Trial Outcomes & Findings for A Study to Learn How the Study Medicine Called Sisunatovir is Tolerated and Acts in the Bodies of Chinese Healthy Adults. (NCT NCT05987072)

Results Overview

Cmax was defined as maximum observed plasma concentration. Cmax was observed directly from data.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

12 participants

Primary outcome timeframe

0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72 hours post dose on Day1

Results posted on

2025-02-24

Participant Flow

Twelve participants were enrolled and treated in the study.

Follow-up occurred via telephone contact and must occur 28 to 35 days after administration of the last dose of study intervention.

Participant milestones

Participant milestones
Measure	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.
Treatment Period (Day -1 to Day 11) STARTED	12
Treatment Period (Day -1 to Day 11) Received Treatment	12
Treatment Period (Day -1 to Day 11) COMPLETED	12
Treatment Period (Day -1 to Day 11) NOT COMPLETED	0
FOLLOW-UP STARTED	12
FOLLOW-UP Received Treatment	12
FOLLOW-UP COMPLETED	12
FOLLOW-UP NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Learn How the Study Medicine Called Sisunatovir is Tolerated and Acts in the Bodies of Chinese Healthy Adults.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sisunatovir 200 mg n=12 Participants 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.
Age, Continuous	27.4 Years STANDARD_DEVIATION 4.89 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	12 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Not Hispanic or Latino	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Cmax was defined as maximum observed plasma concentration. Cmax was observed directly from data.

Outcome measures

Outcome measures
Measure	Sisunatovir 200 mg n=11 Participants 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.
Maximum Observed Plasma Concentration (Cmax) of Sisunatovir on Day 1	80.14 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 73

PRIMARY outcome

Timeframe: 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.

Cmax was defined as maximum observed plasma concentration.

Outcome measures

Outcome measures
Measure	Sisunatovir 200 mg n=12 Participants 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.
Maximum Observed Plasma Concentration (Cmax) of Sisunatovir on Day 4	115.5 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 59

PRIMARY outcome

Timeframe: 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.

Cmax was defined as maximum observed plasma concentration.

Outcome measures

Outcome measures
Measure	Sisunatovir 200 mg n=12 Participants 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.
Maximum Observed Plasma Concentration (Cmax) of Sisunatovir on Day 8	198.7 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 51

PRIMARY outcome

Timeframe: 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.

AUC12 was defined as area under the concentration-time curve from time zero to 12 hours.

Outcome measures

Outcome measures
Measure	Sisunatovir 200 mg n=11 Participants 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.
Area Under the Plasma Concentration-time Profile From Time Zero to Time 12 Hours (AUC12) of Sisunatovir on Day 1	470.6 nanogramhour per milliliter (nghr/mL) Geometric Coefficient of Variation 71

PRIMARY outcome

Timeframe: 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.

AUC12 was defined as area under the concentration-time curve from time zero to 12 hours.

Outcome measures

Outcome measures
Measure	Sisunatovir 200 mg n=12 Participants 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.
Area Under the Plasma Concentration-time Profile From Time Zero to Time 12 Hours (AUC12) of Sisunatovir on Day 4	602.3 nanogramhour per milliliter (nghr/mL) Geometric Coefficient of Variation 60

PRIMARY outcome

Timeframe: 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.

AUC12 was defined as area under the concentration-time curve from time zero to 12 hours.

Outcome measures

Outcome measures
Measure	Sisunatovir 200 mg n=12 Participants 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.
Area Under the Plasma Concentration-time Profile From Time Zero to Time 12 Hours (AUC12) of Sisunatovir on Day 8	1295 nanogramhour per milliliter (nghr/mL) Geometric Coefficient of Variation 65

PRIMARY outcome

Timeframe: 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.

AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.

Outcome measures

Outcome measures
Measure	Sisunatovir 200 mg n=11 Participants 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.
Area Under the Plasma Concentration-time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of Sisunatovir on Day1	708.8 nanogramhour per milliliter (nghr/mL) Geometric Coefficient of Variation 78

PRIMARY outcome

Timeframe: 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.

AUCinf was defined as area under the concentration-time curve from time 0 to infinity.

Outcome measures

Outcome measures
Measure	Sisunatovir 200 mg n=11 Participants 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.
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) on Day1	757.3 nanogramhour per milliliter (nghr/mL) Geometric Coefficient of Variation 70

SECONDARY outcome

Timeframe: 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.

Tmax was defined as time to reach Cmax.

Outcome measures

Outcome measures
Measure	Sisunatovir 200 mg n=12 Participants 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.
Time to Reach Cmax (Tmax) on Day 1, Day 4 and Day 8 Day 4	5.00 hr (hour) Interval 3.0 to 6.0
Time to Reach Cmax (Tmax) on Day 1, Day 4 and Day 8 Day 8	5.00 hr (hour) Interval 3.0 to 6.0
Time to Reach Cmax (Tmax) on Day 1, Day 4 and Day 8 Day 1	5.00 hr (hour) Interval 2.0 to 5.0

SECONDARY outcome

Timeframe: 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.

t½ was defined as terminal elimination half-life.

Outcome measures

Outcome measures
Measure	Sisunatovir 200 mg n=12 Participants 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.
Terminal Elimination Half-life (t½) on Day 1 and Day 8 Day 1	9.495 hr (hour) Standard Deviation 1.5588
Terminal Elimination Half-life (t½) on Day 1 and Day 8 Day 8	10.40 hr (hour) Standard Deviation 1.2316

SECONDARY outcome

Timeframe: 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.

Rac is defined as: Observed accumulation ratio for AUCtau. Accumulation ratio on AUCtau = AUC12 (Day 8) /AUC12 (Day 4)

Outcome measures

Outcome measures
Measure	Sisunatovir 200 mg n=12 Participants 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.
Accumulation Ratio for Sisunatovir (Rac)	2.149 ratio Geometric Coefficient of Variation 29

SECONDARY outcome

Timeframe: 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.

Accumulation ratio on Cmax =Cmax (Day 8) /Cmax (Day 4)

Outcome measures

Outcome measures
Measure	Sisunatovir 200 mg n=12 Participants 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.
Accumulation Ratio on Cmax for Sisunatovir (Rac, Cmax)	1.720 ratio Geometric Coefficient of Variation 26

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Sisunatovir 200 mg n=12 Participants 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.
Number of Participants With All-Causality and Treatment-Related Treatment-emergent Adverse Events (TEAEs) Participants with all-causality TEAEs	7 Participants
Number of Participants With All-Causality and Treatment-Related Treatment-emergent Adverse Events (TEAEs) Participants with all-causality SAEs	0 Participants
Number of Participants With All-Causality and Treatment-Related Treatment-emergent Adverse Events (TEAEs) Participants with treatment related TEAEs	6 Participants
Number of Participants With All-Causality and Treatment-Related Treatment-emergent Adverse Events (TEAEs) Participants with treatment related SAEs	0 Participants

SECONDARY outcome

Timeframe: Baseline up to Day 11 (11 days)

Population: The analysis population included all participants who took at least 1 dose of study intervention.

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.

Outcome measures

Outcome measures
Measure	Sisunatovir 200 mg n=12 Participants 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.
Number of Participants With Vital Signs Meeting the Pre-specified Criteria supine systolic BP value<90 mmHg	0 Participants
Number of Participants With Vital Signs Meeting the Pre-specified Criteria supine systolic BP decrease≥ 30 mmHg	1 Participants
Number of Participants With Vital Signs Meeting the Pre-specified Criteria supine diastolic BP value< 50mmHg	0 Participants
Number of Participants With Vital Signs Meeting the Pre-specified Criteria supine diastolic BP increase≥ 20mmHg	0 Participants
Number of Participants With Vital Signs Meeting the Pre-specified Criteria supine diastolic BP decrease≥ 20mmHg	1 Participants
Number of Participants With Vital Signs Meeting the Pre-specified Criteria pulse rate value<40 bpm	0 Participants
Number of Participants With Vital Signs Meeting the Pre-specified Criteria pulse rate value>120 bpm	0 Participants
Number of Participants With Vital Signs Meeting the Pre-specified Criteria supine systolic BP increase≥ 30 mmHg	0 Participants

SECONDARY outcome

Timeframe: Baseline up to Day 11 (11 days)

Population: The analysis population included all participants who took at least 1 dose of study intervention.

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.

Outcome measures

Outcome measures
Measure	Sisunatovir 200 mg n=12 Participants 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.
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	0 Participants

SECONDARY outcome

Timeframe: Baseline up to Day 11 (11 days)

Population: The analysis population included all participants who took at least 1 dose of study intervention.

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.

Outcome measures

Outcome measures
Measure	Sisunatovir 200 mg n=12 Participants 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.
Number of Participants With Electrocardiogram (ECG) Abnormalities	0 Participants

Adverse Events

Sisunatovir 200 mg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Sisunatovir 200 mg n=12 participants at risk 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.
Gastrointestinal disorders Abdominal distension	8.3% 1/12 • From the first dose (Day 1) up to 35 days after the last dose (Day 8) of study intervention (up to 43 days)
Gastrointestinal disorders Diarrhoea	25.0% 3/12 • From the first dose (Day 1) up to 35 days after the last dose (Day 8) of study intervention (up to 43 days)
Gastrointestinal disorders Nausea	16.7% 2/12 • From the first dose (Day 1) up to 35 days after the last dose (Day 8) of study intervention (up to 43 days)
Gastrointestinal disorders Vomiting	8.3% 1/12 • From the first dose (Day 1) up to 35 days after the last dose (Day 8) of study intervention (up to 43 days)
General disorders Chest discomfort	8.3% 1/12 • From the first dose (Day 1) up to 35 days after the last dose (Day 8) of study intervention (up to 43 days)
Infections and infestations Upper respiratory tract infection	8.3% 1/12 • From the first dose (Day 1) up to 35 days after the last dose (Day 8) of study intervention (up to 43 days)

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER