Miami, Florida, United States
NCT Number: NCT02685462
Pharmacokinetic and Safety Study of Cenicriviroc and HMG-CoA Reductase Inhibitors, Caffeine and Digoxin
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
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Notify MeKey information
Conditions
Age range
18 year–55 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Rosuvastatin
DrugOther names: Rosuvastatin 20 mg
atorvastatin
DrugOther names: Atorvastatin 20 mg
simvastatin
DrugOther names: Simvastatin 20 mg
Digoxin
DrugOther names: Digoxin 0.25 mg
Caffeine
DrugOther names: Caffine 200 mg
Primary outcomes
-
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
-
Evaluation of Adverse Events
Time frame: 23 days
Evaluate adverse events
-
Changes from Baseline in Clinical Laboratory Tests
Time frame: Baseline and 23 days
Evaluate changes from baseline in clinical laboratory tests including serum chemistry, and hematology
-
Changes from Baseline in 12-lead ECGs
Time frame: Baseline and 23 days
Evaluate changes from baseline in 12-lead ECGs
-
Changes from Baseline in Vital Signs
Time frame: Baseline and 23 days
Evaluate changes from baseline in vital signs, including blood pressure and pulse rate
-
Changes from Baseline in Physical Examinations
Time frame: Baseline and 23 days
Evaluate changes from baseline in physical examinations
Sponsors and collaborators
Lead sponsor
Tobira Therapeutics, Inc.
Industry
Registry information
Official study 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
Important dates
- Study start
- 2016
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Feb 18, 2016
- Registry last updated
- Nov 24, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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