Clinical trial NCT02685462: Pharmacokinetic and Safety Study of Cenicriviroc and HMG-CoA Reductase Inhibitors, Caffeine and Digoxin
Official title: A Phase 1 Open-Label Study in Healthy Adult Subjects to Assess the Effect of Cenicriviroc Mesylate (CVC) on the Pharmacokinetics (PK) of HMG-CoA Reductase Inhibitors (Rosuvastatin, Atorvastatin and Simvastatin), Caffeine and Digoxin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Tobira Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2016-02-18
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 1, Open-Label, 3-Period, Single-sequence, Drug-drug Interaction Study in Healthy Subjects to Assess the Effect of Cenicriviroc on the Pharmacokinetics (PK) of HMG-CoA Reductase Inhibitors \[Rosuvastatin (ROS), Atorvastatin (ATO) and Simvastatin (SIM)\], Caffeine and Digoxin


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.
* Known or suspected hypersensitivity or allergic reaction to any of the components of CVC, ROS, ATO, SIM, Digoxin or Caffeine 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 ROS, ATO and Digoxin alone and in the presence of CVC, as measured by maximum plasma concentration (Cmax)
timeFrame: Days 1 and 13
measure: Pharmacokinetic Assessment of SIM alone and in the presence of CVC, as measured by maximum plasma concentration (Cmax)
timeFrame: Days 1 and 12
measure: Pharmacokinetic Assessment of Caffeine alone and in the presence of CVC, as measured by maximum plasma concentration (Cmax)
timeFrame: Days 1 and 13
measure: Pharmacokinetic Assessment of ROS, ATO and Digoxin alone and in the presence of CVC, as measured by minimum plasma concentration (Cmin)
timeFrame: Days 1 and 13
measure: Pharmacokinetic Assessment of ROS, ATO and Digoxin alone and in the presence of CVC, as measured by area under the plasma concentration-time curve (AUC)
timeFrame: Days 1 and 13
measure: Pharmacokinetic Assessment of SIM alone and in the presence of CVC, as measured by minimum plasma concentration (Cmin)
timeFrame: Days 1 and 12
measure: Pharmacokinetic Assessment of SIM alone and in the presence of CVC, as measured by area under the plasma concentration-time curve (AUC)
timeFrame: Days 1 and 12
measure: Pharmacokinetic Assessment of Caffeine alone and in the presence of CVC, as measured by minimum plasma concentration (Cmin)
timeFrame: Days 1 and 13
measure: Pharmacokinetic Assessment of Caffeine alone and in the presence of CVC, as measured by area under the plasma concentration-time curve (AUC)
timeFrame: Days 1 and 13
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
state: Florida
Study officials:
affiliation: Tobira Therapeutics, Inc.
name: Millie Gottwald, PharmD
role: STUDY_DIRECTOR
References: