A Single and Multiple Dose Study of Canagliflozin in Healthy Volunteers

NCT01281579 | Completed Phase 1

• 2 other identifiers: CR01769528431754DIA1030
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Healthy

Keywords

Pharmacokinetics; Pharmacodynamics; Canagliflozin

Outcome Measures

Primary Outcomes (4)

• Plasma concentrations of canagliflozin

  At protocol-specified times up to Day 14

• Urine concentrations of canagliflozin

  At protocol-specified times up to Day 11

• Plasma glucose concentrations

  At protocol-specified times up to Day 11

• Urine glucose concentrations

  At protocol-specified times up to Day 11

Secondary Outcomes (2)

• The number and type of adverse events reported

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

• Changes in hematology, chemistry and urinalysis parameters

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

Study Arms (3)

001

EXPERIMENTAL

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

Drug: Canagliflozin 50 mg

002

EXPERIMENTAL

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

Drug: Canagliflozin 100 mg

003

EXPERIMENTAL

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

Drug: Canagliflozin 300 mg

Interventions

Canagliflozin 100 mg DRUG

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

002

Canagliflozin 50 mg DRUG

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

001

Canagliflozin 300 mg DRUG

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

003

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

MeSH Terms

Interventions

Canagliflozin

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2011
• First Posted: January 24, 2011
• Study Start: January 1, 2011
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: November 30, 2012

Record last verified: 2012-11