Healthy
Conditions
Brief summary
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
Interventions
Sponsors
Tobira Therapeutics, Inc.
Study design
Allocation
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. * 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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes from Baseline in Vital Signs | Baseline and 23 days | Evaluate changes from baseline in vital signs, including blood pressure and pulse rate |
| Evaluation of Adverse Events | 23 days | Evaluate adverse events |
| Changes from Baseline in Physical Examinations | Baseline and 23 days | Evaluate changes from baseline in physical examinations |
| Changes from Baseline in Clinical Laboratory Tests | Baseline and 23 days | Evaluate changes from baseline in clinical laboratory tests including serum chemistry, hematology and urinalysis |
| Changes from Baseline in 12-lead ECGs | Baseline and 23 days | Evaluate changes from baseline in 12-lead ECGs |
Countries
United States
Outcome results
None listed