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A Pharmacokinetic Dose Proportionality Study of Canagliflozin in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT01340677
First received: April 21, 2011
Last updated: August 16, 2012
Last verified: August 2012
History of Changes

April 21, 2011
August 16, 2012
May 2011
August 2011   (final data collection date for primary outcome measure)
Plasma concentrations of canagliflozin [ Time Frame: For up to 12 days (4 days during treatment periods 1, 2, and 3) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01340677 on ClinicalTrials.gov Archive Site
  • 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) ] [ Designated as safety issue: No ]
  • Clinical laboratory tests [ Time Frame: Up to approximately 42 days ] [ Designated as safety issue: No ]
  • Physical examinations [ Time Frame: Up to approximately 42 days ] [ Designated as safety issue: No ]
  • 12-lead electrocardiograms (ECGs) [ Time Frame: Up to approximately 42 days ] [ Designated as safety issue: No ]
  • Vital signs [ Time Frame: Up to approximately 42 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Pharmacokinetic Dose Proportionality Study of Canagliflozin in Healthy Volunteers
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

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

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.
Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
  • Drug: Canagliflozin, 50 mg
    Type=1, unit=mg, number=50, form=tablet, route=oral use.Tablet is taken once without food during 1 of 3 treatment periods.
  • Drug: Canagliflozin, 300 mg
    Type=1, unit=mg, number=300, form=tablet, route=oral use. Tablet is taken once without food during 1 of 3 treatment periods.
  • Drug: Canagliflozin, 100 mg
    Type=1, unit=mg, number=100, form=tablet, route=oral use. Tablet is taken once without food during 1 of 3 treatment periods.
Experimental: 001
Canagliflozin 100 mg Type=1 unit=mg number=100 form=tablet route=oral use. Tablet is taken once without food during 1 of 3 treatment periods.,Canagliflozin 300 mg Type=1 unit=mg number=300 form=tablet route=oral use. Tablet is taken once without food during 1 of 3 treatment periods.,Canagliflozin 50 mg Type=1 unit=mg number=50 form=tablet route=oral use.Tablet is taken once without food during 1 of 3 treatment periods.
Interventions:
  • Drug: Canagliflozin, 50 mg
  • Drug: Canagliflozin, 300 mg
  • Drug: Canagliflozin, 100 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
August 2011
August 2011   (final data collection date for primary outcome measure)

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)
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01340677
CR018277, 28431754DIA1015, 2010-023251-28
Not Provided
Director, Clinical Pharmacology, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Not Provided
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP