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

NCT ID: NCT02685462

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-02-23

Brief Summary

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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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1 (Rosuvastatin)

Group 1 (12 subjects) will receive Rosuvastatin on Days 1 and 13.

Group Type ACTIVE_COMPARATOR

Rosuvastatin

Intervention Type DRUG

Group 1 (Digoxin)

Group 1 (12 subjects) will receive Digoxin on Days 1 and 13.

Group Type ACTIVE_COMPARATOR

Digoxin

Intervention Type DRUG

Group 1 (Caffeine)

Group 1 (12 subjects) will receive Caffeine on Days 1 and 13.

Group Type ACTIVE_COMPARATOR

Caffeine

Intervention Type DRUG

Group 2 (Atorvastatin)

Group 2 (12 subjects) will receive Atorvastatin on Days 1 and 13.

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

Rosuvastatin

Intervention Type DRUG

Atorvastatin

Intervention Type DRUG

Simvastatin

Intervention Type DRUG

Digoxin

Intervention Type DRUG

Caffeine

Intervention Type DRUG

Group 3 (Simvastatin)

Group 3 (12 subjects) will receive Simvastatin on Days 1 and 12.

Group Type ACTIVE_COMPARATOR

Simvastatin

Intervention Type DRUG

Interventions

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Rosuvastatin

Intervention Type DRUG

Atorvastatin

Intervention Type DRUG

Simvastatin

Intervention Type DRUG

Digoxin

Intervention Type DRUG

Caffeine

Intervention Type DRUG

Other Intervention Names

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Rosuvastatin 20 mg Atorvastatin 20 mg Simvastatin 20 mg Digoxin 0.25 mg Caffine 200 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.
* 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.
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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Millie Gottwald, PharmD

Role: STUDY_DIRECTOR

Tobira Therapeutics, Inc.

Locations

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Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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652-124

Identifier Type: -

Identifier Source: org_study_id