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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Unnamed facility
Miami, Florida, United States
Pharmacokinetic Assessment of ROS, ATO and Digoxin alone and in the presence of CVC, as measured by maximum plasma concentration (Cmax)
Time frame: Days 1 and 13
Pharmacokinetic Assessment of SIM alone and in the presence of CVC, as measured by maximum plasma concentration (Cmax)
Time frame: Days 1 and 12
Pharmacokinetic Assessment of Caffeine alone and in the presence of CVC, as measured by maximum plasma concentration (Cmax)
Time frame: 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)
Time frame: 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)
Time frame: Days 1 and 13
Pharmacokinetic Assessment of SIM alone and in the presence of CVC, as measured by minimum plasma concentration (Cmin)
Time frame: 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)
Time frame: Days 1 and 12
Pharmacokinetic Assessment of Caffeine alone and in the presence of CVC, as measured by minimum plasma concentration (Cmin)
Time frame: 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)
Time frame: Days 1 and 13
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Evaluation of Adverse Events
Evaluate adverse events
Time frame: 23 days
Changes from Baseline in Clinical Laboratory Tests
Evaluate changes from baseline in clinical laboratory tests including serum chemistry, and hematology
Time frame: Baseline and 23 days
Changes from Baseline in 12-lead ECGs
Evaluate changes from baseline in 12-lead ECGs
Time frame: Baseline and 23 days
Changes from Baseline in Vital Signs
Evaluate changes from baseline in vital signs, including blood pressure and pulse rate
Time frame: Baseline and 23 days
Changes from Baseline in Physical Examinations
Evaluate changes from baseline in physical examinations
Time frame: Baseline and 23 days