization or prolongation of existing hospitalization. Treatment-emergent AE is defined as an AE with onset date occurring during the on-treatment period. AEs include all SAEs and non-SAEs.
Time frame: From the first dose (Day 1) up to 35 days after the last dose (Day 8) of study intervention (up to 43 days)
Population: The analysis population included all participants who took at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sisunatovir 200 mg | Number of Participants With All-Causality and Treatment-Related Treatment-emergent Adverse Events (TEAEs) | Participants with all-causality TEAEs | 7 Participants |
| Sisunatovir 200 mg | Number of Participants With All-Causality and Treatment-Related Treatment-emergent Adverse Events (TEAEs) | Participants with all-causality SAEs | 0 Participants |
| Sisunatovir 200 mg | Number of Participants With All-Causality and Treatment-Related Treatment-emergent Adverse Events (TEAEs) | Participants with treatment related TEAEs | 6 Participants |
| Sisunatovir 200 mg | Number of Participants With All-Causality and Treatment-Related Treatment-emergent Adverse Events (TEAEs) | Participants with treatment related SAEs | 0 Participants |
Secondary
Number of Participants With Electrocardiogram (ECG) Abnormalities
Criteria for ECG abnormalities: maximum PR interval \>=300 milliseconds (msec) and maximum increase PR interval increase from baseline (IFB): percent change (Pctchg) \>=25 percent (%) for baseline value of \>200 msec and Pctchg\>=50% for baseline value of \<=200 msec for PR interval, maximum QRS interval \>=140 msec and a maximum IFB: Pctchg\>=50%, maximum QTCF interval (Fridericia's Correction) of 450 msec to \<480 msec, 480 msec to \<500 msec or \>=500 msec and a maximum change of \<=30change\<60 or \>=60 msec from baseline.
Time frame: Baseline up to Day 11 (11 days)
Population: The analysis population included all participants who took at least 1 dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sisunatovir 200 mg | Number of Participants With Electrocardiogram (ECG) Abnormalities | 0 Participants |
Secondary
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, platelet, neutrophils, eosinophils, monocytes, basophils, lymphocytes, leukocytes); clinical chemistry (alanine aminotransferase, albumin, alkaline phosphatase, bilirubin, calcium, carbon dioxide combining power, chloride, creatinine, cystatin C, GFR CKD-EPI serum creatinine 2021, gamma glutamyl transferase, glucose, potassium, sodium, urate, urea). urinalysis (Bilirubin, Glucose, Hemoglobin, Ketones, Leukocyte Esterase, Nitrite, Protein, Urobilinogen, pH).0 indicates no participants with abnormalities of all above lab examination.
Time frame: Baseline up to Day 11 (11 days)
Population: The analysis population included all participants who took at least 1 dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sisunatovir 200 mg | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | 0 Participants |
Secondary
Number of Participants With Vital Signs Meeting the Pre-specified Criteria
Blood pressure (BP) and pulse rate were obtained with participant following at least a 5-minute rest in a supine position. Clinical significance of vital signs was determined at the investigator's discretion.
Time frame: Baseline up to Day 11 (11 days)
Population: The analysis population included all participants who took at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sisunatovir 200 mg | Number of Participants With Vital Signs Meeting the Pre-specified Criteria | supine systolic BP value<90 mmHg | 0 Participants |
| Sisunatovir 200 mg | Number of Participants With Vital Signs Meeting the Pre-specified Criteria | supine systolic BP increase≥ 30 mmHg | 0 Participants |
| Sisunatovir 200 mg | Number of Participants With Vital Signs Meeting the Pre-specified Criteria | supine systolic BP decrease≥ 30 mmHg | 1 Participants |
| Sisunatovir 200 mg | Number of Participants With Vital Signs Meeting the Pre-specified Criteria | supine diastolic BP value< 50mmHg | 0 Participants |
| Sisunatovir 200 mg | Number of Participants With Vital Signs Meeting the Pre-specified Criteria | supine diastolic BP increase≥ 20mmHg | 0 Participants |
| Sisunatovir 200 mg | Number of Participants With Vital Signs Meeting the Pre-specified Criteria | supine diastolic BP decrease≥ 20mmHg | 1 Participants |
| Sisunatovir 200 mg | Number of Participants With Vital Signs Meeting the Pre-specified Criteria | pulse rate value<40 bpm | 0 Participants |
| Sisunatovir 200 mg | Number of Participants With Vital Signs Meeting the Pre-specified Criteria | pulse rate value>120 bpm | 0 Participants |
Secondary
Terminal Elimination Half-life (t½) on Day 1 and Day 8
t½ was defined as terminal elimination half-life.
Time frame: 0, 1, 2, 3, 4, 5, 6, 8, 10, 12,14, 24, 48, 72 hours post dose on Day1, and Day 8
Population: Analysis population included all participants who take at least 1 dose of study intervention and have at least 1 of the PK parameters of interest calculated. One participant had emesis on Day 1 and therefore was excluded from the summaries of Day 1.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sisunatovir 200 mg | Terminal Elimination Half-life (t½) on Day 1 and Day 8 | Day 1 | 9.495 hr (hour) | Standard Deviation 1.5588 |
| Sisunatovir 200 mg | Terminal Elimination Half-life (t½) on Day 1 and Day 8 | Day 8 | 10.40 hr (hour) | Standard Deviation 1.2316 |
Secondary
Time to Reach Cmax (Tmax) on Day 1, Day 4 and Day 8
Tmax was defined as time to reach Cmax.
Time frame: 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72 hours post dose on Day1, and Day 8. 0, 1, 2, 3, 4, 5, 6, 8, 10, 12 hours post dose on Day 4.
Population: Analysis population included all participants who take at least 1 dose of study intervention and have at least 1 of the PK parameters of interest calculated. One participant had emesis on Day 1 and therefore was excluded from the summaries of Day 1.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Sisunatovir 200 mg | Time to Reach Cmax (Tmax) on Day 1, Day 4 and Day 8 | Day 1 | 5.00 hr (hour) |
| Sisunatovir 200 mg | Time to Reach Cmax (Tmax) on Day 1, Day 4 and Day 8 | Day 4 | 5.00 hr (hour) |
| Sisunatovir 200 mg | Time to Reach Cmax (Tmax) on Day 1, Day 4 and Day 8 | Day 8 | 5.00 hr (hour) |