Clinical trial NCT02684799: Pharmacokinetic and Safety Study of Cenicriviroc and Acid Reducing Agents When Dosed Alone or in Combination
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Tobira Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2016-02-18
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Pharmacokinetic Assessment of CVC, as measured by maximum plasma concentration (Cmax)
timeFrame: Days 1, 7, and 13 for Part 1 Group 1. Days 1, 5, 9, and 13 for Part 1 Group 2.
measure: Pharmacokinetic Assessment of CVC, as measured by minimum plasma concentration (Cmin)
timeFrame: Days 1, 7, and 13 for Part 1 Group 1. Days 1, 5, 9, and 13 for Part 1 Group 2.
measure: Pharmacokinetic Assessment of CVC, as measured by area under the plasma concentration-time curve (AUC)
timeFrame: 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
timeFrame: 23 days
measure: Changes from Baseline in Clinical Laboratory Tests
timeFrame: Baseline and 23 days
measure: Changes from Baseline in 12-lead ECGs
timeFrame: Baseline and 23 days
measure: Changes from Baseline in Vital Signs
timeFrame: Baseline and 23 days
measure: Changes from Baseline in Physical Examinations
timeFrame: Baseline and 23 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: SeaView Research, Inc.
state: Florida
Study officials:
affiliation: Tobira Therapeutics, Inc.
name: Star Seyedkazemi, PharmD
role: STUDY_DIRECTOR
References: