Respiratory Syncytial Virus InfectionsPhase 1C19007NCT04065698
Pharmacokinetics and Safety of RV521 Formulations
A Phase 1 study testing RV521 in people with Respiratory Syncytial Virus Infections, run by Pfizer at 1 site in United Kingdom.
Trial summary
The main aims of the study are to assess the pharmacokinetics and safety of single doses of RV521 administered as two different formulations Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- RV521
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Aug 2019to 9 Sep 2019
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing to comply with protocol defined contraception requirements
- In good health with no history of major medical conditions
- A body mass index (BMI) of 18-25 kg/m^2, inclusive
Who cannot join
- Evidence of any clinically significant or currently active major medical condition
- Positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening
- Not willing to comply with protocol defined restrictions for intake of drugs of abuse, alcohol, nicotine-containing products, medication (prescription, OTC, herbal, vitamins/minerals etc) and specified food and drink products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single Dose, Three Sequence Study in Healthy Adult Volunteers to Evaluate the Pharmacokinetics, Safety and Tolerability of RV521 Administered as the Drug in Capsule Formulation in the Fed State and the Dry Powder Blend Formulation Dispersed in Water in the Fed and Fasted States
The main aims of the study are to assess the pharmacokinetics and safety of single doses of RV521 administered as two different formulations
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- 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.
RV521Drug
Also called Sisunatovir
Single doses of RV521 administered as the drug in capsule formulation when fed and as the dry powder blend formulation dispersed in water when fed and whilst fasting, each on a separate dosing day.
| Study group | Role | What they receive |
|---|---|---|
| RV521 | Experimental | Three single 200 mg oral doses of RV521 administered on Day 1, Day 5 and Day 9 as either the drug in capsule (1 dosing occasion) or the dry powder blend dispersed in water (2 dosing occasions) Receives: Drug: RV521 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to maximum plasma concentration (tmax) for RV521
Measured: Baseline to study day 11
Terminal half life (t1/2) for RV521
Measured: Baseline to study day 11
Maximum observed plasma concentration (Cmax) for RV521
Measured: Baseline to study day 11
Area under the plasma concentration-time curve from time zero to last detectable plasma concentration (AUC0-t) for RV521
Measured: Baseline to study day 11
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) for RV521
Measured: Baseline to study day 11
Secondary outcomes (5)
Incidence of treatment emergent adverse events as assessed by CTCAE V5.0
Measured: Screening to final study visit (performed at 7 days following the last dose of any intervention)
Proportion of subjects with clinically significant changes in laboratory safety tests (haematology, chemistry, coagulation and urinalysis)
Measured: Screening to final study visit (performed at 7 days following the last dose of any intervention)
Proportion of subjects with morphological and/or rhythm abnormalities on ECG
Measured: Screening to final study visit (performed at 7 days following the last dose of any intervention)
Proportion of subjects with clinically significant changes in ECG time intervals (PR, QRS, QT and QTc intervals)
Measured: Screening to final study visit (performed at 7 days following the last dose of any intervention)
Proportion of subjects with clinically significant changes in vital signs (systolic blood pressure, diastolic blood pressure and pulse rate)
Measured: Screening to final study visit (performed at 7 days following the last dose of any intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start13 Aug 2019
- Primary completion2 Sep 2019
- Study completion9 Sep 2019
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
- Other
- 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
- Lorch, MD, Principal investigator, Richmond Pharmacology Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04065698
- Sponsor's protocol ID
- REVC005
- Other IDs
- 2019-000976-40, 2019
- Acronym
- C19007
- Status last verified
- Jun 2024
- First submitted
- 20 Aug 2019
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single Dose, Three Sequence Study in Healthy Adult Volunteers to Evaluate the Pharmacokinetics, Safety and Tolerability of RV521 Administered as the Drug in Capsule Formulation in the Fed State and the Dry Powder Blend Formulation Dispersed in Water in the Fed and Fasted States
- ClinicalTrials.gov ID
- NCT04065698
- Acronym / sponsor ID
- C19007 / REVC005
- 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
- 13 Aug 2019 (actual)
- Primary completion
- 2 Sep 2019 (actual)
- Study completion
- 9 Sep 2019 (actual)
- First posted
- 22 Aug 2019 (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 main aims of the study are to assess the pharmacokinetics and safety of single doses of RV521 administered as two different formulations
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RV521 | Experimental | Drug: RV521Three single 200 mg oral doses of RV521 administered on Day 1, Day 5 and Day 9 as either the drug in capsule (1 dosing occasion) or the dry powder blend dispersed in water (2 dosing occasions) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Willing to comply with protocol defined contraception requirements
- In good health with no history of major medical conditions
- A body mass index (BMI) of 18-25 kg/m^2, inclusive
Key exclusion criteria (3 listed)
- Evidence of any clinically significant or currently active major medical condition
- Positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening
- Not willing to comply with protocol defined restrictions for intake of drugs of abuse, alcohol, nicotine-containing products, medication (prescription, OTC, herbal, vitamins/minerals etc) and specified food and drink products
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 |
|---|---|---|
| RV521Also: SisunatovirSingle doses of RV521 administered as the drug in capsule formulation when fed and as the dry powder blend formulation dispersed in water when fed and whilst fasting, each on a separate dosing day. | Drug | RV521 |
Primary outcome
Time to maximum plasma concentration (tmax) for RV521
Time frame: Baseline to study day 11
Terminal half life (t1/2) for RV521
Time frame: Baseline to study day 11
Maximum observed plasma concentration (Cmax) for RV521
Time frame: Baseline to study day 11
Area under the plasma concentration-time curve from time zero to last detectable plasma concentration (AUC0-t) for RV521
Time frame: Baseline to study day 11
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) for RV521
Time frame: Baseline to study day 11
5 secondary outcomes
Incidence of treatment emergent adverse events as assessed by CTCAE V5.0
Time frame: Screening to final study visit (performed at 7 days following the last dose of any intervention)
Proportion of subjects with clinically significant changes in laboratory safety tests (haematology, chemistry, coagulation and urinalysis)
Time frame: Screening to final study visit (performed at 7 days following the last dose of any intervention)
Proportion of subjects with morphological and/or rhythm abnormalities on ECG
Time frame: Screening to final study visit (performed at 7 days following the last dose of any intervention)
Proportion of subjects with clinically significant changes in ECG time intervals (PR, QRS, QT and QTc intervals)
Time frame: Screening to final study visit (performed at 7 days following the last dose of any intervention)
Proportion of subjects with clinically significant changes in vital signs (systolic blood pressure, diastolic blood pressure and pulse rate)
Time frame: Screening to final study visit (performed at 7 days following the last dose of any intervention)
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 7 Jun 2024.
- 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.
Lorch, MD principal investigator
Richmond Pharmacology Limited
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 RV521 in people with Respiratory Syncytial Virus Infections, run by Pfizer at 1 site in United Kingdom.
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 3 inclusion and 3 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 7 Jun 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 Kingdom. 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?
Time to maximum plasma concentration (tmax) for RV521 (time frame: Baseline to study day 11). The study lists 5 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 7 Jun 2024; AzTrials last refreshed its copy on 7 Nov 2026.