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

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ClinicalTrials.gov Identifier: NCT01428284
Recruitment Status : Completed
First Posted : September 2, 2011
Last Update Posted : February 17, 2012
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Canagliflozin/Probenecid Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 Start Date : August 2011
Primary Completion Date : October 2011
Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 001
Canagliflozin/Probenecid
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).



Primary Outcome Measures :
  1. Plasma concentrations of Canagliflozin (including canagliflozin metabolites) [ Time Frame: Up to Day 18 ]
  2. Plasma concentrations of probenecid [ Time Frame: Up to Day 17 ]

Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: Up to 10 days following Day 18 ]
    The number and type of adverse events

  2. Clinical Laboratory Tests [ Time Frame: Up to 10 days following Day 18 ]
    Clinically relevant changes occurring in laboratory safety parameters

  3. Vital Signs [ Time Frame: Up to 10 days following Day 18 ]
    Blood pressure and pulse



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01428284


Locations
United States, Kansas
Overland Park, Kansas, United States
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L.C Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Responsible Party: Director, Clinical Pharmacology, Johnson & Johnson Pharmaceutical Research and Development, L.L.C
ClinicalTrials.gov Identifier: NCT01428284     History of Changes
Other Study ID Numbers: CR018736
28431754DIA1048 ( Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C )
First Posted: September 2, 2011    Key Record Dates
Last Update Posted: February 17, 2012
Last Verified: February 2012

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Healthy Volunteers
Canagliflozin (JNJ-28431754)
Pharmacokinetic
Probenecid

Additional relevant MeSH terms:
Canagliflozin
Probenecid
Hypoglycemic Agents
Physiological Effects of Drugs
Uricosuric Agents
Gout Suppressants
Antirheumatic Agents
Renal Agents