Healthy
Conditions
Keywords
Healthy Volunteers, Canagliflozin (JNJ-28431754), Pharmacokinetic, Probenecid
Brief summary
The purpose of this study is to assess the effects of multiple doses of probenecid on the multiple-dose pharmacokinetics of canagliflozin and its metabolites in healthy volunteers. Safety and tolerability will also be assessed.
Detailed description
This will be a single-center, open-label (identity of study treatments will be known to volunteers participating in the study as well as to study staff) study to assess the effects of multiple doses of probenecid on the multiple-dose pharmacokinetics of canagliflozin and its metabolites in healthy volunteers. The study will last up to approximately 49 days (includes a Screening Phase of up to 19 days, an Open-Label Treatment Phase of 20 days, and a Post-Treatment Phase of up to 7 to 10 days). Healthy volunteers will take orally (by mouth) one 300 mg canagliflozin tablet once daily and/or one 500-mg probenecid tablet twice daily in sequential order as follows: Days 1 to 14 (administration of canagliflozin alone) and Days 15 to 17 (administration of canagliflozin + twice-daily administration of probenecid). On days when both canagliflozin and probenecid are taken, both doses must be taken at approximately the same time.
Interventions
DRUGCanagliflozin/Probenecid
Canagliflozin: Type = 1, unit = mg, number = 300, form = tablet, route = oral use. Probenicid: Type = 1, unit = mg, number = 500, form = tablet, route = oral use. One 300-mg canagliflozin tablet taken orally once daily on Days 1 to 14 (administration of canagliflozin alone) and on Days 15 to 17 (administration of canagliflozin + twice-daily administration of probenecid).
Sponsors
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Body mass index (BMI) between 18 and 28 kg/m² inclusive and a body weight of not less than 50 kg.
Exclusion criteria
History of or current medical illness, abnormal values for hematology or clinical chemistry laboratory tests, or abnormal physical examination, vital signs or 12-lead electrocardiogram (ECG) deemed to be clinically significant by the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentrations of Canagliflozin (including canagliflozin metabolites) | Up to Day 18 |
| Plasma concentrations of probenecid | Up to Day 17 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Laboratory Tests | Up to 10 days following Day 18 | Clinically relevant changes occurring in laboratory safety parameters |
| Vital Signs | Up to 10 days following Day 18 | Blood pressure and pulse |
| Adverse Events | Up to 10 days following Day 18 | The number and type of adverse events |
Countries
United States
Outcome results
None listed