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| ID | Type | Description | Link |
|---|---|---|---|
| C5241004 | Other Identifier | Alias Study Number | |
| 2018-003256-21 | EudraCT Number |
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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:
This study is looking for health adult participants that meet the following criteria:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Itraconazole | Drug | Itraconazole capsules |
| |
| Verapamil |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of RV521 on Cmax of Midazolam | The specified pharmacokinetic parameter will be summarised using descriptive statistics | Baseline to study day 17 |
| Effect of RV521 on tmax of Midazolam | The specified pharmacokinetic parameter will be summarised using descriptive statistics | Baseline to study day 17 |
| Effect of RV521 on t1/2 of Midazolam | The specified pharmacokinetic parameter will be summarised using descriptive statistics | Baseline to study day 17 |
| Effect of RV521 on AUC of Midazolam | The specified pharmacokinetic parameter will be summarised using descriptive statistics | Baseline to study day 17 |
| Effect of RV521 on CL/F of Midazolam | The specified pharmacokinetic parameter will be summarised using descriptive statistics | Baseline to study day 17 |
| Effect of itraconazole on Cmax of RV521 | The specified pharmacokinetic parameter will be summarised using descriptive statistics | Baseline to study day 12 |
| Effect of itraconazole on tmax of RV521 | The specified pharmacokinetic parameter will be summarised using descriptive statistics | Baseline to study day 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Screening to final study visit (performed at 7 days following the last dose of any intervention) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Richmond Pharmacology Ltd | London | SE1 1YR | United Kingdom |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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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| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| D014700 | Verapamil |
| D012293 | Rifampin |
| D008874 | Midazolam |
| C000717948 | sisunatovir |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 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 |
|
| Drug |
Verapamil tablets |
|
| Rifampicin | Drug | Rifampicin capsules |
|
|
| Midazolam | Drug | Midazolam oromucosal solution |
|
|
| Placebo for RV521 | Drug | Placebo for RV521 capsules |
|
| RV521 | Drug | RV521 capsules |
|
| Effect of itraconazole on t1/2 of RV521 |
The specified pharmacokinetic parameter will be summarised using descriptive statistics |
| Baseline to study day 12 |
| Effect of itraconazole on AUC of RV521 | The specified pharmacokinetic parameter will be summarised using descriptive statistics | Baseline to study day 12 |
| Effect of itraconazole on CL/F of RV521 | The specified pharmacokinetic parameter will be summarised using descriptive statistics | Baseline to study day 12 |
| Effect of verapamil on Cmax of RV521 | The specified pharmacokinetic parameter will be summarised using descriptive statistics | Baseline to study day 16 |
| Effect of verapamil on tmax of RV521 | The specified pharmacokinetic parameter will be summarised using descriptive statistics | Baseline to study day 16 |
| Effect of verapamil on t1/2 of RV521 | The specified pharmacokinetic parameter will be summarised using descriptive statistics | Baseline to study day 16 |
| Effect of verapamil on AUC of RV521 | The specified pharmacokinetic parameter will be summarised using descriptive statistics | Baseline to study day 16 |
| Effect of verapamil on CL/F of RV521 | The specified pharmacokinetic parameter will be summarised using descriptive statistics | Baseline to study day 16 |
| Effect of rifampicin on Cmax of RV521 | The specified pharmacokinetic parameter will be summarised using descriptive statistics | Baseline to study day 15 |
| Effect of rifampicin on tmax of RV521 | The specified pharmacokinetic parameter will be summarised using descriptive statistics | Baseline to study day 15 |
| Effect of rifampicin on t1/2 of RV521 | The specified pharmacokinetic parameter will be summarised using descriptive statistics | Baseline to study day 15 |
| Effect of rifampicin on AUC of RV521 | The specified pharmacokinetic parameter will be summarised using descriptive statistics | Baseline to study day 15 |
| Effect of rifampicin on CL/F of RV521 | The specified pharmacokinetic parameter will be summarised using descriptive statistics | Baseline to study day 15 |
| 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 |
| Baseline to to final study visit (performed at 7 days following the last dose of any intervention) |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D010879 |
| Piperazines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |