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

• ClinicalTrials.gov Identifier: NCT02684799
• Recruitment Status: Completed
• First Posted: February 18, 2016
• Last Update Posted: November 24, 2017
• Sponsor: Tobira Therapeutics, Inc.
• Information provided by (Responsible Party): Tobira Therapeutics, Inc.

Tracking Information

• First Submitted Date: February 3, 2016
• First Posted Date: February 18, 2016
• Last Update Posted Date: November 24, 2017
• Actual Study Start Date: January 31, 2016
• Actual Primary Completion Date: April 11, 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 17, 2016)

• 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. ]
• 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. ]
• 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. ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 17, 2016)

• 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, hematology and urinalysis
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Pharmacokinetic and Safety Study of Cenicriviroc and Acid Reducing Agents When Dosed Alone or in Combination
• 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)
• 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
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Healthy

Intervention

• Drug: Cenicriviroc
  Other Name: Cenicriviroc 150 mg
• Drug: Omeprazole
  Other Names:

  • Omeprazole 20 mg
  • Omeprazole 40 mg
• Drug: Famotidine
  Other Name: Famotidine 40 mg

Study Arms

• Experimental: Part 1 Group 1 (Cenicriviroc)
  Part 1 Group 1 (12 subjects) will receive CVC 150 mg on Days 1, 7 and 13.
  Intervention: Drug: Cenicriviroc
• 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.
  Intervention: Drug: Omeprazole
• Experimental: Part 1 Group 2 (Cenicriviroc)
  Part 1 Group 2 (12 subjects) will receive CVC 150 mg on Days 1, 5, 9 and 13.
  Intervention: Drug: Cenicriviroc
• Active Comparator: Part 1 Group 2 (Famotidine)
  Part 1 Group 2 (12 subjects) will receive Famotidine 40 mg on Days 5, 9 and 13.
  Intervention: Drug: Famotidine
• Experimental: Part 2 (Cenicriviroc)
  Part 2 (24 subjects) will receive Cenicriviroc from Days 1-10 and Days 11-20.
  Intervention: Drug: Cenicriviroc
• Active Comparator: Part 2 (Omeprazole)
  Part 2 (24 subjects) will receive Omeprazole from Days 11-20.
  Intervention: Drug: Omeprazole

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 17, 2016): 48
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: April 11, 2016
• Actual Primary Completion Date: April 11, 2016 (Final data collection date for primary outcome measure)

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.
• 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02684799
• Other Study ID Numbers: 652-123
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Tobira Therapeutics, Inc.
• Study Sponsor: Tobira Therapeutics, Inc.
• Collaborators: Not Provided

Investigators

• Study Director: Star Seyedkazemi, PharmD; Tobira Therapeutics, Inc.

• PRS Account: Tobira Therapeutics, Inc.
• Verification Date: November 2017