Overview

This trial is active, not recruiting.

Condition healthy
Treatments cenicriviroc, omeprazole, famotidine
Phase phase 1
Sponsor Tobira Therapeutics, Inc.
Start date January 2016
End date June 2016
Trial size 48 participants
Trial identifier NCT02684799, 652-123

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Part 1 Group 1 (12 subjects) will receive CVC 150 mg on Days 1, 7 and 13.
cenicriviroc Cenicriviroc 150 mg
(Active Comparator)
Part 1 Group 1 (12 subjects) will receive Omeprazole 20 mg from Days 2-7, and Omeprazole 40 mg from Days 8-13.
omeprazole Omeprazole 20 mg
(Experimental)
Part 1 Group 2 (12 subjects) will receive CVC 150 mg on Days 1, 5, 9 and 13.
cenicriviroc Cenicriviroc 150 mg
(Active Comparator)
Part 1 Group 2 (12 subjects) will receive Famotidine 40 mg on Days 5, 9 and 13.
famotidine Famotidine 40 mg
(Experimental)
Part 2 (24 subjects) will receive Cenicriviroc from Days 1-10 and Days 11-20.
cenicriviroc Cenicriviroc 150 mg
(Active Comparator)
Part 2 (24 subjects) will receive Omeprazole from Days 11-20.
omeprazole Omeprazole 20 mg

Primary Outcomes

Measure
Pharmacokinetic Assessment of CVC, as measured by maximum plasma concentration (Cmax)
time frame: 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)
time frame: 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)
time frame: Days 1, 7, and 13 for Part 1 Group 1. Days 1, 5, 9, and 13 for Part 1 Group 2.

Secondary Outcomes

Measure
Evaluation of Adverse Events
time frame: 23 days
Changes from Baseline in Clinical Laboratory Tests
time frame: Baseline and 23 days
Changes from Baseline in 12-lead ECGs
time frame: Baseline and 23 days
Changes from Baseline in Vital Signs
time frame: Baseline and 23 days
Changes from Baseline in Physical Examinations
time frame: Baseline and 23 days

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

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.

Additional Information

Official title 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)
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Tobira Therapeutics, Inc..