A Study to Assess the Effects of Multiple-Dose Probenecid on the Multiple-Dose Pharmacokinetics of Canagliflozin in Healthy Volunteers

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Open-Label, Fixed-Sequence Study to Assess the Effects of Multiple-Dose Probenecid on the Multiple-Dose Pharmacokinetics of Canagliflozin in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Canagliflozin/Probenecid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 001<br>Canagliflozin/Probenecid | Drug: Canagliflozin/Probenecid<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentrations of Canagliflozin (including canagliflozin metabolites) |  | Up to Day 18 | 
| Plasma concentrations of probenecid |  | Up to Day 17 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | The number and type of adverse events | Up to 10 days following Day 18 | 
| Clinical Laboratory Tests | Clinically relevant changes occurring in laboratory safety parameters | Up to 10 days following Day 18 | 
| Vital Signs | Blood pressure and pulse | Up to 10 days following Day 18 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probenecid, Healthy Volunteers, Canagliflozin (JNJ-28431754), Pharmacokinetic