A Study to Assess the Safety, Effects and Palatability of Sisunatovir in Healthy Adult Participants

NCT05712460 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: C52410062022-003426-53
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study is seeking healthy participants who are:

1. 1.Aged 18 to 65 years of age. All fertile participants must agree to use a highly effective method of contraception.
2. 2.Male and female participants who are overtly healthy as determined by medical evaluation. This includes medical history, physical examination, blood pressure, pulse rate, standard 12-lead ECG (electrocardiogram), and laboratory tests.
3. 3.BMI (body mass index) of 17.5 to 35 kg/m2; and a total body weight \>50 kg (110 lb).

Conditions

Respiratory Syncytial Viruses

Keywords

RSV; respiratory syncytial virus

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  An adverse event (AE) is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were any AEs that occurred following start of treatment.

  From start of treatment to 28-35 days after last dose (maximum upto 66 days)

• Number of Participants With Clinical Laboratory Abnormalities: Part 1

  Laboratory tests included haematology (Monocytes \[10\^9/L\] increase: \> 1.2\* upper limit of normal \[ULN\] and Monocytes/Leukocytes \[percentage\] {%}:\> 1.2\* ULN); clinical chemistry (serum) included Alanine Aminotransferase (units per liter \[U/L\]):\> 3.0\* ULN and Bicarbonate (milliequivalents per liter) (mEq/L): \>1.1\* ULN and in urinalysis (urine Hemoglobin (Scalar) more than equal to (\>=) 1, urine Bilirubin (Scalar) \>= 1, Hyaline Casts (/Low power field \[LPF\]) \>= 1. Number of participants with any clinical laboratory abnormalities is reported in this outcome.

  Up to Day 5

• Number of Participants With Newly Occurring Notable Abnormal Vital Signs: Part 1

  Supine blood pressure (BP) was measured with the participant's arm supported at the level of the heart and recorded after approximately 5 minutes of rest. Pulse rate was measured in the brachial/radial artery. Notable abnormal vital sign categories included: Systolic BP: \<90 millimeter of mercury \[mmHg\]; Systolic BP change from baseline: maximum increase and decrease \>=30 mmHg; Diastolic BP \<50 mmHg; Diastolic BP change from baseline: maximum decrease and increase ≥20 mmHg; pulse rate \<40 and \>120 beats per minute. Number of participants with newly occurring notable abnormal vital sign (i.e. change in supine systolic BP \>=30 millimeter of mercury \[mmHg\] increase) is reported in this outcome measure.

  Up to Day 5

• Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings: Part 1

  Standard 12-lead ECGs utilizing limb leads were used to measure PR interval, QT interval, QTc corrected using Fridericia's formula (QTcF), and QRS complex. ECG was performed after the participant had rested quietly for at least 5 minutes in a supine position. Clinical significance was determined by the investigator.

  Up to Day 7

Secondary Outcomes (24)

• Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Day 1: Part 1

  Pre-dose, 1, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day 1

• Dose Normalized AUCtau (AUCtau [dn]) for Day 1: Part 1

  Pre-dose, 1, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day 1

• Maximum Observed Plasma Concentration (Cmax) for Day 1: Part 1

  Pre-dose, 1, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day 1

• Dose Normalized Maximum Plasma Concentration (Cmax [dn]) for Day 1: Part 1

  Pre-dose, 1, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day 1

• Time to Reach Maximum Observed Plasma Concentration (Tmax) for Day 1: Part 1

  Pre-dose, 1, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day 1

Study Arms (5)

Group A: Higher dose sisunatovir

EXPERIMENTAL

higher dose of sisunatovir dosed every 12 hours

Drug: sisunatovir

Group B: Lower dose sisunatovir

EXPERIMENTAL

Lower dose of sisunatovir dosed every 12 hours

Drug: sisunatovir

Group C: Placebo

PLACEBO COMPARATOR

Placebo for sisunatovir dosed every 12 hours

Drug: Placebo

Group D: Higher dose of sisunatovir

EXPERIMENTAL

Higher dose of sisunatovir dosed every 12 hours under fasted conditions

Drug: sisunatovir

Group E: sisunatovir palatability

EXPERIMENTAL

Sisunatovir in 4 vehicles (water, saline, apple juice, infant formula) to assess the palatability of sisunatovir in each vehicle. sisunatovir will not be swallowed, participants will swirl and spit to assess various aspects of the taste.

Drug: sisunatovir

Interventions

sisunatovir DRUG

Sisunatovir is an orally administered RSV F-protein inhibitor being developed to target viral-host cell fusion for the treatment of adult and pediatric patients with RSV

Group A: Higher dose sisunatovir; Group B: Lower dose sisunatovir; Group D: Higher dose of sisunatovir; Group E: sisunatovir palatability

Placebo DRUG

Placebo for sisunatovir

Group C: Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants aged 18 to 65 years of age, inclusive, at the time of signing of the informed consent document (ICD).
• All fertile participants must agree to use a highly effective method of contraception.
• Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, including blood pressure, pulse rate, standard 12-lead electrocardiogram (ECG), and laboratory tests.
• Body mass index (BMI) of 17.5 to 35 kg/m2; and a total body weight \>50 kg (110 lb).

You may not qualify if:

• 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).
• Other 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 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.
• 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 the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation;
• Aspartate Aminotransferase (AST) or Alanine Transaminase (ALT) level ≥1.5 x upper limit of normal (ULN);
• Gamma-glutamyl transferase (Gamma-GT)\> ULN;
• Alkaline phosphatase \> 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit - Brussels

Brussels, Bruxelles-capitale, Région de, B-1070, Belgium

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

sisunatovir

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 3, 2023
• Study Start: February 8, 2023
• Primary Completion: April 28, 2023
• Study Completion: April 28, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)