A Study to Assess the Effects of Canagliflozin (JNJ-28431754) on the Pharmacokinetics and Safety of Digoxin in Healthy Volunteers.
Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Digoxin 0.5 mg (Drug); Digoxin 0.25 mg (Drug); Canagliflozin (JNJ-28431754) (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Official(s) and/or principal investigator(s): Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Plasma concentration of digoxinUrine concentration of digoxin
Secondary outcome: There are no secondary outcome measures
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
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: June 2009
Last updated: November 16, 2012
|