New Haven Clinical Research Unit
New Haven, Connecticut, 06511, United States
NCT Number: NCT05878522
The purpose of the study is to investigate the effects of multiple oral doses of sisunatovir on QTc Interval.
This study is seeking participants who:
* are male or female of 18 years of age or older * are examined to be healthy All participants will receive Treatment A, B, and C in a randomized order based on 6 possible sequences. All treatments will be taken by mouth. Participants assigned to treatment A will receive 5 oral doses of sisunatovir administered Q12 hours over 3 days in a fed state. Participants assigned to treatment B will receive 5 oral doses of matching placebo administered Q12 hours over 3 days in a fed state. Participants assigned to treatment C will receive 4 oral doses of placebo administered Q12 hours for 2 days followed by a single dose of 400 mg moxifloxacin on the morning of Day 3.
All participants will remain in the study clinic for 4 days for each treatment, for safety review, laboratory collections, and to assess how the study medicine affects QTc intervals.
All participants selected in the study will be required to go through a screening period up to 28 days. A screening period is the time during which a few participants are examined to see whether they are fit for the study. During this period, the participant's medical history and past and current medications will be reviewed. A series of tests will also be performed to see if they are good to be selected for the study. If the participant meets all required criteria and are interested in continuing, the participant will be brought into the study clinic to stay overnight for 4 days for each treatment. On day 4, the participant will be discharged. About 28 to 35 days after discharge following the final treatment, the participant will be contacted for a follow up visit either in person or by telephone. This is to check up on how the participant is doing and to conclude the study.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
New Haven, Connecticut, 06511, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for healthy volunteers:
--Exclusion criteria for all participants:
6 capsules administered Q12 hours for 5 doses
Other names: PF-07923568
6 capsules administered Q12 hours for 5 doses
6 capsules of placebo administered Q12 hours for 4 doses, followed by a single tablet of moxifloxacin
Time frame: Baseline, Day 3
The relationship between sisunatovir plasma concentration and change from baseline in Fridericia's heart-rate corrected QT interval were analyzed using a model-based concentration-QTc analysis consistent with the Scientific White Paper on Concentration-QT Modeling. Baseline was defined as the mean of the 3 averages of the triplicate electrocardiogram (ECG) measurements taken before dosing on Day 1 within each period. Mean and CI statistics were based on the individual (within subject) corrected differences between sisunatovir and placebo exposures.
Time frame: From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An adverse event was considered a Treatment-Emergent Adverse Event (TEAE) if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time but before the end of the study were considered as TEAEs.
Time frame: From Baseline up to Day 23
Standard 12-lead ECGs were performed after the participant had rested quietly for at least 5 minutes in a supine position using an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, QTcF, and QRS complex. Clinical significance was determined based on investigator's discretion. Baseline of ECG parameters was defined as average of the triplicate ECGs collected at each time point before dosing on Day 1 within each period.
Time frame: From Baseline up to Day 23
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured with the participant in a supine position after at least 5 minutes of rest. Vital signs were categorized as 1) supine diastolic blood pressure (DBP) minimum (min) less than (<)50 and maximum (max) increase greater than or equal to (>=) 20 millimeter of mercury (mmHg); 2) supine systolic blood pressure (SBP) max. decrease >=20 and min. <90 (mmHg).
Time frame: From Baseline up to Day 23
The clinical laboratory tests include hematology, chemistry, urinalysis and other tests. Following parameters were analyzed for laboratory assessments: Hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); Chemistry: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Albumin, Alkaline Phosphatase, Total Bilirubin, Creatinine, Uric Acid, Sodium, Potassium; Glucose(Fasting), Urea, Chloride, Bicarbonates, Total protein; Urinalysis: (decimal logarithm of reciprocal of hydrogen ion activity )[pH], Glucose, Protein, Blood, Ketones, Nitrites, Leukocyte esterase; Others tests: Pregnancy test, Urine drug screening, Covid-19 testing. Clinically significant laboratory abnormality findings were based on investigator discretion.
Time frame: Baseline, 3, 4 and 5 hours post-dose on Day 3
Change from baseline in QTcF intervals were analyzed using a MMRM model with sequence, period, treatment, time (post-dose timepoint) and treatment by time interaction as fixed effect, participants within sequence as a random effect and baseline QTcF as a covariate. A compound symmetry covariance matrix was fitted to the repeated times within participant and the Kenward-Roger approximation was used for estimating degrees of freedom.
Pfizer
Industry
A Phase 1, Randomized, Double-blind, Sponsor-Open, Placebo- and Positive-Controlled Crossover Study to Investigate the Effect of Multiple Doses of Sisunatovir on QTc Interval in Healthy Adult 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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