Healthy
Conditions
Keywords
Canagliflozin (JNJ-28431754), Pharmacokinetic, Dose proportionality
Brief summary
The purpose of this study is to evaluate the effect of dose on the pharmacokinetics of canagliflozin in healthy volunteers.
Detailed description
This is an open-label study where healthy volunteers will know the name and dose of assigned treatment and will be randomly assigned to take a single oral (by mouth) dose of canagliflozin sequentially in each of 3 treament periods where the dose in each treatment period will be different (referred to as a 3-period crossover study) to evaluate the pharmacokinetics (blood levels) of 3 dose levels of canagliflozin. Healthy volunteers will take a single oral tablet of canagliflozin 50 mg (Treatment A), 100 mg (Treatment B), and 300 mg (Treatment C) during the study; a different dose will be taken in each treatment period. Study drug will be taken in the a.m. on Day 1 of Treatment Periods 1, 2, and 3, with a 10- to 14-day washout period between Day 1 of each treatment period. Volunteers will fast (go without food) for at least 10 hours before and up to at least 4 hours after taking study drug.
Interventions
DRUGCanagliflozin, 50 mg
Type=1, unit=mg, number=50, form=tablet, route=oral use.Tablet is taken once without food during 1 of 3 treatment periods.
Type=1, unit=mg, number=300, form=tablet, route=oral use. Tablet is taken once without food during 1 of 3 treatment periods.
Type=1, unit=mg, number=100, form=tablet, route=oral use. Tablet is taken once without food during 1 of 3 treatment periods.
Sponsors
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study design
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteers with a body mass index between 18 and 30 kg/m2 (inclusive) and body weight not less than 50 kg
Exclusion criteria
* History of or current medical illness deemed clinically significant by the Investigator (study physician)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentrations of canagliflozin | For up to 12 days (4 days during treatment periods 1, 2, and 3) |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events | Up to approximately 42 days (includes up to 14 days between Treatment Periods 1 and 2 and up to 10 days after Day 4 of Treatment Period 3) |
| Clinical laboratory tests | Up to approximately 42 days |
| Physical examinations | Up to approximately 42 days |
| 12-lead electrocardiograms (ECGs) | Up to approximately 42 days |
| Vital signs | Up to approximately 42 days |
Countries
Belgium
Outcome results
None listed