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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-524060-38-00 | EU Trial (CTIS) Number |
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The purpose of this study is to evaluate the disease-drug-drug interaction (DDDI) potential of afimkibart (also known as RO7790121). This will be assessed by the characterization of the pharmacokinetics (PK) of cytochrome P450 (CYP) enzyme substrates alone and after administration of afimkibart in participants with moderately to severely active ulcerative colitis (UC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Afimkibart Treatment and CYP Cocktail Group | Experimental | Participants will receive doses of a CYP cocktail and doses of afimkibart in the DDDI phase, followed by an optional long-term extension phase. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Afimkibart | Drug | Afimkibart will be administered as per the schedule defined in the protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-time Curve Up to Time t (AUC0-t [AUC last]) of CYP Probe Substrates (Midazolam, 1-OH-Midazolam, Omeprazole, 5-OH-Omeprazole, Dextromethorphan, Dextrorphan, R-Warfarin, S-Warfarin, Caffeine, and Paraxanthine) | Up to approximately 13 weeks | |
| Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUCinf) of CYP Probe Substrates (Midazolam, 1-OH-Midazolam, Omeprazole, 5-OH-Omeprazole, Dextromethorphan, Dextrorphan, R-Warfarin, S-Warfarin, Caffeine, and Paraxanthine) | Up to approximately 13 weeks | |
| Maximum Plasma Concentration (Cmax) of CYP Probe Substrates (Midazolam, 1-OH-Midazolam, Omeprazole, 5-OH-Omeprazole, Dextromethorphan, Dextrorphan, R-Warfarin, S-Warfarin, Caffeine, and Paraxanthine) | Up to approximately 13 weeks | |
| Time to Maximum Concentration (Tmax) of CYP Probe Substrates (Midazolam, 1-OH-Midazolam, Omeprazole, 5-OH-Omeprazole, Dextromethorphan, Dextrorphan, R-Warfarin, S-Warfarin, Caffeine, and Paraxanthine) | Up to approximately 13 weeks | |
| Elimination Half-life (T1/2) of CYP Probe Substrates (Midazolam, 1-OH-Midazolam, Omeprazole, 5-OH-Omeprazole, Dextromethorphan, Dextrorphan, R-Warfarin, S-Warfarin, Caffeine, and Paraxanthine) | Up to approximately 13 weeks | |
| Metabolite-to-parent Area Under the Curve From Time 0 (AUC0-t) Ratio for CYP Probe Substrates (Midazolam and 1-OH-Midazolam, Omeprazole and 5-OH-Omeprazole, Dextromethorphan and Dextrorphan, and Caffeine and Paraxanthine) | Up to approximately 13 weeks | |
| Metabolite-to-parent Area Under the Concentration-time Curve from Time 0 to Infinity (AUC0-inf) Ratio for CYP Probe Substrates (Midazolam and 1-OH-Midazolam, Omeprazole and 5-OH-Omeprazole, Dextromethorphan and Dextrorphan, and Caffeine and Paraxanthine) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Adverse Events (AEs) | Up to approximately 5 years | |
| Predose and Peak Serum Concentration of Afimkibart | Up to approximately 5 years |
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Inclusion Criteria:
UC Specific Inclusion Criteria:
Exclusion Criteria:
Inflammatory Bowel Disease (IBD) Exclusion Criteria:
Medical History Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number : GA46438 https://forpatients.roche.com/ | Contact | 888-662-6728 (U.S. Only) | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erick H. Alayo Medical Corporation - Gastro SB Clinic | Recruiting | Chula Vista | California | 91910 | United States | |
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| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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| Caffeine | Drug | Caffeine will be administered orally as part of a CYP cocktail per the schedule defined in the protocol. |
|
| Warfarin | Drug | Warfarin will be administered orally as part of a CYP cocktail per the schedule defined in the protocol. |
|
| Omeprazole | Drug | Omeprazole will be administered orally as part of a CYP cocktail per the schedule defined in the protocol. |
|
| Dextromethorphan | Drug | Dextromethorphan will be administered orally as part of a CYP cocktail per the schedule defined in the protocol. |
|
| Midazolam | Drug | Midazolam will be administered orally as part of a CYP cocktail per the schedule defined in the protocol. |
|
| Vitamin K | Other | Vitamin K will be administered orally as a rescue medication following warfarin administration per the schedule outlined in the protocol. |
|
| Up to approximately 13 weeks |
| Metabolite-to-parent Concentration of CYP Probe Substrates (Midazolam and 1-OH-Midazolam, Omeprazole and 5-OH-Omeprazole, Dextromethorphan and Dextrorphan, and Caffeine and Paraxanthine) | Up to approximately 13 weeks |
| Gastro Health Research |
| Recruiting |
| Miami |
| Florida |
| 33176-2416 |
| United States |
| Charite Research Organisation GmbH | Recruiting | Berlin | 10117 | Germany |
| Royal Liverpool University Hospital | Recruiting | Liverpool | L7 8XP | United Kingdom |
| University College London Hospitals | Recruiting | London | W1T 7HA | United Kingdom |
| Royal Victoria Infirmary | Recruiting | Newcastle upon Tyne | NE1 4LP | United Kingdom |
| ID | Term |
|---|---|
| D002110 | Caffeine |
| D014859 | Warfarin |
| D009853 | Omeprazole |
| D003915 | Dextromethorphan |
| D008874 | Midazolam |
| D014812 | Vitamin K |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D009285 | Naphthoquinones |
| D009281 | Naphthalenes |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010836 | Phytol |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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