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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-507116-12-00 | Registry Identifier | CTIS (EU) |
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The purpose of this study is to see how rabeprazole affects the level of the study medicine sisunatovir in the blood of healthy adult participants. Rabeprazole is a medicine that reduces the amount of acid the stomach makes.
The information from this study may inform how sisunatovir will be used in the future with medicines that reduce stomach acid.
This study is seeking healthy participants who:
The study will look at the blood levels of sisunatovir with and without taking rabeprazole. This will help see how sisunatovir should be given in the future.
The total planned time of participation is about 10 to 11 weeks. The study consists of:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Part 1: Sisunatovir without rabeprazole |
|
| Treatment B | Active Comparator | Part 1: Sisunatovir with 40 mg rabeprazole |
|
| Treatment C | Active Comparator | Part 2: Sisunatovir suspension without rabeprazole |
|
| Treatment D | Experimental | Part 2: Sisunatovir suspension with 20 mg rabeprazole |
|
| Treatment E | Experimental | Part 2: Sisunatovir suspension with 40 mg rabeprazole |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sisunatovir | Drug | Single Dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | 0 to 72 hour postdose | |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) | AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf). | 0 to 72 hours postdose |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) | 0 to 72 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) | Baseline up to 35 days after last dose of study intervention | |
| Number of Participants With Clinical Laboratory Abnormalities | Baseline to Study Day 12 (Part 1) or Study Day 20 (Part 2) |
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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 |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit - Brussels | Brussels | Bruxelles-capitale, Région de | B-1070 | Belgium |
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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 |
|---|---|
| C000717948 | sisunatovir |
| D064750 | Rabeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Rabeprazole 40 mg |
| Drug |
Tablets once daily for 7 days |
|
| Sisunatovir suspension | Drug | Tablets once daily for 7 days |
|
| Rabeprazole 20 mg | Drug | Tablets once daily for 7 days |
|
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Baseline to Study Day 12 (Part 1) or Study Day 20 (Part 2) |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |