NCT01714206

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jun 2009

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 25, 2012

Completed
Last Updated

November 19, 2012

Status Verified

November 1, 2012

Enrollment Period

3 months

First QC Date

October 23, 2012

Last Update Submit

November 16, 2012

Conditions

Healthy

Keywords

HealthyCanagliflozin (JNJ-28431754)PharmacokineticsDigoxin (LANOXIN)

Outcome Measures

Primary Outcomes (2)

  • Plasma concentration of digoxin

    Comparison of plasma concentrations of digoxin following administration of digoxin alone (Treatment A) or in combination with canagliflozin (JNJ-28431754) (Treatment B). This will be used to determine whether there is a pharmacokinetic interaction between digoxin and canagliflozin.

    Days 5 through 7

  • Urine concentration of digoxin

    Comparison of the urine concentrations of digoxin following administration of digoxin alone (Treatment A) or in combination with canagliflozin (JNJ-28431754) (Treatment B). This will be used to determine whether there is a pharmacokinetic interaction between canagliflozin and digoxin.

    Day 7

Secondary Outcomes (1)

  • There are no secondary outcome measures

Study Arms (2)

Treatment A

ACTIVE COMPARATOR

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

Drug: Digoxin 0.5 mgDrug: Digoxin 0.25 mg

Treatment B

EXPERIMENTAL

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.

Drug: Digoxin 0.5 mgDrug: Digoxin 0.25 mgDrug: Canagliflozin (JNJ-28431754)

Interventions

Digoxin 0.5 mgDRUG

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

Also known as: Lanoxin
Treatment ATreatment B
Digoxin 0.25 mgDRUG

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

Also known as: Lanoxin
Treatment ATreatment B
Canagliflozin (JNJ-28431754)DRUG

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

Also known as: JNJ-28431754
Treatment B

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 25345427DERIVED

MeSH Terms

Interventions

DigoxinCanagliflozin

Intervention Hierarchy (Ancestors)

Digitalis GlycosidesCardenolidesCardiac GlycosidesCardanolidesSteroidsFused-Ring CompoundsPolycyclic CompoundsGlycosidesCarbohydratesThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic CompoundsGlucosides

Study Officials

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

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

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 23, 2012

First Posted

October 25, 2012

Study Start

June 1, 2009

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

November 19, 2012

Record last verified: 2012-11