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This is a Phase 1, Single and Multiple-Dose, Open-Label Study in Healthy Subjects to Assess the Effect of the Acid Reducing Agents, Omeprazole and Famotidine, on the PK of CVC
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 Group 1 (Cenicriviroc) | Experimental | Part 1 Group 1 (12 subjects) will receive CVC 150 mg on Days 1, 7 and 13. |
|
| Part 1 Group 1 (Omeprazole) | Active Comparator | Part 1 Group 1 (12 subjects) will receive Omeprazole 20 mg from Days 2-7, and Omeprazole 40 mg from Days 8-13. |
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| Part 1 Group 2 (Cenicriviroc) | Experimental | Part 1 Group 2 (12 subjects) will receive CVC 150 mg on Days 1, 5, 9 and 13. |
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| Part 1 Group 2 (Famotidine) | Active Comparator | Part 1 Group 2 (12 subjects) will receive Famotidine 40 mg on Days 5, 9 and 13. |
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| Part 2 (Cenicriviroc) | Experimental | Part 2 (24 subjects) will receive Cenicriviroc from Days 1-10 and Days 11-20. |
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| Part 2 (Omeprazole) | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cenicriviroc | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Assessment of CVC, as measured by maximum plasma concentration (Cmax) | Days 1, 7, and 13 for Part 1 Group 1. Days 1, 5, 9, and 13 for Part 1 Group 2. | |
| Pharmacokinetic Assessment of CVC, as measured by minimum plasma concentration (Cmin) | Days 1, 7, and 13 for Part 1 Group 1. Days 1, 5, 9, and 13 for Part 1 Group 2. | |
| Pharmacokinetic Assessment of CVC, as measured by area under the plasma concentration-time curve (AUC) | Days 1, 7, and 13 for Part 1 Group 1. Days 1, 5, 9, and 13 for Part 1 Group 2. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Adverse Events | Evaluate adverse events | 23 days |
| Changes from Baseline in Clinical Laboratory Tests | Evaluate changes from baseline in clinical laboratory tests including serum chemistry, hematology and urinalysis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Star Seyedkazemi, PharmD | Tobira Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SeaView Research, Inc. | Miami | Florida | 33126 | United States |
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| ID | Term |
|---|---|
| C506967 | cenicriviroc |
| D009853 | Omeprazole |
| D015738 | Famotidine |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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Part 2 (24 subjects) will receive Omeprazole from Days 11-20. |
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| Omeprazole | Drug |
|
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| Famotidine | Drug |
|
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| Baseline and 23 days |
| Changes from Baseline in 12-lead ECGs | Evaluate changes from baseline in 12-lead ECGs | Baseline and 23 days |
| Changes from Baseline in Vital Signs | Evaluate changes from baseline in vital signs, including blood pressure and pulse rate | Baseline and 23 days |
| Changes from Baseline in Physical Examinations | Evaluate changes from baseline in physical examinations | Baseline and 23 days |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013844 | Thiazoles |
| D001393 | Azoles |