Healthy
Conditions
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
Interventions
DRUGRosuvastatin
DRUGAtorvastatin
DRUGSimvastatin
DRUGDigoxin
DRUGCaffeine
Sponsors
Tobira Therapeutics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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. * History of stomach or intestinal surgery, except for fully healed appendectomy and/or cholecystectomy which will be allowed. * Clinically significant illness or clinically significant surgery within 4 weeks before the administration of study medication. * 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. * History of achlorhydria, pernicious anemia, or peptic ulcers over the past 6 months. * Known or suspected hypersensitivity or allergic reaction to any of the components of CVC, ROS, ATO, SIM, Digoxin or Caffeine tablets. * History of malignancy, with the exception of cured basal cell or squamous cell carcinoma of the skin. * If female, is pregnant or breast feeding, or has a positive pregnancy test result prior to the first dose of study medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Evaluation of Adverse Events | 23 days | Evaluate adverse events |
Countries
United States
Outcome results
None listed