Pharmacokinetic and Safety Study of Cenicriviroc and HMG-CoA Reductase Inhibitors, Caffeine and Digoxin
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group 1 (Rosuvastatin) Group 1 (12 subjects) will receive Rosuvastatin on Days 1 and 13. |
Drug: Rosuvastatin
Other Names:
|
| Active Comparator: Group 1 (Digoxin) Group 1 (12 subjects) will receive Digoxin on Days 1 and 13. |
Drug: Digoxin
Other Names:
|
| Active Comparator: Group 1 (Caffeine) Group 1 (12 subjects) will receive Caffeine on Days 1 and 13. |
Drug: Caffeine
Other Names:
|
| Active Comparator: Group 2 (Atorvastatin) Group 2 (12 subjects) will receive Atorvastatin on Days 1 and 13. |
Drug: Atorvastatin
Other Names:
|
| Experimental: Cenicriviroc 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. |
Drug: Rosuvastatin
Other Names:
Drug: Atorvastatin
Other Names:
Drug: Simvastatin
Other Names:
Drug: Digoxin
Other Names:
Drug: Caffeine
Other Names:
|
| Active Comparator: Group 3 (Simvastatin) Group 3 (12 subjects) will receive Simvastatin on Days 1 and 12. |
Drug: Simvastatin
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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) [Days 1 and 13]
Secondary Outcome Measures
- Evaluation of Adverse Events [23 days]
Evaluate adverse events
- Changes from Baseline in Clinical Laboratory Tests [Baseline and 23 days]
Evaluate changes from baseline in clinical laboratory tests including serum chemistry, and hematology
- Changes from Baseline in 12-lead ECGs [Baseline and 23 days]
Evaluate changes from baseline in 12-lead ECGs
- Changes from Baseline in Vital Signs [Baseline and 23 days]
Evaluate changes from baseline in vital signs, including blood pressure and pulse rate
- Changes from Baseline in Physical Examinations [Baseline and 23 days]
Evaluate changes from baseline in physical examinations
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Be informed of the nature of the study and have provided written informed voluntary consent.
-
Have a BMI ≥ 18.0 and ≤ 35.0 kg/m2.
-
Be in good general health with no clinically relevant abnormalities based on medical history, physical examination, clinical laboratory evaluations (clinical chemistry, hematology, urinalysis), and 12-lead ECG that, in the opinion of the Investigator, would affect subject safety.
-
Be able to communicate effectively with the Investigator and other study center personnel and agree to comply with the study procedures and restrictions.
Exclusion Criteria:
-
Any disease or condition that might affect drug absorption, metabolism, or excretion, or clinically significant cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, gastrointestinal, immunological, dermatological, neurological, or psychiatric disease, as determined by the Investigator and, if necessary, the Sponsor's Medical Monitor.
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History of stomach or intestinal surgery, except for fully healed appendectomy and/or cholecystectomy which will be allowed.
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Clinically significant illness or clinically significant surgery within 4 weeks before the administration of study medication.
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History of GERD, heartburn, or nausea more than once a month, or any similar symptoms requiring the regular use of antacids, or any use of H2 histamine blockers or proton-pump inhibitors over the past 3 months.
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History of achlorhydria, pernicious anemia, or peptic ulcers over the past 6 months.
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Known or suspected hypersensitivity or allergic reaction to any of the components of CVC, ROS, ATO, SIM, Digoxin or Caffeine tablets.
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History of malignancy, with the exception of cured basal cell or squamous cell carcinoma of the skin.
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If female, is pregnant or breast feeding, or has a positive pregnancy test result prior to the first dose of study medication.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Miami | Florida | United States |
Sponsors and Collaborators
- Tobira Therapeutics, Inc.
Investigators
- Study Director: Millie Gottwald, PharmD, Tobira Therapeutics, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 652-124