Respiratory Syncytial Virus InfectionsPhase 1NCT05873764
A Study to Learn About Effect of Sisunatovir in Healthy Adult Male Participants
A Phase 1 study testing 200 mg RV521/78 µCi [ 14C]-RV521. in people with Respiratory Syncytial Virus Infections, run by Pfizer at 1 site in United States.
Trial 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: 1. Males age 18 to 55 years 2. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- 200 mg RV521/78 µCi [ 14C]-RV521.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2022to 12 Jul 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Pharmaron Clinical Pharmacology Center
Baltimore, Maryland, 21201
About this study
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
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:
Read more
- 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.
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- 200 mg RV521/78 µCi [ 14C]-RV521.
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
200 mg RV521/78 µCi [ 14C]-RV521.Drug
200 mg RV521/78 µCi [ 14C]-RV521
| Study group | Role | What they receive |
|---|---|---|
| 200 mg RV521/78 µCi [ 14C]-RV521 | Experimental | 200 mg RV521/78 µCi [ 14C]-RV521 Receives: Drug: 200 mg RV521/78 µCi [ 14C]-RV521. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1 (time 0) to Day 29
Cmax (Maximum observed concentration)
PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects
Measured: Day 1 (time 0) to Day 29
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
Measured: Day 1 (time 0) to Day 29
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
Measured: Day 1 (time 0) to Day 29
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
Measured: Day 1 (time 0) to Day 29
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
Measured: Day 1 (time 0) to Day 29
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
Measured: Day 1 (time 0) to Day 29
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
Measured: Day 1 (time 0) to Day 29
CLR (renal clearance)
PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects
Measured: Day 1 (time 0) to Day 29
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
Measured: Day 1 (time 0) to Day 29
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
Measured: Day 1 (time 0) to Day 29
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
Measured: Day 1 (time 0) to Day 29
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
Measured: Day 1 (time 0) to Day 29
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
Measured: Day 1 (time 0) to Day 29
Fe0-t (Cumulative fraction of 14C excreted into urine or feces from time 0)
Mass balance parameters in urinary and fecal excretion of radioactivity
Measured: Day 1 (time 0) to Day 29
14C associated with % of AUC of the total in plasma
Metabolite Profiling and Identification
Measured: Day 1 (time 0) to Day 29
14C associated with % of administered dose of the total in urine and feces
Metabolite Profiling and Identification
Measured: Day 1 (time 0) to Day 29
Secondary outcomes (12)
Spontaneously reported adverse events (AEs) during the Treatment Period
safety and tolerability of a single oral dose of RV521 in healthy male subjects
Measured: Day -1 to Day 29
Spontaneously reported serious AEs (SAEs) during the Treatment Period
Safety and tolerability of a single oral dose of RV521 in healthy male subjects
Measured: Day -1 to Day 29
Use of concomitant medications
Safety and tolerability of a single oral dose of RV521 in healthy male subjects
Measured: Day -1 to Day 29
Unscheduled assessments as needed for management of AEs
Safety and tolerability of a single oral dose of RV521 in healthy male subjects
Measured: Day -1 to Day 29
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
Measured: Day -1 to Day 29
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
Measured: Day -1 to Day 29
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
Measured: Day -1 to Day 29
Blood/Plasma AUC Ratio
AUC0-inf of total 14C in whole blood divided by the AUC0-inf of total 14C in plasma
Measured: Day 1 (time 0 to Day 29)
Amount of 14C excreted into nostrils per sampling interval (in units of mass-equivalents/g)
Metabolite Profiling and Identification
Measured: Day 1 (time 0) to Day 29
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
Measured: Day 1 (time 0 to Day 29)
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
Measured: Day 1 (time 0) to Day 29
Structural identification of major metabolites
Identification of each metabolite that accounts for ≥10% of circulating radiolabel
Measured: Day 1 (time 0) to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start25 May 2022
- Primary completion12 Jul 2022
- Study completion12 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus InfectionsStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 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
- NCT05873764
- Sponsor's protocol ID
- REVC008
- Other IDs
- C5241008
- Status last verified
- May 2024
- First submitted
- 15 May 2023
- Last updated
- 16 May 2024
- Results posted
- No
- 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 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05873764
- Acronym / sponsor ID
- REVC008
- Conditions
- Respiratory Syncytial Virus Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 25 May 2022 (actual)
- Primary completion
- 12 Jul 2022 (actual)
- Study completion
- 12 Jul 2022 (actual)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 200 mg RV521/78 µCi [ 14C]-RV521 | Experimental | Drug: 200 mg RV521/78 µCi [ 14C]-RV521.200 mg RV521/78 µCi [ 14C]-RV521 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (21 listed)
- 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
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 |
|---|---|---|
| 200 mg RV521/78 µCi [ 14C]-RV521.200 mg RV521/78 µCi [ 14C]-RV521 | Drug | 200 mg RV521/78 µCi [ 14C]-RV521 |
Primary outcome
Tmax (Time of maximum observed concentration)
Time frame: Day 1 (time 0) to Day 29
PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects
Cmax (Maximum observed concentration)
Time frame: Day 1 (time 0) to Day 29
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)
Time frame: Day 1 (time 0) to Day 29
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)
Time frame: Day 1 (time 0) to Day 29
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)
Time frame: Day 1 (time 0) to Day 29
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)
Time frame: Day 1 (time 0) to Day 29
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)
Time frame: Day 1 (time 0) to Day 29
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)
Time frame: Day 1 (time 0) to Day 29
PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects
CLR (renal clearance)
Time frame: Day 1 (time 0) to Day 29
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)
Time frame: Day 1 (time 0) to Day 29
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)
Time frame: Day 1 (time 0) to Day 29
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))
Time frame: Day 1 (time 0) to Day 29
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))
Time frame: Day 1 (time 0) to Day 29
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 %))
Time frame: Day 1 (time 0) to Day 29
Mass balance parameters in urinary and fecal excretion of radioactivity
Fe0-t (Cumulative fraction of 14C excreted into urine or feces from time 0)
Time frame: Day 1 (time 0) to Day 29
Mass balance parameters in urinary and fecal excretion of radioactivity
14C associated with % of AUC of the total in plasma
Time frame: Day 1 (time 0) to Day 29
Metabolite Profiling and Identification
14C associated with % of administered dose of the total in urine and feces
Time frame: Day 1 (time 0) to Day 29
Metabolite Profiling and Identification
12 secondary outcomes
Spontaneously reported adverse events (AEs) during the Treatment Period
Time frame: Day -1 to Day 29
Spontaneously reported serious AEs (SAEs) during the Treatment Period
Time frame: Day -1 to Day 29
Use of concomitant medications
Time frame: Day -1 to Day 29
Unscheduled assessments as needed for management of AEs
Time frame: Day -1 to Day 29
Clinically significant changes from baseline of any of the following: Vital Signs (blood pressure, heart rate [HR], respiratory rate [RR], and oral temperature)
Time frame: Day -1 to Day 29
Clinically significant changes from baseline of any of the following: 12-lead electrocardiogram (ECD) assessments
Time frame: Day -1 to Day 29
Clinically significant changes from baseline of any of the following: Physical examinations
Time frame: Day -1 to Day 29
Blood/Plasma AUC Ratio
Time frame: Day 1 (time 0 to Day 29)
Amount of 14C excreted into nostrils per sampling interval (in units of mass-equivalents/g)
Time frame: Day 1 (time 0) to Day 29
Cumulative amount of 14C excreted into nostrils, urine, and feces from time 0 to the last sampling interval (in units of mass-equivalents/g)
Time frame: Day 1 (time 0 to Day 29)
Evaluation of total radioactivity in nasal samples following a single oral administration of [ 14C]-RV521 to healthy male subjects
Time frame: Day 1 (time 0) to Day 29
Structural identification of major metabolites
Time frame: Day 1 (time 0) to Day 29
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- 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 200 mg RV521/78 µCi [ 14C]-RV521. in people with Respiratory Syncytial Virus Infections, 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 7 inclusion and 21 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 16 May 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Tmax (Time of maximum observed concentration) (time frame: Day 1 (time 0) to Day 29). The study lists 17 primary outcomes in all. 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 16 May 2024.