Respiratory Syncytial Virus InfectionsPhase 1NCT03782662
A Study to Learn About the Drug-drug Interactions of Sisunatovir in Healthy Adult Participants
A Phase 1 study testing Itraconazole, Verapamil and Rifampicin in people with Respiratory Syncytial Virus Infections, run by Pfizer at 1 site in United Kingdom.
Trial summary
The purpose of this clinical trial is to learn about the interaction of sisunatovir with four medications (midazolam, itraconazole, rifampicin, and verapamil). These medications are known to have specific effects on enzymes and proteins that could influence drug absorption. 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?
- Itraconazole, Verapamil and Rifampicin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Nov 2018to 17 Mar 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
- Age 18 to 45 years, inclusive
- 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/m2
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)
- 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 Adaptive, Part Open-label, Part Randomised Phase 1 Clinical Trial in Healthy Volunteers to Study Drug Interactions With RV521 Including Those Mediated by CYP3A4 and P-glycoprotein
The purpose of this clinical trial is to learn about the interaction of sisunatovir with four medications (midazolam, itraconazole, rifampicin, and verapamil). These medications are known to have specific effects on enzymes and proteins that could influence drug absorption.
This study will be conducted in 4 Cohorts:
Read more
- Cohort 1 will receive midazolam and sisunatovir or placebo,
- Cohort 2 will receive Itraconazole and sisunatovir,
- Cohort 3 will receive verapamil and sisunatovir,
- Cohort 4 will receive rifampicin and sisunatovir. A placebo looks like sisunatovir but does not contain any active medicine in it.
This study is looking for health adult participants that meet the following criteria:
- Caucasians age 18 to 45 years
- All fertile participants must agree to the use of highly effective contraception
- Body mass index (BMI) of 18-25.0 kg/m2
- 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.
This study consists of 2 parts, Part A and Part B. Part A will enroll up to 104 participants. The design of Part B will be determined after the completion of Part A.
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- Itraconazole, Verapamil, Rifampicin, Midazolam, Placebo for 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.
ItraconazoleDrug
Itraconazole capsules
VerapamilDrug
Verapamil tablets
RifampicinDrug
Also called Rifadin
Rifampicin capsules
MidazolamDrug
Also called Midazolam Prefilled Syringe, Buccolam
Midazolam oromucosal solution
Placebo for RV521Drug
Placebo for RV521 capsules
RV521Drug
RV521 capsules
| Study group | Role | What they receive |
|---|---|---|
| RV521 plus Itraconazole | Experimental | RV521 drug substance in capsule for oral administration, a single 200 mg dose administered on D1 and a single 200 mg dose administered on D7 plus Itraconazole 100 mg capsules for oral administration, a 200 mg dose administered once daily on D4 - D10, inclusive Receives: Drug: Itraconazole; Drug: RV521 |
| RV521 plus Verapamil | Experimental | RV521 drug substance in capsule for oral administration, a single 200 mg dose administered on D1 and a single 200 mg dose administered on D11 plus Verapamil, 80 mg tablets for oral administration, an 80 mg dose administered TDS daily on D4 - D14, inclusive Receives: Drug: Verapamil; Drug: RV521 |
| RV521 plus Rifampicin | Experimental | RV521 drug substance in capsule for oral administration, a single 200 mg dose administered on D1 and a single 200 mg dose administered on D10 plus Rifadin, Rifampicin, 300 mg capsules for oral administration, a 600 mg dose administered once daily on D4 - D10, inclusive Receives: Drug: Rifampicin; Drug: RV521 |
| RV521 plus Midazolam | Experimental | RV521 drug substance in capsule for oral administration, 200 mg dose administered BID on D2 - D15, inclusive plus Buccolam 10 mg oromucosal solution of midazolam, oral syringes, a single 10 mg dose administered on D1 and a single 200 mg dose administered on D15 Receives: Drug: Midazolam; Drug: RV521 |
| Placebo plus Midazolam | Placebo comparator | Placebo for RV521 in capsule for oral administration, 200 mg dose administered BID on D2 - D15, inclusive plus Buccolam 10 mg oromucosal solution of midazolam, oral syringes, a single 10 mg dose administered on D1 and a single 200 mg dose administered on D15 Receives: Drug: Midazolam; Drug: Placebo for RV521 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of RV521 on Cmax of Midazolam
The specified pharmacokinetic parameter will be summarised using descriptive statistics
Measured: Baseline to study day 17
Effect of RV521 on tmax of Midazolam
The specified pharmacokinetic parameter will be summarised using descriptive statistics
Measured: Baseline to study day 17
Effect of RV521 on t1/2 of Midazolam
The specified pharmacokinetic parameter will be summarised using descriptive statistics
Measured: Baseline to study day 17
Effect of RV521 on AUC of Midazolam
The specified pharmacokinetic parameter will be summarised using descriptive statistics
Measured: Baseline to study day 17
Effect of RV521 on CL/F of Midazolam
The specified pharmacokinetic parameter will be summarised using descriptive statistics
Measured: Baseline to study day 17
Effect of itraconazole on Cmax of RV521
The specified pharmacokinetic parameter will be summarised using descriptive statistics
Measured: Baseline to study day 12
Effect of itraconazole on tmax of RV521
The specified pharmacokinetic parameter will be summarised using descriptive statistics
Measured: Baseline to study day 12
Effect of itraconazole on t1/2 of RV521
The specified pharmacokinetic parameter will be summarised using descriptive statistics
Measured: Baseline to study day 12
Effect of itraconazole on AUC of RV521
The specified pharmacokinetic parameter will be summarised using descriptive statistics
Measured: Baseline to study day 12
Effect of itraconazole on CL/F of RV521
The specified pharmacokinetic parameter will be summarised using descriptive statistics
Measured: Baseline to study day 12
Effect of verapamil on Cmax of RV521
The specified pharmacokinetic parameter will be summarised using descriptive statistics
Measured: Baseline to study day 16
Effect of verapamil on tmax of RV521
The specified pharmacokinetic parameter will be summarised using descriptive statistics
Measured: Baseline to study day 16
Effect of verapamil on t1/2 of RV521
The specified pharmacokinetic parameter will be summarised using descriptive statistics
Measured: Baseline to study day 16
Effect of verapamil on AUC of RV521
The specified pharmacokinetic parameter will be summarised using descriptive statistics
Measured: Baseline to study day 16
Effect of verapamil on CL/F of RV521
The specified pharmacokinetic parameter will be summarised using descriptive statistics
Measured: Baseline to study day 16
Effect of rifampicin on Cmax of RV521
The specified pharmacokinetic parameter will be summarised using descriptive statistics
Measured: Baseline to study day 15
Effect of rifampicin on tmax of RV521
The specified pharmacokinetic parameter will be summarised using descriptive statistics
Measured: Baseline to study day 15
Effect of rifampicin on t1/2 of RV521
The specified pharmacokinetic parameter will be summarised using descriptive statistics
Measured: Baseline to study day 15
Effect of rifampicin on AUC of RV521
The specified pharmacokinetic parameter will be summarised using descriptive statistics
Measured: Baseline to study day 15
Effect of rifampicin on CL/F of RV521
The specified pharmacokinetic parameter will be summarised using descriptive statistics
Measured: Baseline to study day 15
Secondary outcomes (2)
Number of subjects with treatment-related adverse events as assessed by NCI CTCAE V5.0
The number of subjects with treatment-related adverse events will be summarised by treatment group using descriptive statistics
Measured: Screening to final study visit (performed at 7 days following the last dose of any intervention)
Number of subjects with QT/QTc interval changes relative to baseline who received RV521 (monotherapy), Midazolam (monotherapy) or RV521 and Midazolam (combination therapy)
Descriptive statistics will be given by time point and dose-group for absolute values and change from baseline. Results will be tabulated and for QTc, the difference to time matched placebo will also be displayed
Measured: Baseline to 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 posted20 Dec 2018
- Study start7 Nov 2018
- Primary completion17 Mar 2019
- Study completion17 Mar 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 82 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
- NCT03782662
- Sponsor's protocol ID
- REVC004
- Other IDs
- C5241004, 2018-003256-21, 2018
- Status last verified
- Apr 2024
- First submitted
- 5 Dec 2018
- Last updated
- 22 Apr 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 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adaptive, Part Open-label, Part Randomised Phase 1 Clinical Trial in Healthy Volunteers to Study Drug Interactions With RV521 Including Those Mediated by CYP3A4 and P-glycoprotein
- ClinicalTrials.gov ID
- NCT03782662
- Acronym / sponsor ID
- REVC004
- Conditions
- Respiratory Syncytial Virus Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2018 (actual)
- Primary completion
- 17 Mar 2019 (actual)
- Study completion
- 17 Mar 2019 (actual)
- First posted
- 20 Dec 2018 (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 interaction of sisunatovir with four medications (midazolam, itraconazole, rifampicin, and verapamil). These medications are known to have specific effects on enzymes and proteins that could influence drug absorption.
This study will be conducted in 4 Cohorts:
- Cohort 1 will receive midazolam and sisunatovir or placebo,
- Cohort 2 will receive Itraconazole and sisunatovir,
- Cohort 3 will receive verapamil and sisunatovir,
- Cohort 4 will receive rifampicin and sisunatovir. A placebo looks like sisunatovir but does not contain any active medicine in it.
This study is looking for health adult participants that meet the following criteria:
- Caucasians age 18 to 45 years
- All fertile participants must agree to the use of highly effective contraception
- Body mass index (BMI) of 18-25.0 kg/m2
- 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.
This study consists of 2 parts, Part A and Part B. Part A will enroll up to 104 participants. The design of Part B will be determined after the completion of Part A.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| RV521 plus Itraconazole | Experimental | Drug: Itraconazole, Drug: RV521RV521 drug substance in capsule for oral administration, a single 200 mg dose administered on D1 and a single 200 mg dose administered on D7 plus Itraconazole 100 mg capsules for oral administration, a 200 mg dose administered once daily on D4 - D10, inclusive |
| RV521 plus Verapamil | Experimental | Drug: Verapamil, Drug: RV521RV521 drug substance in capsule for oral administration, a single 200 mg dose administered on D1 and a single 200 mg dose administered on D11 plus Verapamil, 80 mg tablets for oral administration, an 80 mg dose administered TDS daily on D4 - D14, inclusive |
| RV521 plus Rifampicin | Experimental | Drug: Rifampicin, Drug: RV521RV521 drug substance in capsule for oral administration, a single 200 mg dose administered on D1 and a single 200 mg dose administered on D10 plus Rifadin, Rifampicin, 300 mg capsules for oral administration, a 600 mg dose administered once daily on D4 - D10, inclusive |
| RV521 plus Midazolam | Experimental | Drug: Midazolam, Drug: RV521RV521 drug substance in capsule for oral administration, 200 mg dose administered BID on D2 - D15, inclusive plus Buccolam 10 mg oromucosal solution of midazolam, oral syringes, a single 10 mg dose administered on D1 and a single 200 mg dose administered on D15 |
| Placebo plus Midazolam | Placebo comparator | Drug: Midazolam, Drug: Placebo for RV521Placebo for RV521 in capsule for oral administration, 200 mg dose administered BID on D2 - D15, inclusive plus Buccolam 10 mg oromucosal solution of midazolam, oral syringes, a single 10 mg dose administered on D1 and a single 200 mg dose administered on D15 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18 to 45 years, inclusive
- 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/m2
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)
- 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 |
|---|---|---|
| ItraconazoleItraconazole capsules | Drug | RV521 plus Itraconazole |
| VerapamilVerapamil tablets | Drug | RV521 plus Verapamil |
| RifampicinAlso: RifadinRifampicin capsules | Drug | RV521 plus Rifampicin |
| MidazolamAlso: Midazolam Prefilled Syringe, BuccolamMidazolam oromucosal solution | Drug | Placebo plus Midazolam, RV521 plus Midazolam |
| Placebo for RV521Placebo for RV521 capsules | Drug | Placebo plus Midazolam |
| RV521RV521 capsules | Drug | RV521 plus Itraconazole, RV521 plus Midazolam, RV521 plus Rifampicin, RV521 plus Verapamil |
Primary outcome
Effect of RV521 on Cmax of Midazolam
Time frame: Baseline to study day 17
The specified pharmacokinetic parameter will be summarised using descriptive statistics
Effect of RV521 on tmax of Midazolam
Time frame: Baseline to study day 17
The specified pharmacokinetic parameter will be summarised using descriptive statistics
Effect of RV521 on t1/2 of Midazolam
Time frame: Baseline to study day 17
The specified pharmacokinetic parameter will be summarised using descriptive statistics
Effect of RV521 on AUC of Midazolam
Time frame: Baseline to study day 17
The specified pharmacokinetic parameter will be summarised using descriptive statistics
Effect of RV521 on CL/F of Midazolam
Time frame: Baseline to study day 17
The specified pharmacokinetic parameter will be summarised using descriptive statistics
Effect of itraconazole on Cmax of RV521
Time frame: Baseline to study day 12
The specified pharmacokinetic parameter will be summarised using descriptive statistics
Effect of itraconazole on tmax of RV521
Time frame: Baseline to study day 12
The specified pharmacokinetic parameter will be summarised using descriptive statistics
Effect of itraconazole on t1/2 of RV521
Time frame: Baseline to study day 12
The specified pharmacokinetic parameter will be summarised using descriptive statistics
Effect of itraconazole on AUC of RV521
Time frame: Baseline to study day 12
The specified pharmacokinetic parameter will be summarised using descriptive statistics
Effect of itraconazole on CL/F of RV521
Time frame: Baseline to study day 12
The specified pharmacokinetic parameter will be summarised using descriptive statistics
Effect of verapamil on Cmax of RV521
Time frame: Baseline to study day 16
The specified pharmacokinetic parameter will be summarised using descriptive statistics
Effect of verapamil on tmax of RV521
Time frame: Baseline to study day 16
The specified pharmacokinetic parameter will be summarised using descriptive statistics
Effect of verapamil on t1/2 of RV521
Time frame: Baseline to study day 16
The specified pharmacokinetic parameter will be summarised using descriptive statistics
Effect of verapamil on AUC of RV521
Time frame: Baseline to study day 16
The specified pharmacokinetic parameter will be summarised using descriptive statistics
Effect of verapamil on CL/F of RV521
Time frame: Baseline to study day 16
The specified pharmacokinetic parameter will be summarised using descriptive statistics
Effect of rifampicin on Cmax of RV521
Time frame: Baseline to study day 15
The specified pharmacokinetic parameter will be summarised using descriptive statistics
Effect of rifampicin on tmax of RV521
Time frame: Baseline to study day 15
The specified pharmacokinetic parameter will be summarised using descriptive statistics
Effect of rifampicin on t1/2 of RV521
Time frame: Baseline to study day 15
The specified pharmacokinetic parameter will be summarised using descriptive statistics
Effect of rifampicin on AUC of RV521
Time frame: Baseline to study day 15
The specified pharmacokinetic parameter will be summarised using descriptive statistics
Effect of rifampicin on CL/F of RV521
Time frame: Baseline to study day 15
The specified pharmacokinetic parameter will be summarised using descriptive statistics
2 secondary outcomes
Number of subjects with treatment-related adverse events as assessed by NCI CTCAE V5.0
Time frame: Screening to final study visit (performed at 7 days following the last dose of any intervention)
Number of subjects with QT/QTc interval changes relative to baseline who received RV521 (monotherapy), Midazolam (monotherapy) or RV521 and Midazolam (combination therapy)
Time frame: Baseline to 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 22 Apr 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 Itraconazole, Verapamil and Rifampicin 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 4 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 22 Apr 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. 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?
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?
Effect of RV521 on Cmax of Midazolam (time frame: Baseline to study day 17). The study lists 20 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 22 Apr 2024.