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This is a Phase 1, Open-Label, 3-Period, Single-sequence, Drug-drug Interaction Study in Healthy Subjects to Assess the Effect of Cenicriviroc on the Pharmacokinetics (PK) of HMG-CoA Reductase Inhibitors [Rosuvastatin (ROS), Atorvastatin (ATO) and Simvastatin (SIM)], Caffeine and Digoxin
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (Rosuvastatin) | Active Comparator | Group 1 (12 subjects) will receive Rosuvastatin on Days 1 and 13. |
|
| Group 1 (Digoxin) | Active Comparator | Group 1 (12 subjects) will receive Digoxin on Days 1 and 13. |
|
| Group 1 (Caffeine) | Active Comparator | Group 1 (12 subjects) will receive Caffeine on Days 1 and 13. |
|
| Group 2 (Atorvastatin) | Active Comparator | Group 2 (12 subjects) will receive Atorvastatin on Days 1 and 13. |
|
| Cenicriviroc | Experimental | Subjects in Group 1 and Group 2 will receive Cenicriviroc on Days 3-12. Subjects in Group 3 will receive Cenicriviroc on Days 2-12. |
|
| Group 3 (Simvastatin) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Assessment of ROS, ATO and Digoxin alone and in the presence of CVC, as measured by maximum plasma concentration (Cmax) | Days 1 and 13 | |
| Pharmacokinetic Assessment of SIM alone and in the presence of CVC, as measured by maximum plasma concentration (Cmax) | Days 1 and 12 | |
| Pharmacokinetic Assessment of Caffeine alone and in the presence of CVC, as measured by maximum plasma concentration (Cmax) | Days 1 and 13 | |
| Pharmacokinetic Assessment of ROS, ATO and Digoxin alone and in the presence of CVC, as measured by minimum plasma concentration (Cmin) | Days 1 and 13 | |
| Pharmacokinetic Assessment of ROS, ATO and Digoxin alone and in the presence of CVC, as measured by area under the plasma concentration-time curve (AUC) | Days 1 and 13 | |
| Pharmacokinetic Assessment of SIM alone and in the presence of CVC, as measured by minimum plasma concentration (Cmin) | Days 1 and 12 | |
| Pharmacokinetic Assessment of SIM alone and in the presence of CVC, as measured by area under the plasma concentration-time curve (AUC) | Days 1 and 12 | |
| Pharmacokinetic Assessment of Caffeine alone and in the presence of CVC, as measured by minimum plasma concentration (Cmin) | Days 1 and 13 | |
| Pharmacokinetic Assessment of Caffeine alone and in the presence of CVC, as measured by area under the plasma concentration-time curve (AUC) |
| 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, and hematology |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Millie Gottwald, PharmD | Tobira Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami | Florida | United States |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| D000069059 | Atorvastatin |
| D019821 | Simvastatin |
| D004077 | Digoxin |
| D002110 | Caffeine |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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Group 3 (12 subjects) will receive Simvastatin on Days 1 and 12. |
|
| Atorvastatin |
| Drug |
|
|
| Simvastatin | Drug |
|
|
| Digoxin | Drug |
|
|
| Caffeine | Drug |
|
|
| Days 1 and 13 |
| 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 |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |