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A Study to Assess the Effects of Canagliflozin (JNJ-28431754) on the Pharmacokinetics, Pharmacodynamics, and Safety of Simvastatin in Healthy Volunteers

NCT ID: NCT01821027

Last Updated: 2013-03-29

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

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2008-09-30

Brief Summary

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The purpose of this study is to determine how multiple doses of canagliflozin (JNJ-28431754) affect the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how the drug affects the body) of a single dose of simvastatin.

Detailed Description

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This study will be an open-label (all volunteers and study staff know the identity of the assigned treatment), single-center, fixed-sequence study (all volunteers receive the same medication on the same days and in the same order) to determine how multiple doses of canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus) affects the pharmacokinetics and pharmacodynamics of a single dose of simvastatin (a drug used to treat raised cholesterol). The study will consist of 3 phases: a screening phase, an open-label treatment phase, and an end-of-study (or follow-up) phase. During the open-label treatment phase, each volunteer will receive a single 40 mg dose of simvastatin on Day 1, followed by 300 mg of canagliflozin once daily on Days 2 through 6. On Day 7, volunteers will receive both simvastatin 40 mg and canagliflozin 300 mg. Each volunteer will participate in the study for approximately 32 days

Conditions

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Healthy

Keywords

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Healthy Canagliflozin (JNJ-28431754) Pharmacokinetics Pharmacodynamics Simvastatin (ZOCOR)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Canagliflozin + simvastatin

Each volunteer will receive a single dose of simvastatin on Day 1, followed by canagliflozin (JNJ-28431754) once daily on Days 2 through 6. On Day 7 volunteers will receive a single dose of simvastatin in combination with a single dose of canagliflozin.

Group Type EXPERIMENTAL

Simvastatin

Intervention Type DRUG

One 40 mg tablet taken orally (by mouth) on Day 1 and Day 7.

Canagliflozin (JNJ-28431754)

Intervention Type DRUG

One 300 mg dose (ie, one 100 mg and one 200 mg over-encapsulated tablet) taken orally (by mouth) on Days 2 through Day 7.

Interventions

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Simvastatin

One 40 mg tablet taken orally (by mouth) on Day 1 and Day 7.

Intervention Type DRUG

Canagliflozin (JNJ-28431754)

One 300 mg dose (ie, one 100 mg and one 200 mg over-encapsulated tablet) taken orally (by mouth) on Days 2 through Day 7.

Intervention Type DRUG

Other Intervention Names

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Zocor JNJ-28431754

Eligibility Criteria

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Inclusion Criteria

* Volunteers must have a body mass index (BMI) (weight in kg/height in m2) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
* Volunteers must be non-smokers

Exclusion Criteria

\- History of, or current active illness, considered to be clinically significant by the Investigator, or any other illness that the Investigator considers should exclude the patient from the study, or that could interfere with the interpretation of the study results
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

References

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Devineni D, Manitpisitkul P, Murphy J, Skee D, Wajs E, Mamidi RN, Tian H, Vandebosch A, Wang SS, Verhaeghe T, Stieltjes H, Usiskin K. Effect of canagliflozin on the pharmacokinetics of glyburide, metformin, and simvastatin in healthy participants. Clin Pharmacol Drug Dev. 2015 May-Jun;4(3):226-36. doi: 10.1002/cpdd.166. Epub 2014 Oct 27.

Reference Type DERIVED
PMID: 27140803 (View on PubMed)

Other Identifiers

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28431754DIA1009

Identifier Type: OTHER

Identifier Source: secondary_id

CR015511

Identifier Type: -

Identifier Source: org_study_id