Pharmacokinetic and Safety Study of Cenicriviroc and Acid Reducing Agents When Dosed Alone or in Combination

Study Overview
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Brief Summary
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This is a Phase 1, Single and Multiple-Dose, Open-Label Study in Healthy Subjects to Assess the Effect of the Acid Reducing Agents, Omeprazole and Famotidine, on the PK of CVC

Official Title
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A Phase 1, Single and Multiple-Dose, Open-Label Study in Healthy Subjects to Assess the Effect of the Acid Reducing Agents, Omeprazole (OME) and Famotidine (FAM), on the Pharmacokinetics (PK) of Cenicriviroc Mesylate (CVC)

Conditions
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Healthy

Intervention / Treatment
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* Drug: Cenicriviroc
* Drug: Omeprazole
* Drug: Famotidine


Participation Criteria
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Eligibility Criteria
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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. Have a positive Helicobacter pylori urea breath test. Known or suspected hypersensitivity or allergic reaction to any of the components of CVC, OME or FAM 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1 Group 1 (Cenicriviroc)<br>Part 1 Group 1 (12 subjects) will receive CVC 150 mg on Days 1, 7 and 13. | Drug: Cenicriviroc<br> <br> * Other names: Cenicriviroc 150 mg;|
| Active Comparator: Part 1 Group 1 (Omeprazole)<br>Part 1 Group 1 (12 subjects) will receive Omeprazole 20 mg from Days 2-7, and Omeprazole 40 mg from Days 8-13. | Drug: Omeprazole<br> <br> * Other names: Omeprazole 40 mg;|
| Experimental: Part 1 Group 2 (Cenicriviroc)<br>Part 1 Group 2 (12 subjects) will receive CVC 150 mg on Days 1, 5, 9 and 13. | Drug: Cenicriviroc<br> <br> * Other names: Cenicriviroc 150 mg;|
| Active Comparator: Part 1 Group 2 (Famotidine)<br>Part 1 Group 2 (12 subjects) will receive Famotidine 40 mg on Days 5, 9 and 13. | Drug: Famotidine<br> <br> * Other names: Famotidine 40 mg;|
| Experimental: Part 2 (Cenicriviroc)<br>Part 2 (24 subjects) will receive Cenicriviroc from Days 1-10 and Days 11-20. | Drug: Cenicriviroc<br> <br> * Other names: Cenicriviroc 150 mg;|
| Active Comparator: Part 2 (Omeprazole)<br>Part 2 (24 subjects) will receive Omeprazole from Days 11-20. | Drug: Omeprazole<br> <br> * Other names: Omeprazole 40 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic Assessment of CVC, as measured by maximum plasma concentration (Cmax) |  | Days 1, 7, and 13 for Part 1 Group 1. Days 1, 5, 9, and 13 for Part 1 Group 2. | 
| Pharmacokinetic Assessment of CVC, as measured by minimum plasma concentration (Cmin) |  | Days 1, 7, and 13 for Part 1 Group 1. Days 1, 5, 9, and 13 for Part 1 Group 2. | 
| Pharmacokinetic Assessment of CVC, as measured by area under the plasma concentration-time curve (AUC) |  | Days 1, 7, and 13 for Part 1 Group 1. Days 1, 5, 9, and 13 for Part 1 Group 2. | 

Secondary Outcome Measures

| Outcome Measure | 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, hematology and urinalysis | 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 |