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

Completed · Phase 1

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT02684799

Run by

Tobira Therapeutics, Inc.

People needed

48

Starts

2016-01-31

Expected to finish

2016-04-11

Last updated by the study team

2017-11-24

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• SeaView Research, Inc. — Miami, Florida, United States

Full record on ClinicalTrials.gov

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