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Pharmacokinetic and Safety Study of Cenicriviroc and HMG-CoA Reductase Inhibitors, Caffeine and Digoxin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02685462
Recruitment Status : Completed
First Posted : February 18, 2016
Last Update Posted : November 24, 2017
Sponsor:
Information provided by (Responsible Party):
Tobira Therapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Rosuvastatin Drug: Atorvastatin Drug: Simvastatin Drug: Digoxin Drug: Caffeine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 31, 2016
Actual Primary Completion Date : February 23, 2016
Actual Study Completion Date : February 23, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Digoxin

Arm Intervention/treatment
Active Comparator: Group 1 (Rosuvastatin)
Group 1 (12 subjects) will receive Rosuvastatin on Days 1 and 13.
Drug: Rosuvastatin
Other Name: Rosuvastatin 20 mg

Active Comparator: Group 1 (Digoxin)
Group 1 (12 subjects) will receive Digoxin on Days 1 and 13.
Drug: Digoxin
Other Name: Digoxin 0.25 mg

Active Comparator: Group 1 (Caffeine)
Group 1 (12 subjects) will receive Caffeine on Days 1 and 13.
Drug: Caffeine
Other Name: Caffine 200 mg

Active Comparator: Group 2 (Atorvastatin)
Group 2 (12 subjects) will receive Atorvastatin on Days 1 and 13.
Drug: Atorvastatin
Other Name: Atorvastatin 20 mg

Experimental: Cenicriviroc

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.

Drug: Rosuvastatin
Other Name: Rosuvastatin 20 mg

Drug: Atorvastatin
Other Name: Atorvastatin 20 mg

Drug: Simvastatin
Other Name: Simvastatin 20 mg

Drug: Digoxin
Other Name: Digoxin 0.25 mg

Drug: Caffeine
Other Name: Caffine 200 mg

Active Comparator: Group 3 (Simvastatin)
Group 3 (12 subjects) will receive Simvastatin on Days 1 and 12.
Drug: Simvastatin
Other Name: Simvastatin 20 mg




Primary Outcome Measures :
  1. 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 ]
  2. Pharmacokinetic Assessment of SIM alone and in the presence of CVC, as measured by maximum plasma concentration (Cmax) [ Time Frame: Days 1 and 12 ]
  3. Pharmacokinetic Assessment of Caffeine alone and in the presence of CVC, as measured by maximum plasma concentration (Cmax) [ Time Frame: Days 1 and 13 ]
  4. 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 ]
  5. 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 ]
  6. Pharmacokinetic Assessment of SIM alone and in the presence of CVC, as measured by minimum plasma concentration (Cmin) [ Time Frame: Days 1 and 12 ]
  7. 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 ]
  8. Pharmacokinetic Assessment of Caffeine alone and in the presence of CVC, as measured by minimum plasma concentration (Cmin) [ Time Frame: Days 1 and 13 ]
  9. 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 Outcome Measures :
  1. Evaluation of Adverse Events [ Time Frame: 23 days ]
    Evaluate adverse events

  2. 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

  3. Changes from Baseline in 12-lead ECGs [ Time Frame: Baseline and 23 days ]
    Evaluate changes from baseline in 12-lead ECGs

  4. 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

  5. Changes from Baseline in Physical Examinations [ Time Frame: Baseline and 23 days ]
    Evaluate changes from baseline in physical examinations



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02685462


Locations
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United States, Florida
Miami, Florida, United States
Sponsors and Collaborators
Tobira Therapeutics, Inc.
Investigators
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Study Director: Millie Gottwald, PharmD Tobira Therapeutics, Inc.

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Responsible Party: Tobira Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02685462    
Other Study ID Numbers: 652-124
First Posted: February 18, 2016    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017
Additional relevant MeSH terms:
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TAK-652
Digoxin
Caffeine
Atorvastatin
Rosuvastatin Calcium
Simvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Anti-Arrhythmia Agents
Cardiotonic Agents
Protective Agents
CCR5 Receptor Antagonists
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents