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

NCT02684799 | Completed Phase 1

• 1 other identifier: 652-123
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetic Assessment of CVC, as measured by maximum plasma concentration (Cmax)

  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)

  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)

  Days 1, 7, and 13 for Part 1 Group 1. Days 1, 5, 9, and 13 for Part 1 Group 2.

Secondary Outcomes (5)

• Evaluation of Adverse Events

  23 days

• Changes from Baseline in Clinical Laboratory Tests

  Baseline and 23 days

• Changes from Baseline in 12-lead ECGs

  Baseline and 23 days

• Changes from Baseline in Vital Signs

  Baseline and 23 days

• Changes from Baseline in Physical Examinations

  Baseline and 23 days

Study Arms (6)

Part 1 Group 1 (Cenicriviroc)

EXPERIMENTAL

Part 1 Group 1 (12 subjects) will receive CVC 150 mg on Days 1, 7 and 13.

Drug: Cenicriviroc

Part 1 Group 1 (Omeprazole)

ACTIVE COMPARATOR

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

Part 1 Group 2 (Cenicriviroc)

EXPERIMENTAL

Part 1 Group 2 (12 subjects) will receive CVC 150 mg on Days 1, 5, 9 and 13.

Drug: Cenicriviroc

Part 1 Group 2 (Famotidine)

ACTIVE COMPARATOR

Part 1 Group 2 (12 subjects) will receive Famotidine 40 mg on Days 5, 9 and 13.

Drug: Famotidine

Part 2 (Cenicriviroc)

EXPERIMENTAL

Part 2 (24 subjects) will receive Cenicriviroc from Days 1-10 and Days 11-20.

Drug: Cenicriviroc

Part 2 (Omeprazole)

ACTIVE COMPARATOR

Part 2 (24 subjects) will receive Omeprazole from Days 11-20.

Drug: Omeprazole

Interventions

Cenicriviroc DRUG

Also known as: Cenicriviroc 150 mg

Part 1 Group 1 (Cenicriviroc); Part 1 Group 2 (Cenicriviroc); Part 2 (Cenicriviroc)

Omeprazole DRUG

Also known as: Omeprazole 20 mg, Omeprazole 40 mg

Part 1 Group 1 (Omeprazole); Part 2 (Omeprazole)

Famotidine DRUG

Also known as: Famotidine 40 mg

Part 1 Group 2 (Famotidine)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tobira Therapeutics, Inc.: lead

Study Sites (1)

SeaView Research, Inc.

Miami, Florida, 33126, United States

Location

MeSH Terms

Interventions

cenicriviroc; Omeprazole; Famotidine

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiazoles; Azoles

Study Officials

• Star Seyedkazemi, PharmD

  Tobira Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2016
• First Posted: February 18, 2016
• Study Start: January 31, 2016
• Primary Completion: April 11, 2016
• Study Completion: April 11, 2016
• Last Updated: November 24, 2017

Record last verified: 2017-11

Locations

US (1)