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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2011

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

  • Drug: Canagliflozin/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).

Arms, Groups and Cohorts

  • Experimental: 001
    • Canagliflozin/Probenecid

Clinical Trial Outcome Measures

Primary Measures

  • Plasma concentrations of Canagliflozin (including canagliflozin metabolites)
    • Time Frame: Up to Day 18
  • Plasma concentrations of probenecid
    • Time Frame: Up to Day 17

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 15 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  • Provider of Information About this Clinical Study
    • Director, Clinical Pharmacology, Johnson & Johnson Pharmaceutical Research and Development, L.L.C
  • Overall Official(s)
    • Johnson & Johnson Pharmaceutical Research and Development, L.L.C Clinical Trial, Study Director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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