HealthyPhase 1NCT05878522
A Study to Investigate the Effects of Sisunatovir on QTc Interval in Healthy Adult Participants.
A Phase 1 study testing sisunatovir and moxifloxacin in people with Healthy, run by Pfizer at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- sisunatovir and moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2023to 30 Oct 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body Mass Index (BMI) of 17.5 to 32 kg/m2, inclusive, and a total body weight >50 kg (110 lb).
- Capable of giving signed informed consent.
- At screening, no clinically relevant abnormalities identified by a detailed medical history, complete physical examination, including blood pressure (BP) and pulse rate measurement, standard 12-lead electrocardiogram (ECG) and clinical laboratory tests.
- --Exclusion criteria for all participants:
- Any condition or surgery possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection)
- Those with increased risk if dosed with moxifloxacin
Show all 17Show fewer
- Self-reported history or risk factors for QT prolongation or torsades de pointes, congenital deafness, family history of cardiac arrest or suggest death, and family history of long QT syndrome
- Positive human immunodeficiency virus (HIV) antibodies
- Positive drug or alcohol test
- Screening supine 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-estimated glomerular filtration rate (GFR) <60 mL/min/1.73m2 at screening
- Standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, QTcF >450 ms, complete LBBB, signs of an acute or indeterminate- age myocardial infarction, ST-T interval changes suggestive of myocardial ischemia, second- or third- degree 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 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. Participants with an average QTc interval >450 milliseconds (ms) will not be allowed to participate in the study. Computer-interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding a participant.
- GFR <60 mL/min/1.73m2 based on CKD-EPI equation
- AST or ALT level ≥1.5 x upper limit normal (ULN)
- Gamma-GT> 1.2 x ULN
- Alkaline phosphatase > 1.2 x ULN
- Total bilirubin level ≥1.5 × 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
- History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1 ounce (30 mL) of 40% spirit, or 3 ounces (90 mL) of wine).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
New Haven Clinical Research Unit
New Haven, Connecticut, 06511
About this study
Official title: 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
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:
Read more
- 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.
- Conditions
- Healthy
- Being tested
- sisunatovir, placebo, moxifloxacin
- Keywords
- Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sisunatovirDrug
Also called PF-07923568
6 capsules administered Q12 hours for 5 doses
placeboDrug
6 capsules administered Q12 hours for 5 doses
moxifloxacinDrug
6 capsules of placebo administered Q12 hours for 4 doses, followed by a single tablet of moxifloxacin
sisunatovirDrug
Also called PF-07923568
7 capsules administered Q12 hours for 5 doses
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | 6 capsules of sisunatovir administered Q12 hours for 5 doses Receives: Drug: sisunatovir |
| Treatment B | Placebo comparator | 6 capsules of placebo administered Q12 hours for 5 doses Receives: Drug: placebo |
| Treatment C | Active comparator | 6 capsules of placebo administered Q12 hours for 4 doses, followed by a single tablet of moxifloxacin Receives: Drug: moxifloxacin |
| Treatment D | Experimental | 7 capsules of sisunatovir administered Q12 hours for 5 doses Receives: Drug: sisunatovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placebo-Adjusted Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) at Expected Maximum Concentration (Cmax) on Day 3 for Sisunatovir
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.
Measured: Baseline, Day 3
Secondary outcomes (5)
Number of Participants With Treatment Emergent Adverse Events
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.
Measured: From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Number of Participants With Clinically Significant Changes in Electrocardiogram Parameters
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.
Measured: From Baseline up to Day 23
Number of Participants Meeting Pre-defined Criteria for Vital Signs
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).
Measured: From Baseline up to Day 23
Number of Participants With Clinically Significant Changes in Laboratory Abnormalities
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.
Measured: From Baseline up to Day 23
Change From Baseline in QTcF of Moxifloxacin and Placebo at 3, 4 and 5 Hours Post-Dose of 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.
Measured: Baseline, 3, 4 and 5 hours post-dose on Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start15 May 2023
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single Group, Crossover study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05878522
- Sponsor's protocol ID
- C5241015
- Status last verified
- Oct 2024
- First submitted
- 9 May 2023
- Last updated
- 6 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05878522
- Acronym / sponsor ID
- C5241015
- Conditions
- Healthy
- Keywords
- Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 15 May 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 26 May 2023 (actual)
- Results
- Posted 6 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- Single Group, Crossover study
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: sisunatovir6 capsules of sisunatovir administered Q12 hours for 5 doses |
| Treatment B | Placebo comparator | Drug: placebo6 capsules of placebo administered Q12 hours for 5 doses |
| Treatment C | Active comparator | Drug: moxifloxacin6 capsules of placebo administered Q12 hours for 4 doses, followed by a single tablet of moxifloxacin |
| Treatment D | Experimental | Drug: sisunatovir7 capsules of sisunatovir administered Q12 hours for 5 doses |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Body Mass Index (BMI) of 17.5 to 32 kg/m2, inclusive, and a total body weight >50 kg (110 lb).
- Capable of giving signed informed consent.
- At screening, no clinically relevant abnormalities identified by a detailed medical history, complete physical examination, including blood pressure (BP) and pulse rate measurement, standard 12-lead electrocardiogram (ECG) and clinical laboratory tests.
- Any condition or surgery possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection)
- Those with increased risk if dosed with moxifloxacin
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sisunatovirAlso: PF-079235686 capsules administered Q12 hours for 5 doses | Drug | Treatment A |
| placebo6 capsules administered Q12 hours for 5 doses | Drug | Treatment B |
| moxifloxacin6 capsules of placebo administered Q12 hours for 4 doses, followed by a single tablet of moxifloxacin | Drug | Treatment C |
| sisunatovirAlso: PF-079235687 capsules administered Q12 hours for 5 doses | Drug | Treatment D |
Primary outcome
Placebo-Adjusted Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) at Expected Maximum Concentration (Cmax) on Day 3 for Sisunatovir
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.
5 secondary outcomes
Number of Participants With Treatment Emergent Adverse Events
Time frame: From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Number of Participants With Clinically Significant Changes in Electrocardiogram Parameters
Time frame: From Baseline up to Day 23
Number of Participants Meeting Pre-defined Criteria for Vital Signs
Time frame: From Baseline up to Day 23
Number of Participants With Clinically Significant Changes in Laboratory Abnormalities
Time frame: From Baseline up to Day 23
Change From Baseline in QTcF of Moxifloxacin and Placebo at 3, 4 and 5 Hours Post-Dose of Day 3
Time frame: Baseline, 3, 4 and 5 hours post-dose on Day 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing sisunatovir and moxifloxacin in people with Healthy, run by Pfizer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Placebo-Adjusted Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) at Expected Maximum Concentration (Cmax) on Day 3 for Sisunatovir (time frame: Baseline, Day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.