A Study to Assess the Effects of Multiple-Dose Probenecid on the Multiple-Dose Pharmacokinetics of Canagliflozin in Healthy Volunteers
- Conditions
- Healthy
- Interventions
- Drug: Canagliflozin/Probenecid
- Registration Number
- NCT01428284
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
Body mass index (BMI) between 18 and 28 kg/m² inclusive and a body weight of not less than 50 kg.
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 001 Canagliflozin/Probenecid Canagliflozin/Probenecid
- Primary Outcome Measures
Name Time Method Plasma concentrations of Canagliflozin (including canagliflozin metabolites) Up to Day 18 Plasma concentrations of probenecid Up to Day 17
- Secondary Outcome Measures
Name Time Method Adverse Events Up to 10 days following Day 18 The number and type of adverse events
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