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Completed

NCT Number: NCT01340677

A Pharmacokinetic Dose Proportionality Study of Canagliflozin in Healthy Volunteers

The purpose of this study is to evaluate the effect of dose on the pharmacokinetics of canagliflozin in healthy volunteers.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Merksem, Belgium

About this study

This is an open-label study where healthy volunteers will know the name and dose of assigned treatment and will be randomly assigned to take a single oral (by mouth) dose of canagliflozin sequentially in each of 3 treament periods where the dose in each treatment period will be different (referred to as a 3-period crossover study) to evaluate the pharmacokinetics (blood levels) of 3 dose levels of canagliflozin. Healthy volunteers will take a single oral tablet of canagliflozin 50 mg (Treatment A), 100 mg (Treatment B), and 300 mg (Treatment C) during the study; a different dose will be taken in each treatment period. Study drug will be taken in the a.m. on Day 1 of Treatment Periods 1, 2, and 3, with a 10- to 14-day washout period between Day 1 of each treatment period. Volunteers will fast (go without food) for at least 10 hours before and up to at least 4 hours after taking study drug.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy volunteers with a body mass index between 18 and 30 kg/m2 (inclusive) and body weight not less than 50 kg

Exclusion criteria

  • History of or current medical illness deemed clinically significant by the Investigator (study physician)

Treatment and study plan

Canagliflozin, 50 mg

Drug

Type=1, unit=mg, number=50, form=tablet, route=oral use.Tablet is taken once without food during 1 of 3 treatment periods.

Canagliflozin, 300 mg

Drug

Type=1, unit=mg, number=300, form=tablet, route=oral use. Tablet is taken once without food during 1 of 3 treatment periods.

Canagliflozin, 100 mg

Drug

Type=1, unit=mg, number=100, form=tablet, route=oral use. Tablet is taken once without food during 1 of 3 treatment periods.

Primary outcomes

  1. Plasma concentrations of canagliflozin

    Time frame: For up to 12 days (4 days during treatment periods 1, 2, and 3)

Secondary outcomes

  1. Adverse events

    Time frame: Up to approximately 42 days (includes up to 14 days between Treatment Periods 1 and 2 and up to 10 days after Day 4 of Treatment Period 3)

  2. Clinical laboratory tests

    Time frame: Up to approximately 42 days

  3. Physical examinations

    Time frame: Up to approximately 42 days

  4. 12-lead electrocardiograms (ECGs)

    Time frame: Up to approximately 42 days

  5. Vital signs

    Time frame: Up to approximately 42 days

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

An Open-Label, Single-Dose, Randomized, 3-Period, Crossover Study to Evaluate the Pharmacokinetic Dose Proportionality of Canagliflozin of 50, 100, and 300 mg Under Fasted Conditions in Healthy Subjects

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 22, 2011
Registry last updated
Aug 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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