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

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (Industry)

Overall Status

Completed

CT.gov ID

NCT01714206

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Digoxin 0.5 mg Drug: Digoxin 0.25 mg Drug: Canagliflozin (JNJ-28431754)	Phase 1

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-Label, 2-Period, Crossover Study to Evaluate the Effects of Multiple Doses of JNJ-28431754 on the Pharmacokinetics of Multiple Doses of Digoxin in Healthy Subjects.

Study Start Date :

Jun 1, 2009

Actual Primary Completion Date :

Sep 1, 2009

Actual Study Completion Date :

Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Treatment A Each volunteer will receive digoxin once daily on Days 1 through 7.	Drug: Digoxin 0.5 mg Two 0.25 mg tablets (0.5 mg total dose) taken orally (by mouth) on Day 1. Other Names: Lanoxin Drug: Digoxin 0.25 mg One 0.25 mg tablet taken orally on Days 2 through 7. Other Names: Lanoxin
Experimental: 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.	Drug: Digoxin 0.5 mg Two 0.25 mg tablets (0.5 mg total dose) taken orally (by mouth) on Day 1. Other Names: Lanoxin Drug: Digoxin 0.25 mg One 0.25 mg tablet taken orally on Days 2 through 7. Other Names: Lanoxin Drug: Canagliflozin (JNJ-28431754) One 300 mg tablet taken orally on Days 1 through 7. Other Names: JNJ-28431754

Arm

Intervention/Treatment

Active Comparator: Treatment A

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

Drug: Digoxin 0.5 mg

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

Other Names:

Lanoxin

Drug: Digoxin 0.25 mg

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

Other Names:

Lanoxin

Experimental: 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.

Drug: Digoxin 0.5 mg

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

Other Names:

Lanoxin

Drug: Digoxin 0.25 mg

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

Other Names:

Lanoxin

Drug: Canagliflozin (JNJ-28431754)

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

Other Names:

JNJ-28431754

Outcome Measures

Primary Outcome Measures

Plasma concentration of digoxin [Days 5 through 7]
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.
Urine concentration of digoxin [Day 7]
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.

Secondary Outcome Measures

There are no secondary outcome measures []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.