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

NCT ID: NCT01714206

Last Updated: 2012-11-19

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

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2009-09-30

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) of multiple doses of digoxin. The safety and tolerability of canagliflozin will also be assessed in healthy volunteers.

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), randomized (the treatment is assigned by chance), multiple dose, cross-over study (all volunteers will switch from one treatment to another) to determine how canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus) affects the pharmacokinetics of digoxin (a drug used to treat various heart conditions). Volunteers will be randomly assigned to 1 of 2 treatment sequence groups: Group AB or Group BA. Volunteers assigned to Group AB will be given Treatment A: digoxin once a day for 7 days. Volunteers assigned to Group BA will be given Treatment B: digoxin and canagliflozin once a day for 7 days. A washout period (when no medication is given) of at least 14 days will follow the first 7-day treatment period. Following the washout period, volunteers will be assigned to the treatment that they did not receive during the first treatment period. This second treatment period will last for 7 days. Each volunteer will participate in the study for approximately 60 days.

Conditions

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Healthy

Keywords

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Healthy Canagliflozin (JNJ-28431754) Pharmacokinetics Digoxin (LANOXIN)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment A

Each volunteer will receive digoxin once daily on Days 1 through 7.

Group Type ACTIVE_COMPARATOR

Digoxin 0.5 mg

Intervention Type DRUG

Two 0.25 mg tablets (0.5 mg total dose) taken orally (by mouth) on Day 1.

Digoxin 0.25 mg

Intervention Type DRUG

One 0.25 mg tablet taken orally on Days 2 through 7.

Treatment B

Each volunteer will receive digoxin once daily on Days 1 through 7 in combination with canagliflozin (JNJ-28431754) once daily on Days 1 through 7.

Group Type EXPERIMENTAL

Digoxin 0.5 mg

Intervention Type DRUG

Two 0.25 mg tablets (0.5 mg total dose) taken orally (by mouth) on Day 1.

Digoxin 0.25 mg

Intervention Type DRUG

One 0.25 mg tablet taken orally on Days 2 through 7.

Canagliflozin (JNJ-28431754)

Intervention Type DRUG

One 300 mg tablet taken orally on Days 1 through 7.

Interventions

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Digoxin 0.5 mg

Two 0.25 mg tablets (0.5 mg total dose) taken orally (by mouth) on Day 1.

Intervention Type DRUG

Digoxin 0.25 mg

One 0.25 mg tablet taken orally on Days 2 through 7.

Intervention Type DRUG

Canagliflozin (JNJ-28431754)

One 300 mg tablet taken orally on Days 1 through 7.

Intervention Type DRUG

Other Intervention Names

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Lanoxin Lanoxin 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

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

45 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, Vaccaro N, Bernard A, Skee D, Mamidi RN, Tian H, Weiner S, Stieltjes H, Sha S, Rothenberg P. Effect of canagliflozin, a sodium glucose co-transporter 2 inhibitor, on the pharmacokinetics of oral contraceptives, warfarin, and digoxin in healthy participants. Int J Clin Pharmacol Ther. 2015 Jan;53(1):41-53. doi: 10.5414/CP202157.

Reference Type DERIVED
PMID: 25345427 (View on PubMed)

Other Identifiers

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28431754DIA1014

Identifier Type: OTHER

Identifier Source: secondary_id

CR016465

Identifier Type: -

Identifier Source: org_study_id