Pharmacokinetic and Safety Study of Cenicriviroc and HMG-CoA Reductase Inhibitors, Caffeine and Digoxin



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:11/25/2017
Start Date:January 31, 2016
End Date:February 23, 2016

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A Phase 1 Open-Label Study in Healthy Adult Subjects to Assess the Effect of Cenicriviroc Mesylate (CVC) on the Pharmacokinetics (PK) of HMG-CoA Reductase Inhibitors (Rosuvastatin, Atorvastatin and Simvastatin), Caffeine and Digoxin

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


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.
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