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| ID | Type | Description | Link |
|---|---|---|---|
| 1007296 | Other Identifier | IRAS |
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The purpose of this study is to confirm there is no significant effect of gastric pH changes of famotidine on the drug levels of afimetoran in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Afimetoran, followed by famotidine + afimetoran | Experimental |
| |
| Famotidine + afimetoran, followed by afimetoran | Experimental |
| |
| Afimetoran | Experimental |
| |
| Famotidine, followed by afimetoran | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Famotidine | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Up to 20 Days | |
| Time to attain maximum observed plasma concentration (Tmax) | Up to 20 Days | |
| Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T]) | Up to 20 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Up to 52 Days | |
| Number of participants with clinical laboratory abnormalities | Up to 52 Days | |
| Number of participants with vital sign abnormalities |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Nottingham | Nottinghamshire | NG11 6JS | United Kingdom |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
See Plan Description
See Plan Description
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| ID | Term |
|---|---|
| D015738 | Famotidine |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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|
| Afimetoran | Drug | Specified dose on specified days |
|
|
| Up to 52 Days |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to 52 Days |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |