sisunatovir
DrugWill 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
NCT Number: NCT05987072
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.
Looking for future studies?
Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Huashan Hospital, Shanghai, Shanghai Municipality, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 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.
Time frame: 0, 1, 2, 3, 4, 5, 6, 8, 10, 12 hours post dose on Day 4
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
Cmax was defined as maximum observed plasma concentration.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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.
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
t½ was defined as terminal elimination half-life.
Time frame: 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)
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
Accumulation ratio on Cmax =Cmax (Day 8) /Cmax (Day 4)
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)
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: 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.
Time frame: 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.
Time frame: 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.
Pfizer
Industry
A PHASE 1, OPEN-LABEL, SINGLE-ARM STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY, AND TOLERABILITY FOLLOWING SINGLE AND MULTIPLE DOSES OF SISUNATOVIR IN CHINESE HEALTHY PARTICIPANTS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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