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Pharmacokinetic and Safety Study of Cenicriviroc and Acid Reducing Agents When Dosed Alone or in Combination

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ClinicalTrials.gov Identifier: NCT02684799
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, 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

Condition or disease Intervention/treatment Phase
Healthy Drug: Cenicriviroc Drug: Omeprazole Drug: Famotidine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : January 31, 2016
Actual Primary Completion Date : April 11, 2016
Actual Study Completion Date : April 11, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part 1 Group 1 (Cenicriviroc)
Part 1 Group 1 (12 subjects) will receive CVC 150 mg on Days 1, 7 and 13.
Drug: Cenicriviroc
Other Name: Cenicriviroc 150 mg

Active Comparator: Part 1 Group 1 (Omeprazole)
Part 1 Group 1 (12 subjects) will receive Omeprazole 20 mg from Days 2-7, and Omeprazole 40 mg from Days 8-13.
Drug: Omeprazole
Other Names:
  • Omeprazole 20 mg
  • Omeprazole 40 mg

Experimental: Part 1 Group 2 (Cenicriviroc)
Part 1 Group 2 (12 subjects) will receive CVC 150 mg on Days 1, 5, 9 and 13.
Drug: Cenicriviroc
Other Name: Cenicriviroc 150 mg

Active Comparator: Part 1 Group 2 (Famotidine)
Part 1 Group 2 (12 subjects) will receive Famotidine 40 mg on Days 5, 9 and 13.
Drug: Famotidine
Other Name: Famotidine 40 mg

Experimental: Part 2 (Cenicriviroc)
Part 2 (24 subjects) will receive Cenicriviroc from Days 1-10 and Days 11-20.
Drug: Cenicriviroc
Other Name: Cenicriviroc 150 mg

Active Comparator: Part 2 (Omeprazole)
Part 2 (24 subjects) will receive Omeprazole from Days 11-20.
Drug: Omeprazole
Other Names:
  • Omeprazole 20 mg
  • Omeprazole 40 mg




Primary Outcome Measures :
  1. Pharmacokinetic Assessment of CVC, as measured by maximum plasma concentration (Cmax) [ Time Frame: Days 1, 7, and 13 for Part 1 Group 1. Days 1, 5, 9, and 13 for Part 1 Group 2. ]
  2. Pharmacokinetic Assessment of CVC, as measured by minimum plasma concentration (Cmin) [ Time Frame: Days 1, 7, and 13 for Part 1 Group 1. Days 1, 5, 9, and 13 for Part 1 Group 2. ]
  3. Pharmacokinetic Assessment of CVC, as measured by area under the plasma concentration-time curve (AUC) [ Time Frame: Days 1, 7, and 13 for Part 1 Group 1. Days 1, 5, 9, and 13 for Part 1 Group 2. ]

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, hematology and urinalysis

  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



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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.
  • 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.

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): NCT02684799


Locations
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United States, Florida
SeaView Research, Inc.
Miami, Florida, United States, 33126
Sponsors and Collaborators
Tobira Therapeutics, Inc.
Investigators
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Study Director: Star Seyedkazemi, PharmD Tobira Therapeutics, Inc.

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Responsible Party: Tobira Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02684799     History of Changes
Other Study ID Numbers: 652-123
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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Famotidine
Omeprazole
TAK-652
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
CCR5 Receptor Antagonists
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents