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Completed

NCT Number: NCT01281579

A Single and Multiple Dose Study of Canagliflozin in Healthy Volunteers

The purpose of this study is to determine blood and urine concentrations of canagliflozin and glucose in healthy adult volunteers after administration of single and multiple doses of canagliflozin.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

This is an open-label (volunteers and study staff will know the name and dose of the treatment assigned), single-center study of canagliflozin (JNJ-28431754) in healthy adult volunteers. Canagliflozin (a sodium-glucose cotransporter 2-inhibitor) is currently under development to lower blood sugar levels in patients with Type 2 diabetes mellitus (T2DM). Healthy volunteers will take canagliflozin 50 mg, 100 mg, or 300 mg tablets, orally (by mouth), once daily on Day 1 and on Days 4 to 9. All study drug administration will occur at approximately the same time each morning with 240 mL of noncarbonated water and will be followed by a standardized breakfast within 10 minutes.

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 (BMI, a measure of a person's weight in relation to height) between 18 and 30 kg/m2, inclusive, and a body weight of not less than 50 kg

Exclusion criteria

  • History of or current clinically significant medical illness as determined by the Investigator
  • History of clinically significant allergies, especially known hypersensitivity or intolerance to drugs or lactose
  • Known allergy to canagliflozin or any of the excipients of the formulation of canagliflozin

Treatment and study plan

Canagliflozin 100 mg

Drug

Tablets, oral, 100-mg, once daily on Day 1 and on Days 4 through 9.

Canagliflozin 50 mg

Drug

Tablets, oral, 50-mg, once daily on Day 1 and on Days 4 through 9.

Canagliflozin 300 mg

Drug

Tablets, oral, 300-mg, once daily on Day 1 and on Days 4 through 9.

Primary outcomes

  1. Plasma concentrations of canagliflozin

    Time frame: At protocol-specified times up to Day 14

  2. Urine concentrations of canagliflozin

    Time frame: At protocol-specified times up to Day 11

  3. Plasma glucose concentrations

    Time frame: At protocol-specified times up to Day 11

  4. Urine glucose concentrations

    Time frame: At protocol-specified times up to Day 11

Secondary outcomes

  1. The number and type of adverse events reported

    Time frame: Up to 10 days after last dose" (last dose is given on Day 9)

  2. Changes in hematology, chemistry and urinalysis parameters

    Time frame: Up to 10 days after last dose" (last dose is given on Day 9)

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

An Open-Label, Randomized, Parallel-Group, Single-Center Study to Evaluate the Single and Multiple Dose Pharmacokinetic and Pharmacodynamic Characteristics of JNJ-28431754 (Canagliflozin) in Healthy Subjects

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 24, 2011
Registry last updated
Nov 30, 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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