A Study to Assess the Effects of Canagliflozin (JNJ-28431754) on the Pharmacokinetics and Safety of Digoxin in Healthy Volunteers.
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Digoxin 0.5 mg Drug: Digoxin 0.25 mg Drug: Canagliflozin (JNJ-28431754) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: 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. |
- Plasma concentration of digoxin [ Time Frame: Days 5 through 7 ] [ Designated as safety issue: No ]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 [ Time Frame: Day 7 ] [ Designated as safety issue: No ]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.
- There are no secondary outcome measures [ Designated as safety issue: No ]
| Enrollment: | 18 |
| Study Start Date: | June 2009 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: Lanoxin
Drug: Digoxin 0.25 mg
One 0.25 mg tablet taken orally on Days 2 through 7.
Other Name: 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 Name: Lanoxin
Drug: Digoxin 0.25 mg
One 0.25 mg tablet taken orally on Days 2 through 7.
Other Name: Lanoxin
Drug: Canagliflozin (JNJ-28431754)
One 300 mg tablet taken orally on Days 1 through 7.
Other Name: JNJ-28431754
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| 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| Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
More Information
No publications provided
| Responsible Party: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| ClinicalTrials.gov Identifier: | NCT01714206 History of Changes |
| Other Study ID Numbers: | CR016465, 28431754DIA1014 |
| Study First Received: | October 23, 2012 |
| Last Updated: | November 16, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
|
Healthy Canagliflozin (JNJ-28431754) Pharmacokinetics Digoxin (LANOXIN) |
Additional relevant MeSH terms:
|
Digoxin Cardiotonic Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Arrhythmia Agents Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013