Back to resultsA Study to Learn About Effect of Sisunatovir in Healthy Adult Male Participants
Primary Purpose
Respiratory Syncytial Virus Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
200 mg RV521/78 µCi [ 14C]-RV521.
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Syncytial Virus Infections
Eligibility Criteria
Inclusion Criteria (key): Males Age 18- 55 years Body mass index (BMI) 18.0 kg/m2 to 32.0 kg/m2 Body weight 55.0 kg to 100.0 kg Considered to be in good health Nonsmoker Content of 14C in urine, whole blood, and/or plasma samples does not exceed the general environmental background level of 14C Exclusion Criteria (key): Clinically significant abnormal medical history or any abnormal finding on physical examination, vital signs, ECG, laboratory tests History of cancer that has not been in full remission for >5 years Acute illness within 14 days prior to Day 1 History of significant drug allergies History or presence of alcohol or drug abuse Recent history of incomplete bladder emptying with voiding or awakening more than once at night to void Usual habit of <1 or >3 bowel movements per day Exposure to radiation for therapeutic, diagnostic, or occupational reasons within the 12 months prior to Day 1. Participation in another clinical study in which a [14C]-labeled drug was administered within 1 year prior to Check-in Administration of another investigational medication within 60 days (or 5 half-lives, whichever is longer) prior to Day 1 Participation in an investigational-device study within 60 days prior to Day 1 Any ECG abnormality considered to be clinically significant by the Investigator QTcF interval >450 msec and QRS interval >120 msec Family history of long QT syndrome or of unexplained sudden death in a first-degree relative under 50 years of age Documented congenital or acquired long QT syndrome Presence of clinically significant hypertension Presence of clinically significant hypotension Loss or donation of more than 500 mL blood within 60 days prior to the Screening Excessive consumption of alcohol Use of any live vaccinations within 30 days Use/consumption of food or drugs known to be moderate or strong cytochrome P450 3A4 (CYP3A4) inducers or potent CYP3A4 inhibitors within 14 days or 5 half-lives, whichever is longer, prior to RV521 administration
Sites / Locations
- Pharmaron Clinical Pharmacology Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
200 mg RV521/78 µCi [ 14C]-RV521
Arm Description
200 mg RV521/78 µCi [ 14C]-RV521
Outcomes
Primary Outcome Measures
Tmax (Time of maximum observed concentration)
PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects
Cmax (Maximum observed concentration)
PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects
AUC0-inf (Area under the concentration-time curve (AUC) extrapolated to infinity)
PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects
AUC0-last (AUC from the time of dosing to the time of the last measurable concentration)
PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects
lambdaz (Rate constant associated with the terminal elimination phase)
PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects
t1/2 (half-life of the terminal elimination phase)
PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects
CL/F (Apparent clearance of the drug from plasma after oral administration)
PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects
Vz/F (Volume of distribution associated with the terminal phase)
PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects
CLR (renal clearance)
PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects
Fe (fraction of administered drug excreted into urine)
PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects
Ae0-t (cumulative amount of 14C excreted into urine from time 0 to the last sampling interval)
PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects
Ae0-t (Cumulative amount of 14C excreted into urine and feces from time 0 to the last sampling interval (in units of mass-equivalents/g))
Mass balance parameters in urinary and fecal excretion of radioactivity
Aet (Amount of 14C excreted into urine and feces per sampling interval (in units of mass-equivalents/g))
Mass balance parameters in urinary and fecal excretion of radioactivity
Fet (Fraction of 14C excreted into urine and feces per sampling interval (in units of %))
Mass balance parameters in urinary and fecal excretion of radioactivity
Fe0-t (Cumulative fraction of 14C excreted into urine or feces from time 0)
Mass balance parameters in urinary and fecal excretion of radioactivity
14C associated with % of AUC of the total in plasma
Metabolite Profiling and Identification
14C associated with % of administered dose of the total in urine and feces
Metabolite Profiling and Identification
Secondary Outcome Measures
Spontaneously reported adverse events (AEs) during the Treatment Period
safety and tolerability of a single oral dose of RV521 in healthy male subjects
Spontaneously reported serious AEs (SAEs) during the Treatment Period
Safety and tolerability of a single oral dose of RV521 in healthy male subjects
Use of concomitant medications
Safety and tolerability of a single oral dose of RV521 in healthy male subjects
Unscheduled assessments as needed for management of AEs
Safety and tolerability of a single oral dose of RV521 in healthy male subjects
Clinically significant changes from baseline of any of the following: Vital Signs (blood pressure, heart rate [HR], respiratory rate [RR], and oral temperature)
Safety and tolerability of a single oral dose of RV521 in healthy male subjects
Clinically significant changes from baseline of any of the following: 12-lead electrocardiogram (ECD) assessments
Safety and tolerability of a single oral dose of RV521 in healthy male subjects
Clinically significant changes from baseline of any of the following: Physical examinations
Safety and tolerability of a single oral dose of RV521 in healthy male subjects
Blood/Plasma AUC Ratio
AUC0-inf of total 14C in whole blood divided by the AUC0-inf of total 14C in plasma
Amount of 14C excreted into nostrils per sampling interval (in units of mass-equivalents/g)
Metabolite Profiling and Identification
Cumulative amount of 14C excreted into nostrils, urine, and feces from time 0 to the last sampling interval (in units of mass-equivalents/g)
Metabolite Profiling and Identification
Evaluation of total radioactivity in nasal samples following a single oral administration of [ 14C]-RV521 to healthy male subjects
PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects
Structural identification of major metabolites
Identification of each metabolite that accounts for ≥10% of circulating radiolabel
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05873764
Brief Title
A Study to Learn About Effect of Sisunatovir in Healthy Adult Male Participants
Official Title
[14C] -RV521.HCl - A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion Following a Single Oral Dose in Healthy Male Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 25, 2022 (Actual)
Primary Completion Date
July 12, 2022 (Actual)
Study Completion Date
July 12, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this clinical trial is to learn about the safety, effects, and tolerability of the study medicine (sisunatovir).
This study is looking for healthy adult participants who meet the following criteria:
Males age 18 to 55 years
All fertile participants must agree to the use of highly effective contraception
Body mass index (BMI) of 18 to 32.0 kg/m2; body weight of 55.0 to 100.0 kg.
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.
This study will enroll up to 10 participants. All study participants will receive 1 dose of sisunatovir by mouth. The study duration is expected to be about 9 weeks. This includes a 28-day screening period, 16-day inpatient stay, and 2 overnight follow-up visits, if needed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
200 mg RV521/78 µCi [ 14C]-RV521
Arm Type
Experimental
Arm Description
200 mg RV521/78 µCi [ 14C]-RV521
Intervention Type
Drug
Intervention Name(s)
200 mg RV521/78 µCi [ 14C]-RV521.
Intervention Description
200 mg RV521/78 µCi [ 14C]-RV521
Primary Outcome Measure Information:
Title
Tmax (Time of maximum observed concentration)
Description
PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects
Time Frame
Day 1 (time 0) to Day 29
Title
Cmax (Maximum observed concentration)
Description
PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects
Time Frame
Day 1 (time 0) to Day 29
Title
AUC0-inf (Area under the concentration-time curve (AUC) extrapolated to infinity)
Description
PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects
Time Frame
Day 1 (time 0) to Day 29
Title
AUC0-last (AUC from the time of dosing to the time of the last measurable concentration)
Description
PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects
Time Frame
Day 1 (time 0) to Day 29
Title
lambdaz (Rate constant associated with the terminal elimination phase)
Description
PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects
Time Frame
Day 1 (time 0) to Day 29
Title
t1/2 (half-life of the terminal elimination phase)
Description
PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects
Time Frame
Day 1 (time 0) to Day 29
Title
CL/F (Apparent clearance of the drug from plasma after oral administration)
Description
PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects
Time Frame
Day 1 (time 0) to Day 29
Title
Vz/F (Volume of distribution associated with the terminal phase)
Description
PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects
Time Frame
Day 1 (time 0) to Day 29
Title
CLR (renal clearance)
Description
PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects
Time Frame
Day 1 (time 0) to Day 29
Title
Fe (fraction of administered drug excreted into urine)
Description
PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects
Time Frame
Day 1 (time 0) to Day 29
Title
Ae0-t (cumulative amount of 14C excreted into urine from time 0 to the last sampling interval)
Description
PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects
Time Frame
Day 1 (time 0) to Day 29
Title
Ae0-t (Cumulative amount of 14C excreted into urine and feces from time 0 to the last sampling interval (in units of mass-equivalents/g))
Description
Mass balance parameters in urinary and fecal excretion of radioactivity
Time Frame
Day 1 (time 0) to Day 29
Title
Aet (Amount of 14C excreted into urine and feces per sampling interval (in units of mass-equivalents/g))
Description
Mass balance parameters in urinary and fecal excretion of radioactivity
Time Frame
Day 1 (time 0) to Day 29
Title
Fet (Fraction of 14C excreted into urine and feces per sampling interval (in units of %))
Description
Mass balance parameters in urinary and fecal excretion of radioactivity
Time Frame
Day 1 (time 0) to Day 29
Title
Fe0-t (Cumulative fraction of 14C excreted into urine or feces from time 0)
Description
Mass balance parameters in urinary and fecal excretion of radioactivity
Time Frame
Day 1 (time 0) to Day 29
Title
14C associated with % of AUC of the total in plasma
Description
Metabolite Profiling and Identification
Time Frame
Day 1 (time 0) to Day 29
Title
14C associated with % of administered dose of the total in urine and feces
Description
Metabolite Profiling and Identification
Time Frame
Day 1 (time 0) to Day 29
Secondary Outcome Measure Information:
Title
Spontaneously reported adverse events (AEs) during the Treatment Period
Description
safety and tolerability of a single oral dose of RV521 in healthy male subjects
Time Frame
Day -1 to Day 29
Title
Spontaneously reported serious AEs (SAEs) during the Treatment Period
Description
Safety and tolerability of a single oral dose of RV521 in healthy male subjects
Time Frame
Day -1 to Day 29
Title
Use of concomitant medications
Description
Safety and tolerability of a single oral dose of RV521 in healthy male subjects
Time Frame
Day -1 to Day 29
Title
Unscheduled assessments as needed for management of AEs
Description
Safety and tolerability of a single oral dose of RV521 in healthy male subjects
Time Frame
Day -1 to Day 29
Title
Clinically significant changes from baseline of any of the following: Vital Signs (blood pressure, heart rate [HR], respiratory rate [RR], and oral temperature)
Description
Safety and tolerability of a single oral dose of RV521 in healthy male subjects
Time Frame
Day -1 to Day 29
Title
Clinically significant changes from baseline of any of the following: 12-lead electrocardiogram (ECD) assessments
Description
Safety and tolerability of a single oral dose of RV521 in healthy male subjects
Time Frame
Day -1 to Day 29
Title
Clinically significant changes from baseline of any of the following: Physical examinations
Description
Safety and tolerability of a single oral dose of RV521 in healthy male subjects
Time Frame
Day -1 to Day 29
Title
Blood/Plasma AUC Ratio
Description
AUC0-inf of total 14C in whole blood divided by the AUC0-inf of total 14C in plasma
Time Frame
Day 1 (time 0 to Day 29)
Title
Amount of 14C excreted into nostrils per sampling interval (in units of mass-equivalents/g)
Description
Metabolite Profiling and Identification
Time Frame
Day 1 (time 0) to Day 29
Title
Cumulative amount of 14C excreted into nostrils, urine, and feces from time 0 to the last sampling interval (in units of mass-equivalents/g)
Description
Metabolite Profiling and Identification
Time Frame
Day 1 (time 0 to Day 29)
Title
Evaluation of total radioactivity in nasal samples following a single oral administration of [ 14C]-RV521 to healthy male subjects
Description
PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects
Time Frame
Day 1 (time 0) to Day 29
Title
Structural identification of major metabolites
Description
Identification of each metabolite that accounts for ≥10% of circulating radiolabel
Time Frame
Day 1 (time 0) to Day 29
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria (key):
Males
Age 18- 55 years
Body mass index (BMI) 18.0 kg/m2 to 32.0 kg/m2
Body weight 55.0 kg to 100.0 kg
Considered to be in good health
Nonsmoker
Content of 14C in urine, whole blood, and/or plasma samples does not exceed the general environmental background level of 14C
Exclusion Criteria (key):
Clinically significant abnormal medical history or any abnormal finding on physical examination, vital signs, ECG, laboratory tests
History of cancer that has not been in full remission for >5 years
Acute illness within 14 days prior to Day 1
History of significant drug allergies
History or presence of alcohol or drug abuse
Recent history of incomplete bladder emptying with voiding or awakening more than once at night to void
Usual habit of <1 or >3 bowel movements per day
Exposure to radiation for therapeutic, diagnostic, or occupational reasons within the 12 months prior to Day 1.
Participation in another clinical study in which a [14C]-labeled drug was administered within 1 year prior to Check-in
Administration of another investigational medication within 60 days (or 5 half-lives, whichever is longer) prior to Day 1
Participation in an investigational-device study within 60 days prior to Day 1
Any ECG abnormality considered to be clinically significant by the Investigator
QTcF interval >450 msec and QRS interval >120 msec
Family history of long QT syndrome or of unexplained sudden death in a first-degree relative under 50 years of age
Documented congenital or acquired long QT syndrome
Presence of clinically significant hypertension
Presence of clinically significant hypotension
Loss or donation of more than 500 mL blood within 60 days prior to the Screening
Excessive consumption of alcohol
Use of any live vaccinations within 30 days
Use/consumption of food or drugs known to be moderate or strong cytochrome P450 3A4 (CYP3A4) inducers or potent CYP3A4 inhibitors within 14 days or 5 half-lives, whichever is longer, prior to RV521 administration
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pharmaron Clinical Pharmacology Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=REVC008
Description
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Learn more about this trial
A Study to Learn About Effect of Sisunatovir in Healthy Adult Male Participants
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