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Completed

NCT Number: NCT01428284

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

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.

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Key information

Conditions

Age range

15 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Overland Park, Kansas, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Canagliflozin/Probenecid

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Sep 2, 2011
Registry last updated
Feb 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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