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

NCT ID: NCT02684799

Last Updated: 2017-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-04-11

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1 Group 1 (Cenicriviroc)

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

Group Type EXPERIMENTAL

Cenicriviroc

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Omeprazole

Intervention Type DRUG

Part 1 Group 2 (Cenicriviroc)

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

Group Type EXPERIMENTAL

Cenicriviroc

Intervention Type DRUG

Part 1 Group 2 (Famotidine)

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

Group Type ACTIVE_COMPARATOR

Famotidine

Intervention Type DRUG

Part 2 (Cenicriviroc)

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

Group Type EXPERIMENTAL

Cenicriviroc

Intervention Type DRUG

Part 2 (Omeprazole)

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

Group Type ACTIVE_COMPARATOR

Omeprazole

Intervention Type DRUG

Interventions

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Cenicriviroc

Intervention Type DRUG

Omeprazole

Intervention Type DRUG

Famotidine

Intervention Type DRUG

Other Intervention Names

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Cenicriviroc 150 mg Omeprazole 20 mg Omeprazole 40 mg Famotidine 40 mg

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tobira Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Star Seyedkazemi, PharmD

Role: STUDY_DIRECTOR

Tobira Therapeutics, Inc.

Locations

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SeaView Research, Inc.

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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652-123

Identifier Type: -

Identifier Source: org_study_id