Overview

This trial is active, not recruiting.

Condition healthy
Treatments rosuvastatin, atorvastatin, simvastatin, digoxin, caffeine
Phase phase 1
Sponsor Tobira Therapeutics, Inc.
Start date January 2016
End date June 2016
Trial size 36 participants
Trial identifier NCT02685462, 652-124

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification pharmacokinetics study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Group 1 (12 subjects) will receive Rosuvastatin on Days 1 and 13.
rosuvastatin Rosuvastatin 20 mg
(Active Comparator)
Group 1 (12 subjects) will receive Digoxin on Days 1 and 13.
digoxin Digoxin 0.25 mg
(Active Comparator)
Group 1 (12 subjects) will receive Caffeine on Days 1 and 13.
caffeine Caffine 200 mg
(Active Comparator)
Group 2 (12 subjects) will receive Atorvastatin on Days 1 and 13.
atorvastatin Atorvastatin 20 mg
(Experimental)
Subjects in Group 1 and Group 2 will receive Cenicriviroc on Days 3-12. Subjects in Group 3 will receive Cenicriviroc on Days 2-12.
rosuvastatin Rosuvastatin 20 mg
atorvastatin Atorvastatin 20 mg
simvastatin Simvastatin 20 mg
digoxin Digoxin 0.25 mg
caffeine Caffine 200 mg
(Active Comparator)
Group 3 (12 subjects) will receive Simvastatin on Days 1 and 12.
simvastatin Simvastatin 20 mg

Primary Outcomes

Measure
Pharmacokinetic Assessment of ROS, ATO and Digoxin alone and in the presence of CVC, as measured by maximum plasma concentration (Cmax)
time frame: Days 1 and 13
Pharmacokinetic Assessment of SIM alone and in the presence of CVC, as measured by maximum plasma concentration (Cmax)
time frame: Days 1 and 12
Pharmacokinetic Assessment of Caffeine alone and in the presence of CVC, as measured by maximum plasma concentration (Cmax)
time frame: Days 1 and 13
Pharmacokinetic Assessment of ROS, ATO and Digoxin alone and in the presence of CVC, as measured by minimum plasma concentration (Cmin)
time frame: Days 1 and 13
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)
time frame: Days 1 and 13
Pharmacokinetic Assessment of SIM alone and in the presence of CVC, as measured by minimum plasma concentration (Cmin)
time frame: Days 1 and 12
Pharmacokinetic Assessment of SIM alone and in the presence of CVC, as measured by area under the plasma concentration-time curve (AUC)
time frame: Days 1 and 12
Pharmacokinetic Assessment of Caffeine alone and in the presence of CVC, as measured by minimum plasma concentration (Cmin)
time frame: Days 1 and 13
Pharmacokinetic Assessment of Caffeine alone and in the presence of CVC, as measured by area under the plasma concentration-time curve (AUC)
time frame: Days 1 and 13

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. - 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.

Additional Information

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